Multifire Endo GIA 030813Recalls & reported problems

Summary

The FDA's MAUDE database contains 71 adverse event reports that list this exact device (DI 10884523003796), received between May 4, 2017 and Sep 14, 2022 — classified as 1 death, 6 injuries, 64 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (31 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 71 reports, in the reporter's own words as published by the FDA.

• InjurySep 14, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, EVEN WITHOUT EXCESSIVE FORCE, THE PRE-LOADED RELOAD BROKE APART WHILE IN USE INSIDE THE PATIENT¿S ABDOMINAL AREA LAPAROSCOPICALLY WHEN THE SURGEON WAS READY TO STAPLE. THE STAPLING CARTRIDGE WAS DETACHED FROM THE STAPLER¿S SHEATH COMPLETELY. THE DEVICE PARTS WERE RETRIEVED. NO BROKEN STAPLING PARTS WERE FOUND UPON INITIAL ASSESSMENT AND POST-OPERATIVE X-RAY IMAGING OF THE DIAPHRAGM AND ABDOMINAL REGIONS.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 15420136 ↗
• MalfunctionApr 28, 2022Failure to Fire; Human-Device Interface Problem; Failure to Fire; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC APPENDECTOMY, WHILE AT BASE OF CECUM, THE DEVICE DID NOT FIRE. WHEN UNLOADING, THE DEVICE DID NOT RELEASE THE CLAMPS. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14230057 ↗
• MalfunctionJul 8, 2021Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC APPENDECTOMY, THE DEVICE COULD NOT BE FIRE. THE SURGEON THEN USED ANOTHER DEVICE TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12137850 ↗
• MalfunctionMay 5, 2021Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC RESECTION OF THE APPENDIX, THE JAWS COULD NOT BE OPEN. ANOTHER DEVICE WAS USED TO COM PLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11776753 ↗
• MalfunctionMay 3, 2021Misfire; Misfire

  ACCORDING TO THE REPORTER, THE DEVICE FIRED INCORRECTLY.

  Patient problems: Insufficient Information

  MAUDE report 11766814 ↗
• MalfunctionDec 30, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC APPENDECTOMY, SMALL BLUE PLASTIC PART FROM THE RELOAD BROKE AND FELL INTO THE CAVITY. THE SAID PART WAS RETRIEVED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11094440 ↗
• MalfunctionDec 18, 2020Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, ON A LAPAROSCOPIC CHOLECYSTECTOMY, WHILE STAPLING THE CYSTIC DUCT, THE SURGEON PLACED THE DEVICE AND WAS THEN UNABLE TO SQUEEZE THE HANDLE TO FIRE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11037808 ↗
• MalfunctionNov 12, 2020Entrapment of Device; Entrapment of Device

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC APPENDECTOMY, THE JAWS OF THE DEVICE LOCKED ON TISSUE. THE DEVICE WAS ALSO NOT FIRED. STAPLE WAS CHANGED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10832870 ↗
• InjurySep 18, 2020Mechanics Altered; Mechanics Altered

  ACCORDING TO THE REPORTER, DURING TRANSECTION OF DIVERTICULUM IN A TRANSORAL ZENKER'S DIVERTICULOTOMY, AFTER SURGEON FIRED STAPLER, STAPLES DID NOT GO INTO THE TISSUE. WHEN HE PULLED THE STAPLER OUT THERE WERE STAPLES ON THE CARTRIDGE. IT WAS NOTED THAT THERE WAS UNANTICIPATED TISSUE LOSS AS A RESULT OF THIS PROBLEM. SURGEON UTILIZED A SECOND STAPLE RELOAD.

  Patient problems: Tissue Damage; Unspecified Tissue Injury

  MAUDE report 10552328 ↗
• MalfunctionAug 21, 2020Entrapment of Device; Failure to Form Staple; Human-Device Interface Problem; Entrapment of Device; Failure to Form Staple; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, DURING AN OPEN LIVER RESECTION, THERE WAS A MALFORMATION AT THE STAPLE LINE AND IT WAS INCOMPLETE AT THE CENTRAL PART. THE JAWS OF THE DEVICE LOCKED ON TISSUE BUT WAS REMOVED STRONGLY. THE RELOAD WAS ALSO DIFFICULT TO UNLOAD SO A NEW DEVICE WAS USED TO RESOLVE THE ISSUE AND COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10439957 ↗
• MalfunctionJul 27, 2020Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC APPENDECTOMY PROCEDURE, THE SURGEON CLOSED THE STAPLER AT THE APPENDIX AND STARTED THE FIRING; HOWEVER, THE FIRING WAS WITH STRENGTH AND WHEN THE SURGEON OPENED THE DEVICE, THE STAPLES WERE NOT FIRED AND TISSUE WAS NOT CUT. THE SURGEON THEN USED ANOTHER DEVICE LOADING UNIT TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10325248 ↗
• MalfunctionJul 16, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE APPENDIX WAS CAREFULLY DELIMITED AND MOBILIZED WITH A HOOK. WHEN THE TEAM WAS ABOUT TO FIRE THE DEVICE, THE TEAM HAD A DISCUSSION WHO WILL FIRE THE DEVICE. WHEN IT WAS DECIDED AND WHEN THEY PULLED THE STAPLER OUT OF THE PORT, THE USER GOT AN OPEN STAPLER THAT THE RELOAD WAS MISSING. IT WAS REPORTED THAT THE RELOAD WAS IN THE PATIENT AND THE USER INCREASED 5 MM PORT TO 12 MM PORT FOR THE RELOAD TO BE RETRIEVED AND WAS PLACED IN A BAG. NO INTESTINAL DAMAGE WAS NOTICED. THE SURGEON USED ANOTHER STAPLER TO RESOLVE THE ISSUE. THE DEVICE WAS PLACED IN A SECOND BAG. BOTH BAGS WERE TAKEN OUT OF THE UMBILICAL GATE. SURGEON OBSERVED MINOR BLEEDING THAT HAS BEEN STOPPED WITH A NAPKIN. NO FURTHER PATIENT COMPLICATION REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10283352 ↗
• MalfunctionJun 29, 2020Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC APPENDECTOMY PROCEDURE, THE RELOAD BROKE OFF PRIOR TO FIRING AND FELL INTO THE PATIENT'S CAVITY. IT WAS RETRIEVED THROUGH TROCAR PORTS. ANOTHER STAPLER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10205947 ↗
• MalfunctionMay 11, 2020Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING LIVER RESECTION, THE SURGEON COULD NOT FIRE THE DEVICE. SURGEON USED ANOTHER INSTRUMENT TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10042862 ↗
• InjuryApr 2, 2020Failure to Fire; Mechanics Altered; Failure to Fire; Mechanics Altered

  ACCORDING TO THE REPORTER, DURING AN ENDOSCOPIC PHARYNGEAL PROCEDURE, WHEN THE SURGEON TRIED TO FIRE, THE DEVICE CUT BUT NONE OF THE STAPLES WERE FIRED. TO RESOLVE THE ISSUE SURGEON NEED TO PERFORM ADDITIONAL OPERATION TO REPAIR THE IATROGENIC ESOPHAGEAL PERFORATION OF THE PATIENT, AND THE PATIENT HOSPITALIZATION WAS EXTENDED DUE TO THE DEVICE PROBLEM.

  Patient problems: No Code Available; Perforation of Esophagus; Tissue Damage

  MAUDE report 9915845 ↗
• MalfunctionMar 27, 2020Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC NEPHRECTOMY, THE DEVICE DID 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 9890697 ↗
• MalfunctionMar 17, 2020Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING RESECTION OF APPENDIX ON A LAPAROSCOPIC APPENDECTOMY, THE STAPLER WAS ABLE TO FIRE HOWEVER A BLUE PLASTIC COMPONENT BROKE OFF AND FELL INTO THE PATIENT¿S CAVITY. THE COMPONENT WAS RETRIEVED WITH A GRASPER THROUGH THE CANNULA. THERE WAS NO PATIENT INJURY

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9843487 ↗
• MalfunctionFeb 20, 2020Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, WHEN STAPLING THE APPENDIX DURING A LAPAROSCOPIC APPENDECTOMY, THE STAPLER BLOCKED AND DID NOT FIRE. ANOTHER STAPLER WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9733591 ↗
• MalfunctionFeb 6, 2020Failure to Cut; Failure to Cut

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC APPENDECTOMY PROCEDURE, THE DEVICE STAPLED BUT DID NOT CUT. ANOTHER DEVICE WAS USED TO CUT THE TISSUE BETWEEN THE STAPLE LINES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9677429 ↗
• MalfunctionFeb 6, 2020Failure to Cut; Failure to Cut

  ACCORDING TO THE REPORTER, WHEN STAPLING THE APPENDIX DURING LAPAROSCOPIC APPENDECTOMY, THE DEVICE STAPLED BUT DID NOT CUT. ANOTHER DEVICE WAS USED TO CUT THE TISSUE BETWEEN THE STAPLE LINES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9676538 ↗
• MalfunctionJan 31, 2020Failure to Cut; Failure to Cut

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC CHOLECYSTECTOMY, DURING BILIARY DUCT TRANSECTION, THE STAPLER WAS FIRED AND IT LAID DOWN THE STAPLES BUT DID NOT CUT. SURGEON USED LAPAROSCOPIC SCISSOR TO CUT THE TISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Information

  MAUDE report 9654725 ↗
• MalfunctionJan 21, 2020Failure to Cut; Failure to Cut

  ACCORDING TO THE REPORTER, ON A LAPAROSCOPIC APPENDECTOMY, DURING STAPLING, THE STAPLES WERE DEPLOYED BUT THE KNIFE DID NOT CUT. ANOTHER RELOAD WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9610271 ↗
• MalfunctionDec 17, 2019Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC APPENDECTOMY, THE SURGEON COULD NOT FIRE THE INSTRUMENT. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9483012 ↗
• MalfunctionDec 5, 2019Failure to Cut; Failure to Cut

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC APPENDECTOMY, THE STAPLERS WERE DEPLOYED BUT THERE WAS NO ACTION OF THE KNIFE. THE SURGEON NOTED THAT THE DEVICE WAS GIVEN BY THE SCRUB NURSE WITH THE SECURITY ALREADY RELEASED RESULTED IN MISFIRING AND BY MANIPULATION A BLOCKAGE OF THE STAPLER. THE SURGEON USED SCISSORS TO CUT THE TISSUE AND USED MANUAL STAPLER TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9419075 ↗
• MalfunctionNov 6, 2019Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, WHILE BEING APPLIED TO APPENDIX DURING LAPAROSCOPIC APPENDECTOMY, THE DEVICE WAS UNABLE TO FIRE. THE SURGEON TOOK ANOTHER DEVICE TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9287397 ↗