Pasadena medical device defect attorneys: Ethicon Endo-Surgery, a subsidiary of Johnson & Johnson, issued a worldwide recall of more than 500 lots of its Proximate surgical staplers and accessories for the medical devices. The global recall also affects certain lots of Ethicon’s HCS hemorrhoidal circular staplers and accessories.
The Ethicon Proximate surgical stapler recall, being conducted with the knowledge of the U.S. FDA, is due to performance defects that could cause the devices to misfire. The medical device defect could result in difficulty in firing the medical devices. This difficulty could result in incomplete firing strokes and incomplete staple formation.
Our Pasadena medical device defect attorneys point out that improper staple to tissue interaction can result in tissue creep, ischemia, tearing of the tissue, strictures, inadequate staple formation, and/or staple-line leaks, Anastomotic leaks could cause peritonitis, septic shock, multi-organ failure, and even death.
Ethicon Endo-Surgery says it working to isolate the problems that led to the defect so that the company can resume production of the Proximate surgical staplers and HCS hemorrhoidal circular staplers and accessories. The FDA’s adverse event reporting system database contains dozens of reports relating to problems with the Proximate stapler. Many of these are from May and June.
One May report stated that the surgeon could not squeeze the firing trigger and opened the medical device to find staples that were only partially fired. The Ethicon company received that particular stapler back for analysis. The analysis indicated that the stapler might not have been fired through a full firing stroke or possibly that the indicator had not moved fully into the safe green firing range. Ethicon said that it tested that stapler and was able to fire it without incident.
Our Pasadena medical device defect attorneys note that firing a tissue stapler is considerably more complicated than firing the stapler you might use to stick your documents together. Different tissue thicknesses and types require different staple cartridges and sizes. Tissue must be compressed for a time before the staple is fired in order to release excess liquid from the tissue and ensure the integrity of the stapler line.
If you’ve suffered injury or lost a loved one because of inadequate stapling of tissue during surgery, let us know. Call or contact us online for a free consultation and case evaluation. Our experienced Pasadena medical device defect attorneys have more than 14 years of experience investigating medical device injury and fatality cases. Our sound advice could provide you and your family with the key information you need to learn how to hold the manufacturer accountable and obtain a full financial recovery for the losses you’ve suffered due to the device defect.