EEA TRIEEA33XTRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10884521593077), received between Jun 2, 2023 and Apr 30, 2026 — classified as 2 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Failure to Form Staple” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 30, 2026Failure to Form Staple

  IT WAS REPORTED THAT DURING A SEGMENTAL BOWEL RESECTION, THERE WAS AN INCOMPLETE STAPLE LINE. RESECTION LINE WAS SUTURED TO RESOLVE THE ISSUE.

  Patient problems: Tissue Breakdown

  MAUDE report 25043711 ↗
• MalfunctionApr 29, 2026Failure to Form Staple

  IT WAS REPORTED THAT DURING A SEGMENTAL BOWEL RESECTION, THERE WAS AN INCOMPLETE STAPLE LINE. SUTURING WAS PERFORMED TO RESOLVE THE ISSUE.

  Patient problems: Failure to Anastomose

  MAUDE report 25031454 ↗
• MalfunctionNov 24, 2025Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING A VIDEO LAPAROSCOPIC PROCEDURE FOR THE MANAGEMENT OF DEEP INTESTINAL ENDOMETRIOSIS, THE CIRCULAR STAPLER CORRECTLY APPLIED; HOWEVER, THE DEVICE FAILED TO STAPLE THE INTESTINAL SEGMENT. THE INTESTINAL SEGMENT REMAINED COMPLETELY OPEN. MANUAL SUTURING WAS PERFORMED, FOLLOWED BY A NEW STAPLING WITH CIRCULAR STAPLER.

  Patient problems: Failure to Anastomose

  MAUDE report 23636761 ↗
• MalfunctionOct 19, 2025Failure to Align; Failure to Align

  IT WAS REPORTED THAT DURING A PROCEDURE, THE ANVIL WAS LOCKED IN OPEN POSITION BEFORE STAPLING, AND WAS RENDERED UNUSABLE. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23334114 ↗
• MalfunctionAug 15, 2025Failure to Form Staple; Detachment of Device or Device Component; Failure to Form Staple; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, DURING THE FIRING THE STAPLER THE KNIFE WAS CUTTING BUT THE STAPLES FELL OFF THE STAPLER.  ANOTHER DEVICE WAS USED TO COMPLETE THE CASE.

  Patient problems: Failure to Anastomose

  MAUDE report 22819759 ↗
• InjuryOct 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A PRIMARY ANASTOMOSIS PROCEDURE, THERE WAS NO ISSUE WITH THE DEVICE. THE PROXIMAL AND DISTAL DONUTS WERE INSPECTED AND APPEARED COMPLETED. TWO DAYS LATER, WHEN COMPLETING THE WARD ROUND, THERE WERE FECES IN THE DRAIN. THE PATIENT WAS TAKEN BACK TO THE THEATER. THE SURGEON COMPLETED THREE LEAK TESTS DURING THIS, AND NO AIR BUBBLES OR LEAK POINTS WERE IDENTIFIED. HOWEVER, THERE WAS A SMALL AMOUNT OF FECES IN THE ABDOMEN ON THE RETRACTOR. THE ANASTOMOSIS WAS TAKEN DOWN, AND A COLOSTOMY WAS DONE. FOLLOW-UP COMPUTED TOMOGRAPHY (CT) SCAN SHOWED NO IDENTIFIABLE PELVIC COLLECTION BUT HAS A WOUND INFECTION. A NEGATIVE PRESSURE WOUND THERAPY SYSTEM DRESSING WAS APPLIED. THE PATIENT WAS FINE AND IS RECOVERING.

  Patient problems: Failure to Anastomose; Post Operative Wound Infection; Unintended Radiation Exposure

  MAUDE report 20471202 ↗
• InjuryJun 2, 2023Detachment of Device or Device Component; Material Twisted/Bent; Adverse Event Without Identified Device or Use Problem; Detachment of Device or Device Component; Material Twisted/Bent; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A RECTOSIGMOIDECTOMY, THE SURGEON WAS ABLE TO CLOSE THE STAPLE LINE HOWEVER WHEN THE STAPLER WAS REMOVED THE ANVIL DETACHED IN THE RECTUM AND DAMAGED THE ANASTOMOSIS. THE SURGEON DID THE 4 AND 1/2 TURNS CORRECTLY AND THE ANVIL TILTED AND THEY WERE ABLE TO REMOVE THE ANVIL. THE SURGICAL TIME WAS EXTENDED BY MORE THAN 30 MINUTES AS THE ANASTOMOSIS HAD TO BE REDONE VIA MANUAL SUTURING. THERE WAS EXTENDED PATIENT HOSPITALIZATION, AND A TEMPORARY COLOSTOMY BAG HAD TO BE ATTACHED TO THE PATIENT DUE TO THE ISSUE. IT WAS ALSO REPORTED THAT THE ANVIL BENT.

  Patient problems: Failure to Anastomose

  MAUDE report 17052020 ↗