ILA 3957Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10884521064607), received between Apr 12, 2018 and Mar 5, 2019 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (5 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 5, 2019Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING SUB-TOTAL GASTRECTOMY PROCEDURE, ON THE SECOND FIRING OF THE DEVICE, THE SURGEON ATTEMPTED TO FIRE THE DEVICE, HOWEVER, THE HANDLE WAS TOO STIFF AND THE DEVICE WAS UNABLE TO FIRE. IT SEEMED THAT THE CARTRIDGE WAS DAMAGED BECAUSE THE TRIGGER WAS PRESSED STRONGLY. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8389761 ↗
• MalfunctionFeb 20, 2019Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING AN OPEN RESECTION OF THE COLON, THE DEVICE DID NOT FIRE. ANOTHER RELOAD WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8355825 ↗
• MalfunctionFeb 19, 2019Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING AN OPEN RESECTION OF THE COLON, THE STAPLER WOULD NOT FIRE. IT WAS STATED THAT THE WHITE PUSHER COULD NOT BE MOVED ON THE RELOAD SO NO STAPLES COULD BE PLACED ON THE TISSUE. ANOTHER LOADING UNIT WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8352183 ↗
• MalfunctionAug 16, 2018Misfire; Misfire

  ACCORDING TO THE REPORTER, DURING SUB TOTAL GASTRECTOMY, THEY USED INSTRUMENT AND THE RELOAD. THE SURGEON STARTED FIRING THE DEVICE, HOWEVER THE FIRING STOPPED AT THE LAST 1CM OF THE LINE. THEY REPLACED BY NEW RELOAD, AND CONNECTED IT TO THE SAME INSTRUMENT ,HOWEVER THEY COULD NOT FIRE THE DEVICE AT ALL. THEN THEY REPLACED BY NEW INSTRUMENT AND ANOTHER NEW RELOAD, AND THE DEVICE WORKED FINE. THE SURGICAL TIME WAS EXTENDED BY LESS THAN 30 MIN. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7788882 ↗
• MalfunctionJul 30, 2018Misfire; Failure to Form Staple; Device Contamination with Chemical or Other Material; Firing Problem; Misfire; Failure to Form Staple; Device Contamination with Chemical or Other Material

  ACCORDING TO THE REPORTER, AT THE FIRST FIRING OF BYPASS OF GASTROENTEROSTOMY, AT JEJUNUM RESECTION (LIFTED-UP JEJUNUM CONSTRUCTION) , THE CARTRIDGE WAS CONNECTED TO THE INSTRUMENT, THEN THE SURGEON STARTED FIRING THE DEVICE, HOWEVER THE KNIFE ADVANCED BY ONLY 1CM THEN THE FIRING STOPPED. THE STAPLES OF THE PROXIMAL END APPEARED FROM THE STAPLE POCKETS, BUT THEY DID NOT FORM . REPLACED BY NEW CARTRIDGE , AND CONNECTED THE SAME INSTRUMENT ,AND THE FIRING WAS SUCCESSFUL. AT THE SAME PROCEDURE ,THE CUSTOMER FOUND A GRAY PLASTIC PIECE WAS ATTACHED TO THE DEVICE. THEY COULD NOT IDENTIFY WHERE THIS FOREIGN MATERIAL CAME FROM. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7732503 ↗
• MalfunctionJun 18, 2018Detachment Of Device Component; Failure to Fire; Detachment Of Device Component; Failure to Fire

  ACCORDING TO THE REPORTER, THEY USED THE DEVICE FOR INTESTINAL CANAL RESECTION AT PROXIMAL PANCREATECTOMY WITH DUODENUM. THEY CONNECTED THE CARTRIDGE TO INSTRUMENT. THE SURGEON CLAMPED THE TISSUE AND PUSHED THE PLASTIC KNOB; HOWEVER, COULD NOT FIRE THE DEVICE. THE SURGEON REMOVED THE DEVICE FROM THE TISSUE AND NOTED THE KNIFE ASSEMBLY DISENGAGED FROM RELOAD. THERE WAS NO PATIENT INJURY. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7610423 ↗
• MalfunctionApr 23, 2018Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, FOR THE THIRD FIRING OF COLECTOMY PROCEDURE, THEY CONNECTED THE CARTRIDGE TO INSTRUMENT; HOWEVER, A WHITE PART OF THE CARTRIDGE WAS UNSTABLE. THEY CONSIDERED THE CARTRIDGE HAD NO PROBLEM AND CONNECTED IT TO THE INSTRUMENT. AT FUNCTIONAL SIDE TO SIDE ANASTOMOSIS, THE SURGEON INSERTED ANVIL FORK AND THE CARTRIDGE FROM SMALL OPENING AT INTESTINAL CANAL, AND THEN CLOSED THE INSTRUMENT. HE TRIED TO FIRE THE DEVICE, HOWEVER HE COULD NOT. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THE STATUS OF THE PATIENT WAS REPORTED AS NO PROBLEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7452534 ↗
• MalfunctionApr 12, 2018Detachment Of Device Component; Difficult or Delayed Positioning; Detachment Of Device Component; Difficult or Delayed Positioning

  ACCORDING TO THE REPORTER, DURING ROUX-EN-Y PROCEDURE, WHILE BEING APPLIED ON JEJUNAL TRANSECTION, THE DEVICE SHOOTS VERY ROUGHLY AND A BULGING OF THE STAPLER WAS NOTED. DURING FIRING, THE DEVICE COMPLETELY FALLEN APART AND THE SURGEON USED FORCE, SO BOTH STAPLERS WERE USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7427298 ↗