Multifire Endo TA 010901Recalls & reported problems

Summary

The FDA's MAUDE database contains 102 adverse event reports that list this exact device (DI 10884521047747), received between Apr 7, 2017 and Sep 19, 2025 — classified as 22 injuries, 80 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (36 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 25 most recent of 102 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 19, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT PRIOR TO USE, THE MULTIFIRE STAPLER BROKE AT THE HANDLE. THE BROKEN PART DISENGAGED, BUT NO PIECES FELL INTO THE PATIENT CAVITY. THE DEVICE WAS REPLACED WITH A NEW HANDLE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23101176 ↗
• MalfunctionJul 4, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC NEPHRECTOMY PROCEDURE, THE STAPLER WOULD NOT FIRE AFTER THE RELOAD WAS CHANGED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19675236 ↗
• MalfunctionJun 24, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A KIDNEY TRANSPLANT PROCEDURE, THE STAPLER WAS UNABLE TO FIRE. A NEW RELOAD WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19594829 ↗
• MalfunctionJan 31, 2024Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, PRIOR TO USE OF THE DEVICE IN A PROCEDURE, THE TRIGGER TO FIRE THE STAPLER WAS UNABLE TO BE ENGAGED, THE STAPLER WAS LOCKED IN THE OPEN POSITION, THE STAPLER DID NOT CLOSE TOGETHER WHEN TRIALED BEFORE USE IN THE PATIENT. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18617093 ↗
• MalfunctionNov 21, 2023Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC LIVING DONOR NEPHRECTOMY PROCEDURE, AT THE TIME OF BLOOD VESSEL RESECTION, THE HANDLE COULD NOT BE SQUEEZED. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18185735 ↗
• MalfunctionJul 31, 2023Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING AN OPEN KIDNEY TRANSPLANT, WHILE STAPLING ON THE VESSEL, THE STAPLER WAS NOT ABLE TO FIRE. A NEW STAPLER WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17426012 ↗
• InjurySep 30, 2022Entrapment of Device; Failure to Form Staple; Adverse Event Without Identified Device or Use Problem; Entrapment of Device; Failure to Form Staple; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC DONOR NEPHRECTOMY, WHILE SEPARATING THE RENAL ARTERY AND RENAL VEIN, THE TISSUE DID NOT COME OFF FROM THE CARTRIDGE WHEN THE JAW WAS OPENED AFTER FIRING; IT DID NOT COME OFF WHEN AN ATTEMPT WAS MADE TO REMOVE IT USING FORCEPS, THE JAW OF DEVICE WAS FIXATED TO TISSUE. AN ADDITIONAL SEPARATION WAS ATTEMPTED USING POWERED STAPLER FROM THE PLANNED RESECTION POSITION DURING RENAL VEIN SEPARATION, HOWEVER, THE ALREADY BITTEN DEVICE DID NOT WORK OUT WELL DUE TO INTERFERENCE. THE STAPLE THAT WAS LEFT IN THE CARTRIDGE FORK IS NOT A CLEAN B-TYPE. TO RESOLVE THE ISSUE AND COMPLETE THE CASE, EMERGENCY TRANSITION FROM LAPAROSCOPIC SURGERY TO LAPAROTOMY WAS DONE AND THE INCISION WAS EXPANDED WIDER THAN EXPECTED, EXCEEDED 1 INCH (2.54 CM), THE BLOOD VESSEL WAS SUTURED WITH A NEEDLE SUTURE, THEN CUT WITH A SCALPEL THEN COLLECT THE TISSUE AND THE CARTRIDGE, AND THE SURGERY TIME WAS EXTENDED BY 30 MINUTES OR MORE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 15512657 ↗
• MalfunctionJun 28, 2022Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, ON A LAPAROSCOPIC KIDNEY TRANSPLANT, DURING THE ANASTOMOSIS OF KIDNEY, WHILE IN THE RENAL VEIN, THE JAWS WERE UNABLE TO OPEN. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14844380 ↗
• MalfunctionMay 12, 2022Component Missing; Component Missing

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC NEPHRECTOMY, AT TRANSECTION OF RENAL ARTERY, THE DEVICE HAD NO STAPLES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14379724 ↗
• MalfunctionDec 21, 2021Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, WHEN STAPLING ARTERY DURING LAPAROSCOPIC LIVE DONOR NEPHRECTOMY, 2 STAPLERS WERE UNABLE TO FIRE WHEN HANDLE WAS SQUEEZED. A THIRD STAPLER WAS OPENED TO CONTINUE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13057140 ↗
• MalfunctionDec 21, 2021Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, WHEN STAPLING ARTERY DURING LAPAROSCOPIC LIVE DONOR NEPHRECTOMY, 2 STAPLERS WERE UNABLE TO FIRE WHEN HANDLE WAS SQUEEZED. A THIRD STAPLER WAS OPENED TO CONTINUE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13056996 ↗
• MalfunctionDec 1, 2021Component or Accessory Incompatibility; Difficult to Open or Close; Component or Accessory Incompatibility; Difficult to Open or Close

  ACCORDING TO THE REPORTER, BEFORE A BLOOD VESSEL TREATMENT FOR KIDNEY TRANSPLANTATION, AFTER OPENING, THE JAWS OF THE RELOAD COULD NOT BE OPENED AND COULD NOT BE USED. THERE WAS ALSO PROBLEM LOADING THE DEVICE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12909431 ↗
• MalfunctionSep 15, 2021Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING NEPHRECTOMY PROCEDURE, THE DEVICE DID NOT FIRE. A NEW RELOAD WAS USED TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: Insufficient Information

  MAUDE report 12475595 ↗
• MalfunctionMay 7, 2021Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, WHEN THE RIGHT KIDNEY ARTERY WAS CLOSED DURING A LAPAROSCOPIC KIDNEY TRANSPLANTATION, THE DEVICE WAS UNABLE 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 11793881 ↗
• MalfunctionApr 9, 2021Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, THE JAWS OF THE STAPLER WOULD NOT OPEN WHEN LOADING THE STAPLER.

  Patient problems: Insufficient Information

  MAUDE report 11645360 ↗
• MalfunctionDec 3, 2020Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, WHEN FIRING THE RENAL ARTERY ON A LAPAROSCOPIC KIDNEY TRANSPLANT, THE DEVICE WAS NOT ABLE 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 10942932 ↗
• MalfunctionNov 13, 2020Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING RENAL VEIN TREATMENT IN A LAPAROSCOPIC NEPHRECTOMY, THE TIP OF THE DEVICE WAS DIFFICULT TO OPEN. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 10835791 ↗
• MalfunctionNov 3, 2020Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, WHEN ATTEMPTING TO TRANSECT THE HILUM DURING A LAPAROSCOPIC DONOR NEPHRECTOMY, THE JAWS OF THE TWO DEVICES WOULD NOT OPEN. ANOTHER PRODUCT WAS USED. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 10777544 ↗
• MalfunctionNov 3, 2020Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, WHEN ATTEMPTING TO TRANSECT THE HILUM DURING A LAPAROSCOPIC DONOR NEPHRECTOMY, THE JAWS OF THE TWO DEVICES WOULD NOT OPEN. ANOTHER PRODUCT WAS USED. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 10777534 ↗
• MalfunctionOct 29, 2020Break; Break

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, AREA DURING THE CHECKING PHASE PRIOR TO INSERTION TO THE PATIENT, CRACK AND BREAKAGE WERE FOUND IN THE RELOAD. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 10758330 ↗
• MalfunctionOct 21, 2020Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING DONOR LIVER RESECTION, BEFORE HANDING THE DEVICE TO THE SURGEON, THE JAW WAS CLOSED, AND COULD NOT BE OPENED. ANOTHER HANDLE WAS USED 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 10713266 ↗
• MalfunctionOct 20, 2020Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY, THE SURGEON TRIED TO OPEN AND CLOSE JAWS BEFORE PUTTING IN THE PORT BUT IT WAS LOCKED. THE JAWS WOULD NOT OPEN OR CLOSE.

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

  MAUDE report 10703808 ↗
• InjuryOct 5, 2020Entrapment of Device; Failure to Form Staple; Adverse Event Without Identified Device or Use Problem; Entrapment of Device; Failure to Form Staple; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC LIVE DONOR NEPHRECTOMY, ON STAPLING OF THE RENAL ARTERY, WHEN THE SURGEON OPENED THE JAWS OF THE DEVICE THE ARTERY WAS STUCK TO THE WHITE PART OF THE CARTRIDGE AND SOME OF THE STAPLES HAD NOT FORMED. THERE WAS BLEEDING FROM THE ARTERY SO THE SURGEON PINCHED IT TO STOP IT AND THEN PLACED A CLIP. AFTER LEAVING IT FOR A WHILE WITH A SWAB ON IT, THE USER CAME BACK AND OOZING HAD SLOWED. THERE WAS NOT MORE THAN 500CC BLOOD LOSS BUT THE PROCEDURE WAS EXTENDED BY MORE THAN 30 MINUTES BECAUSE OF THE ISSUE. THERE WAS TISSUE DAMAGE. THE DEVICE WAS ABLE TO FIRE AND THE STAPLE LINE WAS INCOMPLETE. THE JAWS COULD NOT INITIALLY BE OPENED FULLY ON THE ARTERY. ONCE THE ARTERY WAS REMOVED FROM THE STAPLER AND IT WAS REMOVED FROM PATIENT CAVITY, IT WAS ABLE TO BE OPENED. THE SURGEON HAD TO MANUALLY FORCE OPEN WITH A GRASPER AND OVERSEW THE ARTERY TO RESOLVE THE ISSUE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Code Available; Tissue Damage; Unspecified Tissue Injury

  MAUDE report 10625638 ↗
• InjurySep 14, 2020Break; Entrapment of Device; Failure to Form Staple; Break; Entrapment of Device; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC DONOR NEPHRECTOMY, WHEN THE DEVICE WAS FIRED ON THE RENAL ARTERY FOR THE FIRST FIRING, WHEN THE SURGEON OPENED THE JAWS OF THE DEVICE, THE JAWS OPENED NORMALLY, BUT IT WAS NOTICED THAT THE RENAL ARTERY GOT STUCK ON THE CARTRIDGE SITE OF THE STAPLER AND COULD NOT BE RELEASED. THE SURGEON THEN CLOSED THE STAPLER AGAIN AS THE RENAL ARTERY WAS STUCK AND COULD NOT BE RELEASED. IT WAS ALSO NOTED THAT THE STAPLE LINE WAS INCOMPLETE; SOME STAPLES WERE PRESENT ON THE SIDE THAT TORE OF THE STAPLER AS BLOOD WAS NOT SQUIRTING FROM ONE AREAS, BUT SEVERAL SPOTS, SO STAPLES DID DEPLOY. THE SURGEON USED A CLIP APPLIER TO FIRE ON ONE SIDE OF THE STAPLER TO REMOVE THE KIDNEY, AND WAS GOING TO FIRE ON THE OTHER SIDE BUT THE RENAL ARTERY TORE OFF FROM THE CLOSED STAPLER JAWS, LEAVING MAJORITY OF THE STAPLED PORTION OF THE RENAL ARTERY INSIDE THE JAWS. ENOUGH PEDICLE WAS REMAINING TO COMPLETE THE CASE. IT WAS ALSO NOTED THAT THERE WAS AN UNANTICIPATED TISSUE LOSS. THE WHITE TIP OF THE STAPLER HAD BROKEN OFF AND WAS IN THE PACKAGE WITH THE STAPLER WHEN THE DEVICE WAS INSPECTED BY THE SALES REP.

  Patient problems: Tissue Damage; Unspecified Tissue Injury

  MAUDE report 10527890 ↗
• MalfunctionSep 11, 2020Break; Break

  ACCORDING TO THE REPORTER, PRIOR TO LAPAROSCOPIC DONOR NEPHRECTOMY, WHEN TRYING TO UNDO THE SAFETY MECHANISM, IT BROKE OFF. 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 10524738 ↗