The medical device company issued a global recall of certain lots of its Proximate PPH and HCS hemorrhoidal circular staplers and accessories "due to difficulty firing the device which may result in incomplete firing stroke, that may result in an incomplete staple formation," according to the recall report.
"The voluntary recall is being conducted with the full knowledge of the U.S. Food and Drug Administration," according to the report. "We are working to implement actions to resume production."
Ethicon asked that healthcare providers return all affected products by November 5 in order to receive a credit. Ethicon did not respond to requests for comment.
The recall notice hasn’t yet been filed on the FDA website, but the federal watchdog agency’s MAUDE adverse event reporting system contains dozens of incidents related to the Proximate stapler. There are 8 incidents reported for June alone, though not all appear related to the firing issue noted in the recall.
A report filed May 21 stated that "during a procedure for prolapse and hemorrhoids device was very hard to fire."
In a separate report filed May 18 the company noted that a "surgeon was not able to squeeze the firing trigger" during a procedure, and that "the surgeon subsequently opened the stapler to find staples partially ‘fired’."
Ethicon received the device back for analysis with the staples present and the device’s breakaway washer "uncut and indented, indicating that the device had not been fired through a full firing stroke or possibly that the orange indicator was not fully into the safe green firing range," according to the report.
The company tested the returned Proximate device and was able to fire the instrument "without incident."