Multifire Endo GIA 030805LRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10884523003765), received between Aug 4, 2017 and Feb 4, 2022 — classified as 5 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Failure to Form Staple” (3 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 4, 2022Failure to Cut; Adverse Event Without Identified Device or Use Problem; Failure to Cut; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING AN OPEN ZENKERS DIVERTICULECTOMY, ON TRANSECTION OF THE POUCH, THE RELOAD THAT CAME WITH THE STAPLE HANDLE FIRED SUCCESSFULLY. THE SECOND RELOAD THAT WAS LOADED ON TO THE STAPLE HANDLE FIRED STAPLES, BUT DID NOT CUT. THE SURGEON MANUALLY CUT BETWEEN THE STAPLE LINES TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 13458004 ↗
• InjuryFeb 14, 2019Mechanics Altered; Mechanics Altered

  ACCORDING TO THE REPORTER, DURING AN EXTENDED RIGHT HEPATIC LOBECTOMY PROCEDURE, WHILE THE DEVICE WAS BEING APPLIED TO THE RIGHT HEPATIC VEIN AT THE JUNCTION WITH THE SUPRAHEPATIC VENA CAVA, THE SURGEON WAS ABLE TO SQUEEZE THE HANDLE AND THE STAPLER CUT BUT DID NOT FIRE. IT WAS NOTED THAT THERE WERE NO STAPLES VISIBLE ON THE HEPATIC VEIN, BUT SOME STAPLES WERE LEFT IN THE CARTRIDGE. SUTURING WAS DONE AND THE PATIENT WAS TRANSFUSED WITH 8 UNITS OF BLOOD AND 2500CC OF CELL-SAVER, WHICH RESULTED IN AN EXTENDED HOSPITAL STAY OF 10 DAYS. THERE WAS MORE THAN 500CC OF BLOOD LOSS AND THE SURGICAL TIME WAS EXTENDED FOR MORE THAN 30 MINUTES.

  Patient problems: Blood Loss; No Code Available

  MAUDE report 8341780 ↗
• InjurySep 4, 2018Entrapment of Device; Misfire; Failure to Form Staple; Component or Accessory Incompatibility; Entrapment of Device; Misfire; Failure to Form Staple; Component or Accessory Incompatibility

  ACCORDING TO THE REPORTER: DURING AN OPEN PELVIC EXENTERATION, WHEN THE STAPLER WAS BEING APPLIED TO THE INTERNAL ILIAC VESSEL, THE SCRUB NURSE STRUGGLED TO RELOAD THE STAPLER INITIALLY. THE SUPPORTING SURGEON HELPED IN LOADING THE RELOAD ONTO THE HANDLE. WHEN THE SURGEON TRIED TO FIRE THE STAPLER THE DEVICE MADE A LARGE CRACKING NOISE AND GOT STUCK TO THE VESSEL. THERE WERE POOR STAPLE FORMATION AND THE DISTAL STAPLE LINE WAS INCOMPLETE. THE SURGEON STRUGGLED TO REMOVE THE DEVICE AND DECIDED TO CLAMP THE VESSEL AND TIE IT OFF. ONCE THE STAPLER WAS REMOVED THE STAPLES WERE PARTIALLY FIRED. THE HANDLE AND FIRST RELOAD HAD BEEN FIRED SUCCESSFULLY, HOWEVER THIS WAS THE SECOND RELOAD ON THE DEVICE. THE SURGEON HAD TO CLAMP THE INTERNAL ILIAC VEIN AND THEN SEW THE VESSEL BEFORE REMOVING THE STAPLER IN ORDER TO ENSURE HAEMOSTASIS WAS ACHIEVED AND THE VESSEL DID NOT RUPTURE. THE SURGICAL TIME WAS EXTENDED BY MORE T HAN 30 MINUTES.

  Patient problems: No Code Available

  MAUDE report 7842489 ↗
• MalfunctionAug 1, 2018Misfire; Failure to Fire; Misfire

  ACCORDING TO THE REPORTER, THE STAPLING DEVICE DID NOT FIRE WHEN TRYING TO PUT INTO PATIENT. THE DEVICE MISFIRED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7738588 ↗
• InjuryMay 8, 2018Failure to Form Staple; Adverse Event Without Identified Device or Use Problem; Failure to Form Staple; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC DONOR NEPHRECTOMY, THE STAPLER WAS FIRED ON THE URETER WITHOUT INCIDENT THEN THE STAPLER WAS RELOADED AND FIRED ON THE RENAL ARTERY. WHEN THE STAPLER WAS OPENED, SEVERE BLEEDING OF MORE THAN 500CC WAS OBSERVED AND THERE WAS INTERRUPTION OF THE STAPLE LINE. THE LAPAROSCOPIC PROCEDURE WAS CONVERTED TO OPEN; THE KIDNEY WAS REMOVED FOR TRANSPLANTATION AND THE RENAL ARTERY TISSUE WAS HAND SEWN AND TRIMMED TO STOP THE BLEEDING. BLOOD TRANSFUSION WAS REQUIRED, SURGICAL TIME AND INCISION WAS EXTENDED AND AN X-RAY WAS ALSO DONE TO DETERMINE IF ANY COMPONENTS WERE LEFT BEHIND.

  Patient problems: Blood Loss; No Code Available; Radiation Exposure, Unintended

  MAUDE report 7495791 ↗
• MalfunctionNov 16, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER: OCCURRED DURING A LAPAROSCOPIC APPENDECTOMY. AFTER THE DEVICE HAD FIRED THERE WAS BLEEDING FROM THE STAPLE LINE. THE CASE WAS COMPLETED USING CLIPS. NO PATIENT INJURY.

  Patient problems: No Code Available; No Known Impact Or Consequence To Patient

  MAUDE report 7037513 ↗
• MalfunctionOct 23, 2017Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING AN APPENDECTOMY PROCEDURE, THE TIP/ JAWS DID NOT OPEN. ANOTHER DEVICE WAS USED IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6968549 ↗
• InjuryOct 13, 2017Entrapment of Device; Entrapment of Device

  ACCORDING TO THE REPORTER: OCCURRED DURING A LAPAROSCOPIC APPENDECTOMY. WHILE TRANSECTING THE APPENDIX THE JAWS OF THE DEVICE GOT LOCKED ON THE TISSUE. IN ORDER TO REMOVE THE INSTRUMENT, THEY HAD TO STAPLE AROUND THE DEVICE TO REMOVE IT. PATIENT STATUS IS ALIVE WITH NO INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6947721 ↗
• MalfunctionOct 6, 2017Failure to Fire; Human-Device Interface Problem; Failure to Fire; Human-Device Interface Problem

  ACCORDING TO THE REPORTER: DURING A LAPAROSCOPIC APPENDECTOMY, THE SCRUB TECH COULD NOT REMOVE THE DEVICE LOADING UNIT FROM THE INSTRUMENT. THE SURGEON WAS NOT ABLE TO SQUEEZE THE HANDLE OR FIRE THE DEVICE. ANOTHER MULTIFIRE ENDO GIA 30 2.5 WAS USED TO COMPLETE THE SURGERY. THERE WAS NO INJURY TO THE PATIENT OR ADDITIONAL MEDICAL OR SURGICAL INTERVENTION REQUIRED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6922035 ↗
• MalfunctionAug 4, 2017Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC APPENDECTOMY PROCEDURE, THERE WAS POOR STAPLE FORMATION ON THE DISTAL END OF THE STAPLE LINE. MALFORMED STAPLES WERE REMOVED FROM THE PATIENT. ANOTHER STAPLER WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6769642 ↗