GIA GIA80XTCRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10884521723535), received between Dec 1, 2022 and Mar 23, 2026 — classified as 2 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Misfire” (4 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 23, 2026Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING A COLON RESECTION, THE STAPLE LINE FROM THE TWO ADDITIONAL RELOADS WAS INCOMPLETE. TO RESOLVE THE ISSUE, A PURPLE RELOAD, WHICH WAS NOT INDICATED FOR USE IN THE COLON, WAS UTILIZED TO COMPLETE THE COLON RESECTION.

  Patient problems: Tissue Breakdown

  MAUDE report 24664974 ↗
• 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 24376611 ↗
• 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 22820477 ↗
• MalfunctionJul 31, 2025Break; Break

  IT WAS REPORTED THAT THE CARTRIDGE/RELOAD BROKE. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22674676 ↗
• 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 22630519 ↗
• MalfunctionMay 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT INTRAOPERATIVELY, THERE WAS A FIRING ISSUE AND DEFECT IN TISSUE BINDING. A NEW CARTRIDGE WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 22040919 ↗
• MalfunctionSep 11, 2024Misfire; Misfire

  ACCORDING TO THE REPORTER, DURING THE ESOPHAGECTOMY WITH GASTRECTOMY, THE FIRST FIRING COULD BE DONE WITHOUT ANY PROBLEMS, BUT THE SECOND FIRING AFTER REPLACING THE CARTRIDGE COULD BE FIRED ONLY HALFWAY. FROM THE PART WHERE THE FIRING COULD NOT BE DONE WAS REPLACED WITH A NEW CARTRIDGE AND THE FIRING WAS COMPLETED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20190321 ↗
• MalfunctionAug 28, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE STAPLER RELOAD DID NOT FIRE, COULD NOT MOVE THE BLACK KNOB FORWARD 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 20091706 ↗
• MalfunctionAug 27, 2024Misfire; Misfire

  ACCORDING TO THE REPORTER, DURING A GASTRECTOMY PROCEDURE, ON THE STOMACH RESECTION, THERE WAS NO PROBLEM WITH THE FIRST AND SECOND SHOTS IN THE SAME MAIN UNIT. HOWEVER, ON THE THIRD SHOT, THE KNIFE DID NOT ADVANCE HALFWAY. HENCE, THE DEVICE PARTIALLY FIRED. TO RESOLVE THE ISSUE, ADDITIONAL RESECTION WAS PERFORMED, AND ADDITIONAL STAPLING WAS ALSO PERFORMED WITH A NEW RELOAD AND THE SAME HANDLE.

  Patient problems: Tissue Breakdown

  MAUDE report 20076132 ↗
• MalfunctionDec 7, 2023Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHEN THE NURSES TRIED THE DEVICE MULTIPLE TIMES, THE DEVICE WAS NOT WORKING. THE DEVICE DID NOT FIRE. THE DEVICE WAS REPLACED TO RESOLVE THE ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 18287067 ↗
• 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 17925905 ↗
• InjuryDec 1, 2022Misfire; Misfire

  ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC SMALL BOWEL RESECTION, WHEN DOING SIDE TO SIDE ANASTOMOSIS, THE STAPLER PARTIALLY FIRED. THE STAPLER WORKED PROPERLY WHEN FIRE ON THE CARTRIDGE THAT CAME PACKAGED WITH THE STAPLER. OVERSEWING WAS PERFORMED TO COMPLETE THE ANASTOMOSIS.

  Patient problems: Failure to Anastomose; Unspecified Tissue Injury

  MAUDE report 15896413 ↗