GIA GIA80XTSRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10884521723566), received between Aug 23, 2022 and Aug 18, 2026 — classified as 2 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 18, 2026Retraction Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50306792 ↗
• InjuryFeb 18, 2026Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, SEVEN DAYS FOLLOWING A SURGERY, THERE WAS AN ANASTOMOTIC LEAK ON THE ANTERIOR ASPECT OF THE STAPLED COLO-COLONIC SIDE-TO-SIDE ANASTOMOSIS WITH A DEFECT OF 1.5 CM. ADDITIONAL SURGERY WAS PERFORMED.

  Patient problems: Failure to Anastomose; Tissue Breakdown; Unintended Radiation Exposure

  MAUDE report 24376588 ↗
• MalfunctionDec 19, 2025Misfire; Misfire

  IT WAS REPORTED THAT DURING A PROCEDURE, THE DEVICE DID NOT FIRE COMPLETELY TO THE DISTAL END. THE DEVICE WAS REPLACED WITH ANOTHER STAPLER FROM A DIFFERENT MANUFACTURER.

  Patient problems: Insufficient Information

  MAUDE report 23849724 ↗
• MalfunctionNov 7, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING COLON RESECTION BUT BEFORE USING IT ON THE PATIENT, WHEN THE PRODUCT WAS OPENED, THE BLACK FIRING KNOB WAS DETACHED AT THE TIME OF THE INITIALLY ASSEMBLED CARTRIDGE SIDE AND ANVIL SIDE. THE SAME NEW PRODUCT WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23498170 ↗
• MalfunctionAug 15, 2025Adverse Event Without Identified Device or Use Problem; Firing Problem; Adverse Event Without Identified Device or Use Problem; Firing Problem

  IT WAS REPORTED THAT DURING A RIGHT HEMICOLECTOMY FOR A PERFORATED APPENDIX; THE OPEN STAPLER WAS USED ON AN ILEOCOLIC ANASTOMOSIS. THE SURGEON EXPERIENCED A NEED FOR SIGNIFICANT FORCE TO FIRE THE STAPLER. UPON OPENING THE STAPLER, BLEEDING WAS OBSERVED AT THE ANASTOMOSIS STAPLE LINE. OVERSEWING OF THE STAPLE LINE INSIDE THE LUMEN WAS REQUIRED.

  Patient problems: Failure to Anastomose; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22821906 ↗
• MalfunctionJul 28, 2025Misfire; Misfire

  ACCORDING TO THE REPORTER, DURING AN ESOPHAGECTOMY WITH ROBOT SUPPORT, WHEN USED IN THE FOURTH FIRING IN NASOGASTRIC TUBE CREATION, IT FIRED UP TO ABOUT 1/3 AND BECAME IMPOSSIBLE, AND IT WAS RELEASED. TO RESOLVE THE ISSUE, THE CARTRIDGE WAS REPLACED, AND IT WAS FIRED NORMALLY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22638069 ↗
• InjuryApr 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A DAY AFTER THE ILEOCOLOSTOMY, AN ANASTOMOSIS LEAKAGE OCCURRED. THE PATIENT UNDERWENT REVISION SURGERY AND RECEIVED A TEMPORARY ANUS PRAETER. THE PATIENT EXPERIENCED EXTENDED HOSPITALIZATION AS A RESULT OF THESE EVENTS.

  Patient problems: Failure to Anastomose; Tissue Breakdown

  MAUDE report 21770215 ↗
• MalfunctionOct 12, 2023Failure to Fire; Detachment of Device or Device Component; Failure to Fire; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A SMALL BOWEL RESECTION FOR ISCHEMIA WHEN THE SURGEON WAS STAPLING THE DEVICE DID NOT FIRE, THE SURGEON WAS ABLE TO CLOSE THE STAPLER BUT IT WAS NOT ABLE TO FIRE. THE SURGEON THEN TRIED USING THREE MORE DIFFERENT KINDS OF RELOAD ALL OF WHICH WAS NOT ABLE TO FIRE. THE SURGEON THEN REPORTED THAT THE STAPLES WERE FALLING. THE SURGEON THEN TOOK ANOTHER TYPE OF STAPLER AND WAS ABLE TO STAPLE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17926344 ↗
• MalfunctionDec 5, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN PROCEDURE, WHILE TRYING TO COMPLETE THE STAPLE, THE DEVICE AS A WHOLE WAS BROKEN. THE DEVICE WAS REPLACED TO COMPLETE THE CASE AND RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15921078 ↗
• MalfunctionAug 23, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRIOR TO A COLORECTAL PROCEDURE, THE BLACK ADVANCING FIRING KNOB ON THE DEVICE FELL OFF WHILE IT WAS BEING PREPARED FOR USE IN SURGERY. THE DEVICE WAS NOT USED TO PATIENT. A NEW DEVICE WAS OPENED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15279079 ↗
• MalfunctionAug 23, 2022Misfire; Misfire

  ACCORDING TO THE REPORTER, DURING THE OPEN MINI- OR LESS-OPEN SUBLAY (MILOS) HERNIA REPAIR, ON RESECTION OF THE RECTAL BED, AFTER 50% OF FIRING, THE STAPLER WAS NOT ABLE TO FIRE. THE STAPLER WAS FIXED IN ITS POSITION AND THE FIRING KNOB CANNOT BE PUSHED LONGER. A NEW STAPLER WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15276165 ↗