GIA GIA60MTSRecalls & reported problems

Summary

The FDA's MAUDE database contains 45 adverse event reports that list this exact device (DI 10884521723436), received between Nov 7, 2021 and Sep 23, 2026 — classified as 1 death, 3 injuries, 41 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (12 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 45 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2026Failure to Fire

  It was reported that during a procedure, the stapler got stuck. The device was replaced with a new stapler. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50864979 ↗
• MalfunctionJun 25, 2026Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY, AFTER FIRING, THE SURGEON DREW THE BLACK FIRING PLATE BACK AND THE BLACK PLATE BROKE OFF THE STAPLER AND FELL TO THE FLOOR. THE SURGEON NEEDED ANOTHER RELOAD SO HE HAD TO TAKE A NEW STAPLER ; HOWEVER, THE SAME ISSUE OCCURRED. THE DEVICE WAS REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25630409 ↗
• MalfunctionJun 25, 2026Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY, AFTER FIRING, THE SURGEON DREW THE BLACK FIRING PLATE BACK AND THE BLACK PLATE BROKE OFF THE STAPLER AND FELL TO THE FLOOR. THE SURGEON NEEDED ANOTHER RELOAD SO HE HAD TO TAKE A NEW STAPLER; HOWEVER, THE SAME ISSUE OCCURRED. THE DEVICE WAS REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25630405 ↗
• MalfunctionApr 14, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A WHIPPLE PROCEDURE, AFTER USING THE OPEN STAPLER, TOWARDS THE END OF THE PROCEDURE, STAPLES OPENED ON THE GASTROJEJUNOSTOMY OR DUODENOJEJUNOSTOMY ANASTOMOSIS. TO RESOLVE THE ISSUE, RESTAPLING WAS DONE.

  Patient problems: Tissue Breakdown

  MAUDE report 24880014 ↗
• MalfunctionFeb 25, 2026Failure to Fire

  IT WAS REPORTED THAT DURING A PROCEDURE, THE INSTRUMENT DID NOT FIRE AFTER THE SECOND LOADING UNIT WAS PUT INTO THE DEVICE, AND THE BLACK PUSHER THUMB PIECE WAS NOT MOVING, AND THE SAME CYCLE HAPPENED TWICE. THE DEVICE WAS REPLACED TO RESOLVE THE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24446402 ↗
• MalfunctionFeb 25, 2026Failure to Fire

  IT WAS REPORTED THAT DURING A PROCEDURE, THE INSTRUMENT DID NOT FIRE AFTER THE SECOND LOADING UNIT WAS PUT INTO THE DEVICE, AND THE BLACK PUSHER THUMB PIECE WAS NOT MOVING, AND THE SAME CYCLE HAPPENED TWICE. THE DEVICE WAS REPLACED TO RESOLVE THE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24446377 ↗
• MalfunctionNov 11, 2025Misfire; Misfire

  ACCORDING TO THE REPORTER, DURING A TOTAL COLECTOMY, WHILE ON J POUCH CREATION IN THE SMALL INTESTINE, THE FIRING COULD NOT BE COMPLETED TO THE DISTAL END. THE CARTRIDGE WAS REPLACED, AND IT WAS RESOLVED WITHOUT INCIDENT. REGARDING THE STAPLER, THE SAME STAPLER WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23521979 ↗
• MalfunctionOct 21, 2025Misfire; Misfire

  ACCORDING TO THE REPORTER, DURING A THORACIC, AT THE TIME OF FIRING, THE WHITE FLAG ENGAGED, AND THEN THE DEVICE PARTIALLY FIRED. SUTURING WAS DONE AS A STAPLE LINE REPLACEMENT.

  Patient problems: Tissue Breakdown

  MAUDE report 23346969 ↗
• MalfunctionAug 1, 2025Misfire; Misfire

  ACCORDING TO THE REPORTER DURING A PROCEDURE, THE DEVICE PARTIALLY FIRED.

  Patient problems: Insufficient Information

  MAUDE report 22690016 ↗
• MalfunctionJul 28, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT PRE-OPERATIVELY, THE DEVICE DID NOT FIRE. THE DEVICE WAS REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22638911 ↗
• MalfunctionJul 24, 2025Mechanics Altered; Mechanics Altered

  IT WAS REPORTED THAT DURING AN OPEN COLECTOMY, THE STAPLER EXPERIENCED FIRING ISSUES DURING USE, INCLUDING STAPLES NOT DEPLOYING AND THE DEVICE CUTTING WITHOUT DEPLOYING STAPLES. THE DEVICE WAS REPLACED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Tissue Breakdown

  MAUDE report 22594580 ↗
• MalfunctionJun 23, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE CUTTER KNOB BROKE OFF AS SCRUB PERSON WAS GETTING READY TO USE THE DEVICE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22305952 ↗
• MalfunctionJun 19, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN OPEN ILECTOMY, WHEN THE LINEAR STAPLER WAS PLACED ON THE SURGICAL TABLE, THE BLACK INSERT FELL OFF, CAUSING THE BLADE TO SHIFT. ANOTHER STAPLER WAS PLACED ON THE TABLE, AND THE SAME ISSUE OCCURRED. A PURPLE 60-GAUGE REFILL WASALSO USED, AND THERE WAS INCOMPLETE STAPLE LINE; ONE END OF THE HANDLE REMAINED OPEN. A MANUAL SUTURE WAS USED TO RESOLVE THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22293228 ↗
• MalfunctionJun 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN ILEUS SITUATION INVOLVING A HARTMANN PROCEDURE, AN ILEOSTOMY WAS CREATED. THE DEVICE WAS INITIALLY USED FOR THE TRANSECTION OF THE TRANSVERSE COLON. A NEW RELOAD WAS UTILIZED WITH THE INSTRUMENT FOR THE TRANSECTION OF THE ILEUM. THE SURGEON OBSERVED A 0.5CM LEAK IN THE MIDDLE OF THE STAPLE LINE OF THE TRANSVERSE COLON. THE STAPLE LINE LEAKED THE CONTENTS CONTAINED WITHIN THE TISSUE. TO ADDRESS THE ISSUE, THE AFFECTED AREA WAS RESECTED AND RE-STAPLED.

  Patient problems: Tissue Breakdown

  MAUDE report 22176388 ↗
• MalfunctionJan 3, 2025Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING A COLON TRANSVERSUM RESECTION PROCEDURE INVOLVING THE STAPLER, THERE WAS AN INCOMPLETE STAPLE LINE AT THE DISTAL END. THE DEVICE WAS REPLACED TO RESOLVE THE ISSUE.

  Patient problems: Tissue Breakdown

  MAUDE report 21071875 ↗
• MalfunctionOct 3, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE STAPLER DID NOT FIRE. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20361027 ↗
• MalfunctionJun 25, 2024Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING A PARTIAL COLORECTAL RESECTION, THE STAPLES WERE DIFFICULT TO FIRE AND A CRACK EXISTED THAT HAD TO BE SUTURED TO COMPLETE AND REINFORCE THE PROCEDURE AND STAPLE LINE. THE SURGICAL TIME WAS EXTENDED DUE TO THE ISSUE.

  Patient problems: Failure to Anastomose; Tissue Breakdown

  MAUDE report 19608473 ↗
• MalfunctionJun 8, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING AN OPEN RIGHT HEMICOLECTOMY, THE SURGEON WAS UNABLE TO PUSH THE TRIGGER, PREVENTING THE STAPLES TO FIRE. THE ISSUE OCCURRED ON TWO STAPLERS. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19494616 ↗
• MalfunctionJun 7, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING AN OPEN RIGHT HEMICOLECTOMY, THE SURGEON WAS UNABLE TO PUSH THE TRIGGER, PREVENTING THE STAPLES TO FIRE. THE ISSUE OCCURRED ON TWO STAPLERS. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19490008 ↗
• MalfunctionApr 16, 2024Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING AN OPEN GASTRECTOMY PROCEDURE, WHEN FIRING THE LAST THREE STAPLES, THERE WAS POOR STAPLE FORMATION. IT CANNOT FORCE B-SHAPED. THE SURGEON RESECTED AND RE-STAPLED TO FIX THE STAPLE LINE. A NEW CARTRIDGE STAPLE WAS USED WITH THE SAME STAPLER TO RESOLVE THE ISSUE.

  Patient problems: Tissue Breakdown

  MAUDE report 19117519 ↗
• MalfunctionJan 11, 2024Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING AN OPEN SEGMENTAL RESECTION OF THE SMALL INTESTINE, WHEN CUTTING THE SMALL INTESTINE WITH THE STAPLER, AFTER THE STAPLER WAS FIRED, ONLY ONE SIDE WAS CLOSED WITH THE STAPLES. THE DEVICE WAS FIRED DOWN COMPLETELY, BUT SOME STAPLES WERE MISSING FROM THE STAPLE LINE. IT WAS NOTED THAT IT ALSO HAPPENED ON THE RELOAD UNITS, AND THERE WAS NO CORRECT CLOSURE OF BOTH SIDES WITH STAPLES OR DID NOT FORM PROPER SHAPE. TO RESOLVE THE ISSUE, THE SMALL INTESTINE WAS CLOSED WITH A CLAMP, AND THE DESIRED MANUAL ANASTOMOSIS WAS PERFORMED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18499879 ↗
• DeathNov 29, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A REVERSAL OF THE ILEOSTOMY OPEN PROCEDURE, WHEN THE PRODUCT WAS OPENED TO BEGIN THE RESECTION, THE BOTTOM GRAY PLASTIC PIECE FLEW OFF AND FELL ONTO THE FLOOR. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. IT WAS NOTED THAT THE PATIENT HAS PASSED AWAY AND THERE WAS A LEAK.

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

  MAUDE report 18231160 ↗
• MalfunctionNov 20, 2023Failure to Align; Failure to Align

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SURGERY, THE CANNULA BROKE, AND THE TWO HALVES OF THE OPEN STAPLER DID NOT JOIN AND LOCK INTO PLACE AS USUAL AT THE HINGE PIN. A NEW TROCAR AND OPEN STAPLER WERE USED IN ORDER TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18170490 ↗
• MalfunctionAug 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING OPEN BOWEL RESECTION, THE STAPLE LINE LOOKED GOOD AFTER FIRING. HOWEVER, THE STAPLE LINE COMPLETELY SPLIT OPEN. THIS HAPPENED ON THREE STAPLERS CONSECUTIVELY. THE EVENT LED TO TISSUE LOSS.

  Patient problems: Tissue Breakdown

  MAUDE report 17452018 ↗
• MalfunctionAug 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING OPEN BOWEL RESECTION, THE STAPLE LINE LOOKED GOOD AFTER FIRING. HOWEVER, THE STAPLE LINE COMPLETELY SPLIT OPEN. THIS HAPPENED ON THREE STAPLERS CONSECUTIVELY. THE EVENT LED TO TISSUE LOSS.

  Patient problems: Tissue Breakdown

  MAUDE report 17451753 ↗