Multifire Endo GIA 030811Recalls & reported problems

Summary

The FDA's MAUDE database contains 77 adverse event reports that list this exact device (DI 10884523003789), received between Apr 10, 2017 and Nov 13, 2023 — classified as 16 injuries, 61 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (33 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 77 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 13, 2023Failure to Fire; Detachment of Device or Device Component; Failure to Fire; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, DURING STAPLING OF THE ARTERY, THE HANDLE BLOCKED AND THE SURGEON WAS UNABLE TO FIRE. IT WAS NOTED THAT THE SURGEON WAS ABLE TO SQUEEZE THE HANDLE AND THE HANDLE BROKE OFF. THE PATIENT WAS EXTENDED FOR HOSPITALIZATION BUT NOT DUE TO DEVICE ISSUE. ANOTHER STAPLER WAS USED TO RESOLVE THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18124882 ↗
• MalfunctionNov 13, 2023Failure to Fire; Detachment of Device or Device Component; Failure to Fire; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PANCREATECTOMY PROCEDURE, DURING STAPLING OF THE ARTERY, THE JAWS LOCKED CORRECTLY ON THE ARTERY AND THE SURGEON WAS UNABLE TO FIRE. IT WAS BLOCKED. IT WAS NOTED THAT THE SURGEON WAS ABLE TO SQUEEZE THE HANDLE AND THE HANDLE BROKE OFF. THE PATIENT WAS EXTENDED FOR HOSPITALIZATION BUT NOT DUE TO DEVICE ISSUE. ANOTHER STAPLER WAS USED TO RESOLVE THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18121648 ↗
• InjurySep 24, 2022Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, ON A LAPAROSCOPIC ZENKER'S DIVERTICULUM, DURING TRANSECTION OF THE POUCH, THE DEVICE FIRED BUT THE STAPLES DID NOT DEPLOY PROXIMALLY. THE STAPLE LINE ON THE LEFT SIDE OF THE KNIFE BLADE WAS INCOMPLETE. LASER WAS USED TO SEAL THE OPENING TO FIX THE STAPLE LINE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 15480375 ↗
• MalfunctionJun 11, 2022Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A HYSTERECTOMY AND BOWEL RESECTION PROCEDURE, THE DEVICE WILL CLOSE ONTO TISSUE BUT WOULD NOT TRIGGER FIRING ONTO THE TISSUE. ANOTHER STAPLING DEVICE WAS OPENED TO COMPLETE CASE AND RESOLVE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: Insufficient Information

  MAUDE report 14666433 ↗
• InjuryAug 11, 2021Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER DURING LAPAROSCOPIC OVARIECTOMY, WHILE ON THE ABLATION OF OVARY, THE STAPLER DID NOT FIRE. THE SURGEON ACTIVATES THE FORCEPS TO PLACE THE STAPLES, NOTHING HAPPENS. THE ACTION IS REPEATED AGAIN BUT STILL NO STAPLES. AS A RESULT, THE PATIENT EXPERIENCED RED PINCHING ON THE OVARY AND TISSUE DAMAGE. TO RESOLVE THE ISSUE, A NEW HANDLE AND RELOAD WAS USED BY THE SURGEON TO COMPLETE THE CASE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 12309198 ↗
• InjuryJun 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING OPEN NEPHRECTOMY, WHEN DIVIDING THE RENAL VEIN AND RENAL ARTERY, AND TAKING AWAY THE KIDNEY, THE STAPLE LINE WAS FOUND BLEEDING AND THE PATIENT LOST 500 CC OF BLOOD. TO RESOLVE THE BLEEDING, THE VASCULAR SURGEON USED SUTURE TO CLOSE THE VESSEL AND BLOOD TRANSFUSION WAS GIVEN TO THE PATIENT. DUE TO DEVICE MALFUNCTION, THE SURGICAL PROCEDURE WAS EXTENDED FOR MORE THAN 30 MINUTES.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Unspecified Tissue Injury

  MAUDE report 11958678 ↗
• MalfunctionFeb 9, 2021Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, WHEN THE SURGEON TRIED TO SQUEEZE THE HANDLE TO STAPLE, THE SPRING DETAC HED/DROPPED WHEN OPENING THE JAWS RENDERING IT UNUSABLE. ANOTHER STAPLER WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11300134 ↗
• MalfunctionNov 5, 2020Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING LARYNGEAL POUCH PROCEDURE, THE DEVICE DID NOT FIRE. THE SURGEON COULD NOT SQUEEZE THE HANDLE TO FIRE IT AS IT FELT BLOCKED AND HE DID NOT WANT TO USE TOO MUCH FORCE. 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; No Consequences Or Impact To Patient

  MAUDE report 10795405 ↗
• MalfunctionOct 26, 2020Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING REMOVAL OF KIDNEY ON A LAPAROSCOPIC DONOR NEPHRECTOMY, THE DEVICE DID NOT FIRE. ANOTHER DEVICE WAS USED 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 10733228 ↗
• MalfunctionSep 3, 2020Failure to Fire; Noise, Audible; Failure to Fire; Noise, Audible

  ACCORDING TO THE REPORTER, DURING STAPLING OF THE PHARYNGEAL POUCH, WHEN THE SURGEON PLACED THE DEVICE ON THE POUCH AND CLIPPED DOWN TO SQUEEZE THE HANDLE, THERE WAS RESISTANCE FELT AND A LOUD CRUNCHING / GRINDING NOISE WAS HEARD AND THE GUN WOULD NOT RELEASE EASILY, BUT THE GUN FAILED TO STAPLE OR CUT. THE GUN WAS REMOVED AND THERE WERE NO VISIBLE STAPLES WERE IN THE PATIENT BUT THE USER COULD SEE INDENTATION; NOT TISSUE DAMAGE, JUST WHERE THE TISSUE HAD VISIBLY BEEN COMPRESSED FROM TRYING TO FIRE THE FIRST STAPLER. A NEW HANDLE WAS OPENED TO RESOLVE THE ISSUE IN ORDER 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 10490727 ↗
• MalfunctionAug 27, 2020Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC RESECTION OF AN APPENDIX, THE SURGEON COULD NOT SQUEEZE THE HANDLE. HENCE, THE STAPLER WOULD 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 10460481 ↗
• MalfunctionApr 6, 2020Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC APPENDECTOMY, THE DEVICE DID NOT FIRE. A NEW DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9927752 ↗
• MalfunctionFeb 13, 2020Retraction Problem; Retraction Problem

  ACCORDING TO THE REPORTER, DURING A LIVER TRANSPLANT, ON THE ARTERY, THE STAPLER WAS ABLE TO FIRE, THE KNIFE WAS STUCK, AND HAS NOT RETURNED TO ITS PROTECTIVE SHEATH. NOTHING WAS DONE TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9708025 ↗
• MalfunctionNov 25, 2019Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING SARCOMA RESECTION, THE DEVICE WAS PLACED ACROSS A BUNDLE OF TISSUE TO BE TRANSECTED. ONCE THE DEVICE WAS CLOSED, AN ATTEMPT WAS MADE TO FIRE, AND THE HANDLE OR FIRING DID NOT ADVANCE. THE DEVICE WAS CHECKED, UNLOADED AND RELOADED BY THE SCRUB NURSE, BUT DEVICE DID NOT FIRE. A NEW STAPLER WAS OPENED AND USED WITHOUT TROUBLE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9372260 ↗
• MalfunctionNov 7, 2019Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, THE STAPLER WAS BLOCKED AND UNABLE TO FIRE. THE SURGEON WAS UNABLE TO SQUEEZE THE HANDLE. CHANGED THE STAPLER TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9292548 ↗
• MalfunctionOct 11, 2019Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, ON A LAPAROSCOPIC APPENDECTOMY, AT THE START OF THE PROCEDURE, 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 9180697 ↗
• MalfunctionOct 8, 2019Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC APPENDECTOMY, 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 9166472 ↗
• MalfunctionAug 19, 2019Entrapment of Device; Entrapment of Device

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE DEVICE WOULD NOT OPEN UNTIL FORCED, AND THE LOAD WAS NOTED TO BE DISFIGURED AND BENT.

  Patient problems: No Information

  MAUDE report 8905034 ↗
• MalfunctionMay 15, 2019Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING THE LIGATION OF VESSELS ON A HEPATECTOMY PROCEDURE, THE STAPLER DID NOT FIRE. A NEW DEVICE WAS USED WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8614059 ↗
• MalfunctionApr 26, 2019Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, WHEN STAPLING THE TISSUE, THE STAPLER WOULD NOT FIRE ON THE THIRD FIRING. OPENED ANOTHER MULTI-FIRE HANDLE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8554789 ↗
• MalfunctionMar 23, 2019Break; Break

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC APPENDECTOMY PROCEDURE, THE LOAD ON THE STAPLER FELL APART INTO 3 PIECES WHEN THE TECH REMOVED THE SHIPPING WEDGE. THE DEVICE NEVER CAME IN CONTACT WITH PATIENT. ANOTHER STAPLER WAS OPENED AND THE PROCEDURE WAS COMPLETED WITHOUT ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8446564 ↗
• MalfunctionMar 19, 2019Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE DEVICE DID NOT CLICK WHEN FIRED. THE DEVICE WAS NOT ABLE TO FIRE. THEY HAD TO OPEN ANOTHER DEVICE TO FINISH THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8432144 ↗
• MalfunctionMar 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THE DEVICE WAS RETURN WITHOUT ANY ACCOMPANYING INFORMATION. THE DEVICE FOUND THAT TE APPROXIMATING LEVER WAS BROKEN AT THE BASE IN A MANNER CONSISTENT WITH EXPOSURE TO EXCESS CLAMPING FORCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8423242 ↗
• InjuryJan 31, 2019Mechanics Altered; Mechanics Altered

  ACCORDING TO THE REPORTER, DURING RIGHT HEPATIC LOBECTOMY, THE STAPLER CUT BUT DID NOT FIRE. IT WAS REPORTED THE SURGEON ABLE TO SQUEEZED THE HANDLE. NO STAPLES VISIBLE ON RIGHT HEPATIC VEIN OR INFERIOR VENA CAVA. THEY SEEMED TO BE SOME STAPLES LEFT IN THE CARTRIDGE. IT WAS NOTED THE PATIENT HAD BLOOD LOSS OF 500ML OR MORE DUE TO THE PRODUCT ISSUE. THE PATIENT HAD BLOOD TRANSFUSION OF 8 UNITS OF BLOOD AND 2500CC OF CELL-SAVER, THE SURGICAL TIME EXTENDED 30 MINUTES OR MORE AND THE PATIENT HAD EXTENDED HOSPITALIZATION STAY OF 10 DAYS.

  Patient problems: Blood Loss; No Code Available

  MAUDE report 8294792 ↗
• MalfunctionJan 4, 2019Mechanics Altered; Mechanics Altered

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC ZENKER'S DIVERTICULUM PROCEDURE, WHILE FIRING THE STAPLER ON THE POUCH, THE RELOAD CUT TISSUE, BUT DID NOT DEPLOY ANY STAPLES. ADDITIONAL RELOADS WERE OPENED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8219958 ↗