ILA 3948LRecalls & reported problems

Summary

The FDA's MAUDE database contains 54 adverse event reports that list this exact device (DI 10884521063150), received between Aug 2, 2017 and Jun 17, 2020 — classified as 2 injuries, 52 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (35 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 54 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 17, 2020Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING COLON SURGERY, WHEN ON A FUNCTIONAL SIDE-TO-SIDE ANASTOMOSIS, THE DEVICE WAS UNABLE TO BE FIRED. WHEN A NEW CARTRIDGE WAS ATTACHED, IT WAS ABLE TO BE FIRED WITHOUT PROBLEM. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10163271 ↗
• MalfunctionMay 13, 2020Failure to Cut; Failure to Cut

  ACCORDING TO THE REPORTER, DURING COLECTOMY, THE STAPLE WAS FIRED, BUT THE TISSUE WAS NOTED NOT BEING CUT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10050273 ↗
• InjuryApr 5, 2020Product Quality Problem; Failure to Fire; Product Quality Problem; Failure to Fire

  ACCORDING TO THE REPORTER, DURING COLECTOMY, THE RELOAD WAS SEEN TO BE CURVED THAT MADE THE KNIFE UNABLE TO SLIDE AND BLOCKED. THE PROCEDURE WAS CONVERTED TO OPEN COLECTOMY.

  Patient problems: No Code Available; Tissue Damage

  MAUDE report 9927095 ↗
• MalfunctionJan 20, 2020Failure to Cut; Material Twisted/Bent; Failure to Cut; Material Twisted/Bent

  ACCORDING TO THE REPORTER, DURING PROXIMAL GASTRECTOMY, WHEN USING THE LOADING UNIT, IT WAS TOO STIFF AND THE KNIFE DID NOT MOVE. THE SURGEON TRIED TO FIRE ON NOTHING WITHOUT TISSUE CLAMPED, BUT THE KNIFE STILL DID NOT MOVE AT ALL. WHEN USING ANOTHER LOADING UNIT, THE KNIFE BENT AND COULD NOT CUT AT ALL HOWEVER, THE STAPLES HAVE BEEN PROPERLY FORMED UNTIL THE END. THEY WERE NOT ABLE TO CUT WITH THE KNIFE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9607256 ↗
• MalfunctionDec 6, 2019Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, ON A COLECTOMY END-TO-END ANASTOMOSIS, DURING THE FIRST FIRING, DESPITE OPERATING THE KNOB, THE KNOB DID NOT MOVE FORWARD AND THE DEVICE COULD NOT FIRE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9424908 ↗
• MalfunctionOct 28, 2019Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A SMALL INTESTINE RESECTION PROCEDURE, WHILE USING THE DEVICE FOR SMALL INTESTINE RESECTION, BUT THE FIRING KNOB DID NOT MOVE FORWARD. THE DEVICE WAS ABLE TO BE FIRED AFTER THE RELOAD WAS REPLACED WITH A NEW ONE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9247894 ↗
• MalfunctionSep 12, 2019Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, AT THE FIRST FIRING DURING A PROXIMAL PANCREATICODUODENECTOMY, AN ATTEMPT WAS MADE TO ADVANCE THE KNOB TO PERFORM FIRING, BUT THE KNOB DID NOT ADVANCE, AND FIRING WAS UNAVAILABLE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9007153 ↗
• MalfunctionAug 27, 2019Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC RIGHT HEMICOLECTOMY PROCEDURE, AT THE FIRST FIRING, THE DEVICE WAS SET TO THE TISSUE AND WAS ATTEMPTED TO BE FIRED, THE KNOB ADVANCED BUT IT DID NOT WORK. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8934792 ↗
• MalfunctionJul 8, 2019Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING ILEAL RESECTION IN A LAPAROSCOPIC JEJUNOILEAL BYPASS PROCEDURE, THE PLASTIC KNOB COULD NOT BE ADVANCED, AND THE DEVICE COULD NOT BE FIRED. A NEW CARTRIDGE WAS TAKEN OUT AND THE DEVICE WAS ABLE TO BE FIRED WITHOUT PROBLEM. THE STATUS OF THE PATIENT WAS REPORTED AS NO PROBLEM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8769127 ↗
• MalfunctionJul 2, 2019Break; Retraction Problem; Break; Retraction Problem

  ACCORDING TO THE REPORTER, DURING A COLECTOMY END TO END ANASTOMOSIS WHILE RESECTING THE COLON, THE DEVICE BROKE APART WHEN SQUEEZING THE LEVER TO RETURN THE KNIFE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8756247 ↗
• MalfunctionJun 14, 2019Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING PROXIMAL PANCREATICODUODENECTOMY, WHEN TRYING TO FIRE AFTER SETTING THE CARTRIDGE ON THE TISSUE, THE KNIFE AND THE CARTRIDGE PART FELL APART. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8701876 ↗
• MalfunctionMay 14, 2019Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LPROXIMAL PANCREATICODUODENECTOMY, DURING THE FIRST FIRING, WHEN FIRING THE PRODUCT, IT GOT LOCKED, AND THE KNIFE WAS UNABLE TO BE ADVANCED. THE EVENT OCCURRED DURING THE PROCEDURE BUT THE PRODUCT WAS NOT USED FOR PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8610229 ↗
• MalfunctionMay 12, 2019Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING COLECTOMY PROCEDURE, AFTER SETTING ONTO THE TISSUE, AN ATTEMPT WAS MADE TO ADVANCE THE FIRING KNOB, BUT IT WAS STIFF AND FIRING COULD NOT BE PERFORMED. THEY THEN USED ANOTHER DEVICE TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE.

  Patient problems: No Information

  MAUDE report 8602429 ↗
• MalfunctionApr 18, 2019Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A PROXIMAL PANCREATICODUODENECTOMY PROCEDURE, ON THE FIRST FIRING, WHEN THE SURGEON TRIED TO FIRE THE DEVICE AFTER SETTING THE DEVICE ONTO THE TISSUE, THE LEVER DID NOT ADVANCE AND THE DEVICE COULD NOT FIRE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8528119 ↗
• MalfunctionMar 11, 2019Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING DISTAL PANCREATECTOMY, ON THE SECOND FIRING, THE STAPLING DID NOT ADVANCE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8409488 ↗
• MalfunctionMar 5, 2019Difficult or Delayed Positioning; Difficult or Delayed Positioning

  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 8389789 ↗
• 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 8355751 ↗
• 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 8352189 ↗
• MalfunctionNov 15, 2018Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER IN A COLECTOMY DURING A FUNCTIONAL END TO END ANASTOMOSIS, ON THE 2ND FIRING, WHILE THE SURGEON USED THE CARTRIDGE ON RESECTION OF THE ANAL SIDE COLON, THE SURGEON WAS UNABLE TO FIRE AFTER CLAMPING THE TISSUE. A NEW CARTRIDGE WAS OPENED AND USED. THE SURGICAL TIME WAS EXTENDED BY LESS THAN 30 MIN. THERE WAS NO PATIENT HARM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8074134 ↗
• MalfunctionNov 5, 2018Break; Expulsion; Break; Expulsion

  ACCORDING TO THE REPORTER, DURING A SIGMOIDECTOMY PROCEDURE, ON THE FIRST FIRING WHEN THE SURGEON APPROACHED TO THE COLON AND TRIED TO FIRE THE DEVICE RELOAD GOT APART, IN ADDITION THE OTHER RELOAD PRE-FIRED DURING STORAGE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8038575 ↗
• MalfunctionSep 18, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING BRICKER PROCEDURE ON URO-ONCOLOGY, THE DEVICE FELL OUT. THE STAPLERS WERE NOT ON THE CORRECT PLACE AND WERE DISLOCATED. THE EVENT HAPPEN DURING THE PROCEDURE BUT THE DEVICE WAS NOT USED IN PATIENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7886647 ↗
• MalfunctionAug 27, 2018Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING TOTAL GASTRECTOMY, THE SURGEON CONNECTED THE RELOAD TO THE INSTRUMENT AND THE SURGEON CLAMPED THE DUODENUM AND TRIED TO FIRE THE DEVICE HOWEVER THE KNIFE DID NOT ADVANCE. REPLACED BY A NEW RELOAD AND THE FIRING WAS COMPLETED. THE SURGICAL TIME WAS EXTENDED BY LESS THAN 30 MINUTES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7818293 ↗
• InjuryAug 22, 2018Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A DISTAL GASTRECTOMY, THEY SET THE ANVIL TO THE ANVIL FORK, AND THE SURGEON CLAMPED THE DUODENUM AND TRIED TO FIRE THE DEVICE, HOWEVER, THE KNIFE DID NOT ADVANCE. REPLACED BY A NEW RELOAD, AND THE FIRING WAS COMPLETED. REOPERATION WAS REQUIRED DUE TO THE ISSUE. THE SURGICAL TIME WAS EXTENDED BY LESS THAN 30 MIN.

  Patient problems: No Code Available

  MAUDE report 7805213 ↗
• 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 7789767 ↗
• MalfunctionAug 6, 2018Defective Device; Material Twisted/Bent; Material Twisted/Bent

  ACCORDING TO THE REPORTER, DURING THE FIRST FIRING OF COLECTOMY, THEY TRIED TO SET THE ANVIL TO THE INSTRUMENT, HOWEVER, THEY FOUND OUT THAT THE ANVIL WAS DISTORTED. THEY REPLACE THE RELOAD AND THE PROCEDURE WAS COMPLETED. NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7752392 ↗