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Johnson & Johnson Ethicrap, I Mean EthiCON, More JNJ JUNK

As I've mentioned, Johnson & Johnson has so many bad products I have to put a bunch in each article now to try to keep up. Now for EthiCON crap.

Date Created: 2016, July 26

Keywords: Johnson and Johnson, Johnson & Johnson, ethicon, harmonic ace, morcellator, physiomesh, secure strap, stapler

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Today: 355
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Many people know that Johnson & Johnson is not a single company. The company is a 'holding company' of over 275 subsidiaries. While I still have not been able to find a source for a regularly updated list, I figured I'd go through a few of their better-known subsidiaries and see how many issues I found. I got a few done and will start with what I found out about Johnson & Johnson's Ethicon subsidiary. What I found was amazing - even worse than I could have imagined, and this is just ONE subsidiary. I'm sure there are more to come as I start going through the risks of each and every Johnson & Johnson subsidiary I find....
 
MAUDE is the acronym for Manufacturer and User Facility Device Experience, a searchable database of voluntarily submitted notes of problems with medical devices. Searching MAUDE is quite easy, actually. Add information to at least one field and a list of the issues related to the search are returned. To begin my search for reports regarding problems with Johnson & Johnson's Ethicon, I simply entered "Ethicon" in the "Brand Name" field and selected two years' of data. This link takes you to MAUDE results for "Ethicon" from 06/01/2014 to 05/31/2016... As you can see if you checked out the link, well, there are a WHOLE LOT of complaints about a variety of Johnson & Johnson Ethicrap, I mean EthiCON products.
 
One of the products with numerous complaints is HARMONIC ACE®+ Shears. They are a special tool that seals blood vessels while cutting, reducing risk of heavy bleeding and makes it easier for the surgeon to see what he is doing without a ton of sponges in the way. Excellent tool, when they work, eh? At $600+ each single use disposable unit, you would think they'd be a dependable product, but it seems this is yet another defective, undependable, Johnson & Johnson product. Here are some of the complaints from the operating room regarding this device:
- Melted during surgery
- Plastic from harmonic handpiece fell off during procedure into patient.
- When first plugging the shears into machine, the words 'test failure' appeared and the device would not work.
- Shears were not sealing, made a sizzling sound and sparked. Caused patient to have uncontrollable bleeding. Had to get another hand piece to stop bleeding and put in a stitch.
 
Another popular product with multiple failure submissions is ETHICON ENDO-SURGERY, LLC ETHICON ACE+7 LAPAROSCOPIC SHEARS 5MM 36CM. A perfect example of this cheap crap device: A (b)(6) female came into the operating room and underwent laparoscopic bilateral tubal ligation. A piece of the grasper broke off inside the patient's abdomen.
 
And the list goes on. I just got tired of going through it all and figured people would have enough to get the point: Johnson & Johnson Ethicon Surgical Tools SUCK, eh?
 
ETHICON ETHICON 4.0 VICRYL SUTURE
Tip broke off in patient.
 
ETHICON SECURESTRAP® Absorbable Strap Fixation Device
Ethicon securestrap- 2 devices malfunctioned. One device fired numerous blank straps without device indicator turning orange (lot jlk983). Second device fired approximately 10 straps and the rest were blank - the indicator did turn orange after the approx. 10 straps were fired (lot jlm634).
 
I was actually kind of wondering if I was exaggerating things a bit since I totally dislike anything about Johnson & Johnson after all of the research I've done. So, I tried to be a bit unbiased, seriously, I looked into any hint of issues with parts of products left in people after surgery, not just sponges and such which should be monitored closely by surgical staff, but the incidence of actual parts of broken cheap crap left inside people during surgery. And here is what I found...
 
In January of 2008, the United States Food and Drug Administration issued a Public Health Notification regarding Unretrieved Device Fragments resulting in harm to patients. The notification stated that they receive around 1,000 reports of incidents involving over 200 surgical products. As stated in the document, the only time reporting is required is if the outcome of the "unretrieved device fragment" due to the use of a poor quality surgical instrument was death or serious injury to the patient.
 
In the 2008 document above, it was noted that there were around 1,000 reports of unretrieved device fragments. An article published in March of 2016 states there are as many as 4,000 incidents of unretrieved device fragments per year in the United States. Obviously, the problem is on the rise. Maybe, just maybe, because the quality of Johnson & Johnson EthicCON surgical tools is on the decline?
 
Even with a United States Food and Drug Administration Class I RECALL due to misfire issues on previous generations of surgical staplers, ETHICON FLEX POWER STAPLER seems to have the same issues as the recalled device. Was this yet another passed through FDA on some fast-track 501K - which means exempt from testing since it was based on an existing device. When the existing device is pulled due to harm to massive numbers of people, do you think newer generations based on the defective item might, uh, just possibly, be required to do the clinical testing required to get it passed through the FDA? Or, is it okay to keep using a device that is based on a previously recalled device - and continue harming people?
 
Another harmful stapler-type device, ETHICON CLIP GUN is also obviously based on the first generation of US FDA Class I RECALLED DEVICE as it also misfires IN PEOPLE during surgery. Sweet, eh?
 
I guess the good news is that lawsuits regarding the recalled Ethicrap stapler are coming in, with at least one already won to the tune of $70 million. Since next generation staplers are based on the first RECALLED stapler defective design, I'm pretty certain there will be a whole lot more victims, a whole lot more lawsuits and a whole lot more healthcare and disability money down the drain to pay for the victims and their injuries.
 
Oh, yet another mesh product RECALLED because it was based on a previously recalled product. Victims piling up for so many things because the corrupt, incompetent and criminally insane run the United States Healthcare System, eh?
 
J&J’s Ethicon recalls Physiomesh flexible composite hernia mesh
 
As the case with all the products in this article, and other products by Johnson & Johnson subsidiary Ethicon, such as MORCELLATORS, not even covered yet, harm by Johnson & Johnson and subsidiary products completely and totally ignored as the bodies pile up...
 
In only the time the site has been online, March of 2012, there were 175 reports filed in MAUDE of DEATH by Johnson & Johnson Ethicon surgical tools. Hope the next Johnson & Johnson Ethicon toe tag isn't on your foot, eh?

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RESOURCES:
1. Securities and Exchange Commission (2016, December 28). Johnson & Johnson Form 10-K, Ex 21 Subsidiaries as of December 28, 2014. Securities and Exchange Commission. Retrieved from https://www.sec.gov/Archives/edgar/data/200406/000020040615000004/ex21-subsidiariesxform10xk.htm
 
2. (February 23, 2016). . . Retrieved from http://www.ethicon.com/healthcare-professionals/products/advanced-energy/harmonic/harmonic-ace-plus
 
3. (February 23, 2016). . . Retrieved from https://www.esutures.com/product/0-in-date/28-ethicon-endo-surgery/144-energy/44573-ethicon-harmonic-ace-shears-5mm-x-36cm-curved-tip-HAR36/
 
4. United States Food and Drug Administration Manufacturer And User Device Experience Database (2016, July 26). . United States Food and Drug Administration Manufacturer And User Device Experience Database. Retrieved from http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=5602941
 
5. United States Food and Drug Administration Manufacturer And User Device Experience Database (2016, July 26). . United States Food and Drug Administration Manufacturer And User Device Experience Database. Retrieved from http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=5496626
 
6. United States Food and Drug Administration Manufacturer And User Device Experience Database (2016, July 26). . United States Food and Drug Administration Manufacturer And User Device Experience Database. Retrieved from http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=4686890
 
7. United States Food and Drug Administration Manufacturer And User Device Experience Database (2016, July 26). . United States Food and Drug Administration Manufacturer And User Device Experience Database. Retrieved from http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=4510148
 
8. United States Food and Drug Administration Manufacturer And User Device Experience Database (2016, July 26). . United States Food and Drug Administration Manufacturer And User Device Experience Database. Retrieved from http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=5350401
 
9. United States Food and Drug Administration Manufacturer And User Device Experience Database (2016, July 26). . United States Food and Drug Administration Manufacturer And User Device Experience Database. Retrieved from http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=5476581
 
10. Daniel G. Schultz, MD, Director, Center for Devices and Radiological Health, Food and Drug Administration (2008, January 15). FDA Public Health Notification: Unretrieved Device Fragments. United States Food and Drug Administration. Retrieved from http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PublicHealthNotifications/ucm062015.htm
 
11. Daly PM, Brophy T, Steatham J, Srodon PD and Birch MJ (2012, December 17). Unretrieved Device Fragments: The clinical risk of using poor quality surgical instruments. CHPSO (Patient Safety Organization). Retrieved from http://www.chpso.org/post/unretrieved-device-fragments
 
12. AHCMedia Contributer (2016, March 1). New problems mean new solutions for retained surgical items. AHCMedia. Retrieved from http://www.ahcmedia.com/articles/137226-new-problems-mean-new-solutions-for-retained-surgical-items
 
13. United States Food and Drug Administration (2012, October 24). Ethicon Endo-Surgery Circular Stapler Sets: Class I Recall - User Difficulty With Firing Stapler Devices. . Retrieved from http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm325965.htm
 
14. United States Food and Drug Administration Manufacturer And User Device Experience Database (2016, July 26). . United States Food and Drug Administration Manufacturer And User Device Experience Database. Retrieved from http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=5675342
 
15. United States Food and Drug Administration Manufacturer And User Device Experience Database (2016, July 26). . United States Food and Drug Administration Manufacturer And User Device Experience Database. Retrieved from http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=5608460
 
16. Visitor Supplied Content (2015, December 14). Alexander Law Group, LLP Wins $70 Million Punitive Judgment Against Johnson & Johnson Subsidiary Ethicon Endo-Surgery. Johnson and Toxin. Retrieved from http://www.johnsonandtoxin.com/alexander_law_ethicon_anal_stapler.shtml
 
17. United States Food and Drug Administration Manufacturer And User Device Experience Database (2016, July 26). . . Retrieved from http://www.massdevice.com/jjs-ethicon-recalls-physiomesh-flexible-composite-hernia-mesh/
 
18. United States Food and Drug Administration Manufacturer And User Device Experience Database (2016, July 26). . . Retrieved from http://www.nytimes.com/2015/05/28/business/fbi-investigates-whether-harm-from-surgical-power-tool-was-ignored.html?_r=0
 
19. United States Food and Drug Administration Manufacturer And User Device Experience Database (2016, July 26). Search Parameters: Manufacturer: Ethicon Event Type: Death Report Date From: 03/01/2012 Report Date To: 06/30/2016. United States Food and Drug Administration Manufacturer And User Device Experience Database. Retrieved from http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/results.cfm?start_search=1&productcode=&productproblem=&devicename=&modelNumber=&reportNumber=&manufacturer=Ethicon&brandname=&eventtype=Death&reportdatefrom=03%2F01%2F2012&reportdateto=06%2F30%2F2016&pagenum=10
 

 

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