A surgical stapler in use during August and September has been recalled after being connected to one death and seven injuries.
Ethicon pulled 8,256 of its Echelon Flex Endopath staplers because, as the FDA-posted recall notice says, an “out of specification component within the jaw of the device” can leave staples not completely formed. That’s as serious a problem as it sounds, even for a stapler used in open or minimally invasive surgeries.
“If a problem with the staple line is not recognized or is not adequately addressed,” the notice states, “there is a potential risk of prolonged surgery, postoperative connection (anastomotic) leak, hemorrhage, hemorrhagic shock, additional surgical intervention, or death.”
And these staplers were linked to that one death and seven injuries before Ethicon began recalling them on Oct. 3. They were distributed from Aug. 1 through Sept. 26. People who have had open or lightly invasive surgeries in the last two months or will be having surgery soon should ask their doctors what kind of stapler was or will be used.
The four kinds of Echelon Flex Endopath staplers recalled:
▪ Flex 60 Endopath Stapler, Articulating Endoscopic Linear Cutter, product code EC60A, lot Nos. T9408M and T94A9Z.
▪ Flex 60 Powered Plus Compact Articulating Endoscopic Linear Cutter, product code PCEE60A, lot Nos. T93Z9Y and T9411A.
▪ Flex 60 Powered Plus Articulating Endoscopic Linear Cutter, 44cm Shaft Length, product code PLEE60A, lot Nos. T93X95; T93Z75; T93Z2W; T9413Z; T93Z1G; T93Y4M; T94045; T94117; T93X17; T94087; T93Z2X; T9405L; and T94253.
▪ Flex 60 Powered Plus Articulating Endoscopic Linear Cutter, 34cm Shaft Length, product code PSEE60A, lot Nos. T93Z5W; T93Z5X; T9405V; T9405W; T93Z3F; T9401L; T93Y8X; T94008; T9400D; T93Z5R.
Anyone with questions can call 877-384-4266, Monday through Friday, 8 a.m. to 6 p.m., Eastern time.
In April, Ethicon, a Johnson & Johnson company, had to recall 92,486 curved staplers used in gastrointestinal surgeries for “insufficient firing and failure to completely form staples.”