Multifire Endo TA 010911LRecalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10884521047761), received between Feb 21, 2017 and Jul 10, 2024 — classified as 7 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Failure to Form Staple” (6 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 10, 2024Failure to Fire; Insufficient Device Problem Information; Failure to Fire; Insufficient Device Problem Information

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19711992 ↗
• MalfunctionOct 16, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRIOR TO USE OF THE DEVICE, THE STAPLE WAS UNLOADED. ANOTHER RELOAD WAS USED WITH THE SAME HANDLE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17943395 ↗
• 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 15512325 ↗
• InjuryOct 14, 2019Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, AT THE RENAL ARTERY DURING A LAPAROSCOPIC LIVE DONOR NEPHRECTOMY, THERE WAS A POOR STAPLE FORMATION AT THE ROW OF STAPLES ACROSS THE ARTERY. THE PATIENT REQUIRED A LAPAROTOMY AS A SURGICAL INTERVENTION WHICH EXTENDED THE INCISION. THE STAPLE LINE WAS FIXED WITH A SUTURE. THE SURGICAL TIME EXTENDED MORE THAN 30 MINUTES. THE PATIENT LOST THREE LITERS OF BLOOD, SO 2 UNITS OF BLOOD TRANSFUSION WERE ALSO REQUIRED. THE PATIENT HOSPITALIZATION WAS EXTENDED.

  Patient problems: Blood Loss; Exsanguination; No Code Available

  MAUDE report 9189194 ↗
• MalfunctionFeb 27, 2019Failure to Form Staple; Component or Accessory Incompatibility; Human-Device Interface Problem; Failure to Form Staple; Component or Accessory Incompatibility; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, WHEN THEY FIRED THE DEVICE INTO THE VESSELS IN A LAPAROSCOPIC PROCEDURE, THERE WAS PROBLEM IN LOADING AND UNLOADING THE DEVICE BUT THE STAPLES SLID RIGHT OFF THE VESSELS. THEY USED CLIPS TO OCCLUDE THE VESSELS AND IT RESOLVED THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8374704 ↗
• MalfunctionDec 18, 2018Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A KIDNEY TRANSPLANT, THE RELOAD WAS STUCK AND CANNOT BE FIRED. THE DOCTOR PUT A SECOND SET OF RELOAD AND STILL CANNOT BE FIRED. THE PHYSICIAN OPENED ANOTHER SET OF STAPLER AND COMPLETED THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8175305 ↗
• MalfunctionDec 17, 2018Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, PRIOR A LAPAROSCOPIC LIVING DONOR NEPHRECTOMY, THEY TRIED TO SQUEEZE THE HANDLE TO FIRE BUT THE HANDLE COULD NOT BE SQUEEZED. THE CARTRIDGE WAS REPLACED AND TRIED TO BE USED AGAIN, BUT THE DEVICE STILL COULD NOT FIRE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THE PROCEDURE WAS EXTENDED BY LESS THAN 30 MINUTES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8171639 ↗
• InjuryDec 13, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A RENAL TRANSPLANTATION, WHILE CUTTING THE RENAL ARTERY, BLEEDING OCCURRED. WITH THIS, THE PROCEDURE WAS CONVERTED FROM LAPAROSCOPIC PROCEDURE TO OPEN DUE TO THE DEVICE PROBLEM. IT WAS ALSO REPORTED THAT KIDNEY WAS LOST, TISSUE WAS DAMAGED DUE TO PATIENT SHOCK SUPPLER CARDIOPULMONARY RESUSCITATION (CPR) AND INTENSIVE CARE UNIT (ICU). BLOOD LOSS OF 500CC OR MORE DUE TO PRODUCT PROBLEM. SURGICAL TIME EXCEEDED BY 30 MINUTES HOSPITAL STAY WAS EXTENDED AS WELL. SURGEON DID A RE-SUTURING AND RE-CUTTING.

  Patient problems: Blood Loss; No Code Available; Tissue Damage

  MAUDE report 8160217 ↗
• MalfunctionNov 7, 2018Failure to Form Staple; Human-Device Interface Problem; Failure to Form Staple; Human-Device Interface Problem

  ACCORDING TO THE REPORTER DURING A LAPAROSCOPIC LIVER TRANSPLANTATION, AFTER THE STAPLING, THE FIRST CARTRIDGE WAS NOT SEPARATED PROPERLY, AND THE THIRD CARTRIDGE WAS NOT REMOVED AT ALL AT THE SAME TIME THERE WAS POOR STAPLE FORMATION AS THE STAPLES DIDN'T LOOK LIKE A "GOOD B SHAPE". A NEW DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT HARM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8047024 ↗
• InjuryOct 22, 2018Entrapment of Device; Entrapment of Device

  ACCORDING TO THE REPORTER, DURING A ROBOTIC LAPAROSCOPIC KIDNEY DONOR NEPHRECTOMY, THE FIRST PRELOADED RELOAD WAS ABLE TO FIRE BUT THE SECOND RELOAD WAS LOADED AND GOT STUCK ON THE VESSELS AND WOULD NOT RELEASE. THEY USED ANOTHER STAPLER TO CUT AROUND THE STUCK STAPLER TO RESOLVE THE ISSUE AND COMPLETE THE CASE.

  Patient problems: No Code Available; Tissue Damage

  MAUDE report 7991122 ↗
• MalfunctionSep 19, 2018Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING THE RENAL ARTERY LIGATION ON A LAPAROSCOPIC KIDNEY TRANSPLANT PROCEDURE, THE STAPLE DID NOT FORM WELL. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7891477 ↗
• MalfunctionApr 26, 2018Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC DONOR NEPHRECTOMY (LEFT SIDE), THE DEVICE WAS ABLE TO FIRE, BUT THE STAPLES ON THE RELOAD AND TISSUE ARE MALFORMED. THE DOCTOR FIRED THE DEVICE ON THE RENAL VEIN (3RD FIRING). ON FIRST FIRING, URETER, SECOND, RENAL ARTERY, THIRD: RENTAL VEIN. UPON COMPLETION OF FIRING, THE DOCTOR ATTEMPTED TO OPEN THE STAPLER BUT THE TISSUE/STAPLES WERE STUCK TO THE RELOAD. THE DOCTOR WAS ABLE TO FIRE TWO CLIPS BELOW THE JAWS OF THE RELOAD AND HAD TO CUT THE TISSUE TO REMOVE THE TISSUE FROM THE STAPLER. THERE WAS UNANTICIPATED TISSUE LOSS AND TISSUE DAMAGE A RESULT OF THE ISSUE. A LOSS OF 1-2MM TISSUE WAS NOTED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient; Tissue Damage

  MAUDE report 7465169 ↗
• MalfunctionMar 30, 2018Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING OPEN NEPHRECTOMY PROCEDURE, WHILE THE DEVICE WAS BEING USED TO STAPLE THE VESSELS, THE DEVICE WAS UNABLE TO FIRE AND HAD POOR STAPLE FORMATION. THEY ALSO SAW FEW PUSHING BARS CAME UP. THEY TOOK A NEW LOADING TO RESOLVE THE ISSUE AND COMPLETE THE CASE. NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7385381 ↗
• InjuryJun 27, 2017Mechanics Altered; Mechanics Altered

  ACCORDING TO THE REPORTER DURING A RIGHT HAND-ASSISTED NEPHRECTOMY, NO STAPLES WERE ABLE TO BE DEPLOYED WHEN FIRED AND THE ARTERY LEAKED CONSIDERABLE BLOOD. MEDICAL OR SURGICAL INTERVENTION WAS NEEDED TO PREVENT PERMANENT IMPAIRMENT OF FUNCTION. THE SURGEON USED SUTURE TO CONTROL THE BLEEDING AND COMPLETE THE CASE. THERE WAS BLOOD LOSS OF 500CC OR MORE. HOWEVER, BLOOD TRANSFUSION WAS NOT REQUIRED. CURRENT PATIENT STATUS IS ALIVE WITH NO INJURY. NO REINFORCEMENT MATERIAL WAS USED. NO OTHER PATIENT ADVERSE EVENTS WERE REPORTED.

  Patient problems: Blood Loss

  MAUDE report 6670086 ↗
• InjuryJun 27, 2017Mechanics Altered; Mechanics Altered

  ACCORDING TO THE REPORTER DURING A RIGHT HAND-ASSISTED NEPHRECTOMY, NO STAPLES WERE ABLE TO BE DEPLOYED WHEN FIRED AND THE ARTERY LEAKED CONSIDERABLE BLOOD. MEDICAL OR SURGICAL INTERVENTION WAS NEEDED TO PREVENT PERMANENT IMPAIRMENT OF FUNCTION. THE SURGEON USED SUTURE TO CONTROL THE BLEEDING AND COMPLETE THE CASE. THERE WAS BLOOD LOSS OF 500 CC OR MORE. HOWEVER, BLOOD TRANSFUSION WAS NOT REQUIRED. CURRENT PATIENT STATUS IS ALIVE WITH NO INJURY. NO REINFORCEMENT MATERIAL WAS USED. NO OTHER PATIENT ADVERSE EVENTS WERE REPORTED.

  Patient problems: Blood Loss

  MAUDE report 6669220 ↗
• InjuryFeb 21, 2017Entrapment of Device; Entrapment of Device

  ACCORDING TO THE REPORTER, DURING A DONOR NEPHRECTOMY PROCEDURE, THE DEVICE WAS FIRED ON THE RENAL VEIN. ONLY PART OF THE STAPLES FIRED AND DID NOT RELEASE FROM THE STAPLER. THE STAPLER WAS STUCK TO THE VEIN AND THE TISSUE HAD TO BE RESECTED IN ORDER TO REMOVE THE DEVICE.

  Patient problems: Tissue Damage

  MAUDE report 6347377 ↗