GIA GIA80MTCRecalls & reported problems

Summary

The FDA's MAUDE database contains 164 adverse event reports that list this exact device (DI 10884521723528), received between Feb 23, 2021 and Sep 18, 2026 — classified as 27 injuries, 137 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (47 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 25 most recent of 164 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2026Failure to Form Staple

  According to the reporter, during the procedure, the stapler had firing issues, forming an incomplete staple line at the distal end. A new device was used to complete the procedure. There was no patient injury reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50819927 ↗
• MalfunctionSep 17, 2026Misfire

  According to the reporter, during a transverse colectomy, when performing functional end-to-end (FEEA) anastomosis, when it was used for closure of the insertion hole on the fourth firing, the firing knob became too hard midway and could no longer be advanced. Upon confirmation, forceps and the like were not caught inside. Hence, it could not be advanced; the firing knob was returned. To resolve the issue, a new stapler and cartridge were taken out and used, and resection was performed.

  Patient problems: Failure to Anastomose

  MAUDE report 50807323 ↗
• MalfunctionAug 14, 2026Protective Measures Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50260996 ↗
• MalfunctionAug 14, 2026Failure to Form Staple

  Patient problems: Tissue Breakdown

  MAUDE report 50253307 ↗
• MalfunctionAug 14, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Tissue Breakdown

  MAUDE report 50251308 ↗
• InjuryJul 29, 2026Break

  It was reported that during a surgical procedure, the interlock broke. The procedure initially began as a diagnostic surgery and was converted to an exploratory laparotomy with resection, omentectomy, left hemicolectomy, proximal and distal bowel closure, and loop ileostomy. It was noted that the procedure time was extended by approximately 20 minutes. The device issue was addressed by performing a power-on reset and using another reload from a different lot. The patient had an extended hospitalization and was admitted to the intensive care unit; however, the ICU admission was not related to the reported blade break. The ICU admission was due to the conversion of the procedure and the patient's underlying pathology, which resulted in a more complex surgical intervention. Based on the available information, the patient's clinical condition at the time of ICU admission was considered guarded; however, this was attributable to the complexity of the surgical procedure rather than the reported device event. The prolonged hospitalization was also not directly associated with the reported device event.

  Patient problems: Tissue Breakdown

  MAUDE report 50065722 ↗
• MalfunctionJun 30, 2026Failure to Fire

  ACCORDING TO THE REPORTER, DURING AN OPEN HEMICOLECTOMY, THE TWO RELOADS COULD NOT BE FIRED ON THE SAME HANDLE. A NEW HANDLE AND RELOAD WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25668251 ↗
• MalfunctionApr 20, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A GASTRIC RESECTION PROCEDURE, AN OPEN STAPLER WAS USED AND, AFTER FIRING, THE STAPLE LINE BURST OPEN AND A STAPLE LINE LEAK WAS OBSERVED WITH LEAKAGE OF THE CONTENTS BEING HELD BY THE TISSUE, WHICH WAS DISCOVERED DURING THE PROCEDURE. A LEAK TEST RESULT WAS RECORDED AS NOT AVAILABLE. THE REPORTED PATIENT IMPACT WAS UNKNOWN, AND NO PATIENT SYMPTOMS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 24923144 ↗
• MalfunctionMar 24, 2026Material Separation

  IT WAS REPORTED THAT PRE-OPERATIVELY, THE STAPLE COMPONENT BROKE. THE BROKEN PART DID NOT DISENGAGE. THE DEVICE WAS REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24673444 ↗
• MalfunctionMar 5, 2026Failure to Form Staple; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING HEMICOLECTOMY AND ILEOCOLIC ANASTOMOSIS, AN INCOMPLETE STAPLE LINE WAS NOTED. THERE WAS NO CONTINUITY OF STAPLES IN TWO SEGMENTS, RESULTING IN INTESTINAL CONTENT LEAKAGE. THE AFFECTED INTESTINAL SEGMENT REQUIRED MANUAL RESECTION AND ANASTOMOSIS.

  Patient problems: Failure to Anastomose

  MAUDE report 24515823 ↗
• MalfunctionMar 5, 2026Failure to Form Staple; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING HEMICOLECTOMY AND ILEOCOLIC ANASTOMOSIS, AN INCOMPLETE STAPLE LINE WAS NOTED. THERE WAS NO CONTINUITY OF STAPLES IN TWO SEGMENTS, RESULTING IN INTESTINAL CONTENT LEAKAGE. THE AFFECTED INTESTINAL SEGMENT REQUIRED MANUAL RESECTION AND ANASTOMOSIS.

  Patient problems: Failure to Anastomose

  MAUDE report 24515429 ↗
• MalfunctionFeb 18, 2026Failure to Fire

  IT WAS REPORTED THAT DURING AN OPEN HEMICOLECTOMY SURGERY, THE AFTER FIRING ONE RELOAD SUCCESSFULLY, THE NEXT RELOAD DID NOT FIRE AT ALL. THE SURGEON REPLACED THE HANDLE AND RELOAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24380797 ↗
• MalfunctionFeb 4, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE WHIPPLE PROCEDURE, THE SURGEON WAS ATTEMPTING TO CLAMP THE HANDLE OF THE DEVICE WHEN THE BLUE PLASTIC ON THE CARTRIDGE BROKE, RESULTING IN THE BROKEN PART DISENGAGING. NO PIECES FELL INTO THE PATIENT'S CAVITY. THE DEVICE WAS REPLACED BY A NEW RELOAD 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 24264467 ↗
• MalfunctionFeb 3, 2026Misfire

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE DEVICE WAS FIRED BUT THE RELOAD GOT STUCK MAKING THE STAPLE LINE INCOMPLETE DISTALLY. ANOTHER RELOAD WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24243402 ↗
• MalfunctionJan 23, 2026Component or Accessory Incompatibility; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, DURING SET-UP PRIOR TO SUBSEQUENT FIRING, THE CARTRIDGE COULD NOT BE LOADED, PREVENTING THE CLOSURE OF THE SAFETY MECHANISM. MULTIPLE DISASSEMBLY AND READJUSTMENT MANEUVERS WERE PERFORMED, BUT RESISTANCE TO CLOSURE PERSISTED. THE ATTEMPTS TO COMPLETE THE CLOSURE TO ENSURE FUNCTIONALITY RESULTED IN THE BLADE BEING DETACHED FROM THE FIRING SYSTEM, RENDERING THE DEVICE UNUSABLE. DUE TO THIS PRODUCT FAILURE, IT WAS NECESSARY TO DISCARD RECHARGING AND USE A NEW RELOAD TO COMPLETE THE PROCEDURE. THE SURGICAL TIME WAS EXTENDED FOR A FEW MINUTES DUE TO THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24166071 ↗
• MalfunctionJan 8, 2026Misfire

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE STAPLER PARTIALLY FIRED. THE STAPLER DID NOT FIRE COMPLETELY TO DISTAL END. ANOTHER CARTRIDGE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24005179 ↗
• MalfunctionJan 6, 2026Failure to Fire

  ACCORDING TO THE REPORTER, DURING A RIGHT HEMICOLECTOMY, THE DEVICE DID NOT FIRE FROM THE START. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23974837 ↗
• MalfunctionDec 25, 2025Misfire; Misfire

  IT WAS REPORTED THAT DURING THE PROCEDURE THE CARTRIDGE JAMMED HALFWAY THROUGH STAPLING.

  Patient problems: Insufficient Information

  MAUDE report 23891545 ↗
• MalfunctionDec 19, 2025Failure to Form Staple; Adverse Event Without Identified Device or Use Problem; Failure to Form Staple; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC RIGHT HEMICOLECTOMY, THE STAPLER WAS EMPLOYED FOR BOWEL TRANSECTION. THE DEVICE FIRED ALL THE WAY, BUT UPON INSPECTION OF THE STAPLE LINE, THE SURGEON IDENTIFIED THAT THE FIRST TWO STAPLE ROWS CONTAINED NO VISIBLE STAPLES, ALTHOUGH THE TISSUE HAD BEEN TRANSECTED. MILD BLEEDING WAS NOTED AT THE PORTION OF THE STAPLE LINE WHERE THE STAPLES HAD NOT DEPLOYED, AND SUTURING WAS PERFORMED DIRECTLY OVER THE AREA OF ABSENT STAPLES TO ACHIEVE HEMOSTASIS. DURING A SUBSEQUENT FIRING WITH A 2ND CARTRIDGE, MILD BLEEDING WAS AGAIN OBSERVED AT THE STAPLE LINE, WHICH WAS MANAGED BY AN ADDITIONAL STAPLER FIRING TO REINFORCE THE STAPLE LINE AND ACHIEVE HEMOSTASIS. NO FURTHER BLEEDING WAS OBSERVED FOLLOWING THESE INTERVENTIONS.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Tissue Breakdown

  MAUDE report 23854921 ↗
• MalfunctionDec 17, 2025Mechanics Altered; Mechanics Altered

  IT WAS REPORTED THAT DURING A PROCEDURE, THE TISSUE WAS NOT STAPLED. THE DEVICE WAS REPLACED WITH ANOTHER PRODUCT OF THE SAME REFERENCE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23834859 ↗
• MalfunctionDec 12, 2025Break; Break

  IT WAS REPORTED THAT DURING A PROCEDURE, THE INSTRUMENT BROKE. A NEW DEVICE WAS USED 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 23794516 ↗
• MalfunctionDec 11, 2025Break; Break

  IT WAS REPORTED THAT DURING A PROCEDURE, THE DEVICE BROKE. THE DEVICE WAS REPLACED WITH A NEW RELOAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23783315 ↗
• MalfunctionNov 27, 2025Break; Firing Problem; Break; Firing Problem

  IT WAS REPORTED THAT DURING USE OF THE STAPLER, THE RELOAD BROKE, THE DEVICE WAS DIFFICULT TO FIRE. THE DEVICE WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23667702 ↗
• MalfunctionNov 17, 2025Misfire; Misfire

  IT WAS REPORTED THAT DURING A PROCEDURE, THE TWO DEVICES DID NOT FIRE COMPLETELY TO THE DISTAL END. NO INTERVENTION WAS REQUIRED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23569671 ↗
• MalfunctionNov 17, 2025Misfire; Misfire

  IT WAS REPORTED THAT DURING A PROCEDURE, THE TWO DEVICES DID NOT FIRE COMPLETELY TO THE DISTAL END. NO INTERVENTION WAS REQUIRED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23569505 ↗