EEA TRIEEA28XTRecalls & reported problems

Summary

The FDA's MAUDE database contains 220 adverse event reports that list this exact device (DI 10884521593039), received between Sep 25, 2018 and Sep 15, 2026 — classified as 103 injuries, 117 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (51 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 25 most recent of 220 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2026Incomplete or Inadequate Connection

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50776322 ↗
• MalfunctionSep 15, 2026Detachment of Device or Device Component

  It was reported that during a recto-colic termino-terminal circular stapling, the anvil remained in the rectum when the surgeon unscrewed and removed the stapler. A click was noted during connection between the anvil and stapler; all other handling was reported as usual until extraction. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50766613 ↗
• MalfunctionJul 30, 2026Difficult to Remove; Material Twisted/Bent

  Patient problems: Failure to Anastomose; Tissue Breakdown

  MAUDE report 50086709 ↗
• MalfunctionJul 6, 2026Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, A PIECE FROM THE CIRCULAR STAPLER BROKE OFF. THE SURGEON RETRIEVED ALL THE PIECES. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25715177 ↗
• MalfunctionApr 29, 2026Misfire

  ACCORDING TO THE REPORTER, THE CIRCULAR STAPLER MISFIRED.

  Patient problems: Insufficient Information

  MAUDE report 25038364 ↗
• MalfunctionApr 21, 2026Misfire; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING A PROCEDURE, THE DEVICE HAD A USE FAILURE. 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 24943125 ↗
• MalfunctionMar 30, 2026Break

  IT WAS REPORTED THAT PREOPERATIVELY, THE INSTRUMENT BROKE. THE DEVICE WAS REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24714527 ↗
• InjuryMar 20, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC LOW ANTERIOR RESECTION (LAR) CONVERTED TO OPEN WHICH UNRELATED TO THE DEVICE PROBLEM, THE CIRCULAR STAPLER WAS APPLIED AT THE RECTUM/SIGMOID. APPROXIMATELY SIX DAYS AFTER SURGERY, AN ANASTOMOTIC LEAK OCCURRED POSTOPERATIVELY. THE PATIENT EXPERIENCED POSTOPERATIVE PAIN AT THE SURGICAL SITE AND REQUIRED EXTENDED HOSPITALIZATION. THE ANASTOMOTIC LEAK WAS TREATED WITH MEDICATIONS.

  Patient problems: Failure to Anastomose; Pain

  MAUDE report 24646710 ↗
• InjuryMar 20, 2026Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER FOLLOWING LAPAROSCOPIC LOW ANTERIOR RESECTION, THERE WAS A LEAKAGE ON THE ANASTOMOSIS OF THE SIGMOID/RECTUM AND A HEMATOMA. THE HOSPITALIZATION WAS EXTENDED.

  Patient problems: Hematoma; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24646675 ↗
• MalfunctionMar 19, 2026Misfire

  IT WAS REPORTED THAT DURING USE OF THE CIRCULAR STAPLER, THERE WAS A FAILURE. THE DEVICE WAS REPLACED WITH A NEW PRODUCT. NO CONSEQUENCES OR IMPACT TO THE PATIENT HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24637649 ↗
• MalfunctionMar 13, 2026Misfire

  IT WAS REPORTED THAT DURING A ROBOTIC LOW ANTERIOR RESECTION (LAR) PROCEDURE, THE DISTAL DONUT WAS FOUND TO BE INCOMPLETE. THE STAPLE LINE WAS INSPECTED AND APPEARED TO BE COMPLETE, AND A LEAK TEST WAS CONDUCTED, WHICH PASSED. 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 24599000 ↗
• MalfunctionMar 10, 2026Failure to Form Staple; Mechanics Altered

  ACCORDING TO THE REPORTER DURING A RECTAL CANCER SURGERY, A PARTIAL DISRUPTION OF THE STAPLE LINE WAS OBSERVED AFTER FIRING THE CIRCULAR STAPLER. APPROXIMATELY HALF OF THE STAPLE LINE HAD OPENED. ON VISUAL INSPECTION, IT APPEARED THAT ONLY TWO ROWS OF STAPLES WERE PROPERLY DEPLOYED. SURGICAL TIME WAS EXTENDED BY 10 MINUTES. A NEW STAPLER FROM A COMPETITOR WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Failure to Anastomose

  MAUDE report 24555877 ↗
• MalfunctionFeb 20, 2026Failure to Align

  IT WAS REPORTED THAT DURING A PROCEDURE, WHEN THE SPECIALIST INTRODUCED THE CIRCULAR STAPLER, THE ANVIL WAS NORMAL; HOWEVER, UPON REMOVAL TO ADJUST THE STAPLER AND THE SITE OF THE ANASTOMOSIS, THE ANVIL APPEARED CROOKED AS IF IT HAD BEEN FIRED. THE STAPLER 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 24400968 ↗
• MalfunctionFeb 9, 2026Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING ANASTOMOSIS PROCEDURE, THE ANVIL BECAME LODGED AT THE ANASTOMOTIC SITE AFTER FIRING. THE ANVIL COULD NOT BE DISENGAGED, AND THE FIRING TWIST KNOB WAS ROTATED MORE THAN THE RECOMMENDED TWO AND A HALF TURNS. THE ANVIL SEPARATED FROM THE STAPLER BODY WHILE REMAINING LODGED AT THE ANASTOMOTIC SITE, AND THE DETACHED ANVIL FELL INTO THE PATIENT CAVITY. REMOVAL OF THE DETACHED ANVIL WAS UNSUCCESSFUL, AND ADDITIONAL BOWEL RESECTION WAS REQUIRED. THE PROCEDURE TIME WAS EXTENDED BY APPROXIMATELY 40 MINUTES. ALL PIECES WERE EVENTUALLY RETRIEVED. THE ISSUE WAS RESOLVED BY RESECTING AND RE-STAPLING THE AFFECTED AREA.

  Patient problems: Tissue Breakdown

  MAUDE report 24290222 ↗
• MalfunctionFeb 4, 2026Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING A COLORECTAL ANASTOMOSIS, THE STAPLES DID NOT CLOSE SO THE ANASTOMOSIS FAILED; HOWEVER, THE TISSUE DONUT WAS COMPLETE. TO RESOLVE THE ISSUE, A COMPLETE REVISION OF THE SURGICAL PART WAS PERFORMED AND A SECOND CIRCULAR STAPLER WAS USED. THE SURGICAL TIME WAS DELAYED BY MORE THAN THIRTY MINUTES AS A RESULT OF THE EVENT.

  Patient problems: Failure to Anastomose

  MAUDE report 24256869 ↗
• InjuryJan 23, 2026Difficult to Remove; Detachment of Device or Device Component; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC PROCEDURE, RESISTANCE WAS ENCOUNTERED WHEN ATTEMPTING TO REMOVE THE DEVICE FROM THE RECTUM, RESULTING IN THE ANVIL REMAINING STUCK INSIDE THE RECTUM. THE ANVIL WAS FOUND TO BE BENT. THESE ISSUES NECESSITATED CONVERSION FROM LAPAROSCOPIC TO OPEN SURGERY.

  Patient problems: Failure to Anastomose; Laceration(s)

  MAUDE report 24164010 ↗
• MalfunctionJan 20, 2026Failure to Align

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC SIGMA RESECTION PROCEDURE, THE ANVIL WAS FOUND TILTED WHEN IT WAS TAKEN OUT OF THE PACKAGE PRIOR TO USE. THE DEVICE WAS REPLACED WITH ANOTHER INSTRUMENT TO CONTINUE THE OPERATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24121073 ↗
• InjuryJan 14, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING A LOW ANTERIOR RESECTION PROCEDURE INVOLVING THE CIRCULAR STAPLER, LEAKAGE WERE CONFIRMED AT THE ANAS TOMOTIC SITE. AS A RESULT, THE PATIENT REQUIRED READMITTANCE TO THE HOSPITAL. SUTURING WAS PERFORMED AS A STAPLE LINE REPLACEMENT TO ADDRESS THE LEAKAGE.

  Patient problems: Failure to Anastomose; Tissue Breakdown

  MAUDE report 24073402 ↗
• InjuryJan 14, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING A LOW ANTERIOR RESECTION PROCEDURE INVOLVING THE CIRCULAR STAPLER, LEAKAGE WERE CONFIRMED AT THE ANAS TOMOTIC SITE. AS A RESULT, THE PATIENT REQUIRED READMITTANCE TO THE HOSPITAL. SUTURING WAS PERFORMED AS A STAPLE LINE REPLACEMENT TO ADDRESS THE LEAKAGE.

  Patient problems: Failure to Anastomose; Tissue Breakdown

  MAUDE report 24073373 ↗
• MalfunctionDec 25, 2025Failure to Align; Failure to Align

  IT WAS REPORTED THAT DURING A LEFT COLECTOMY, THE CIRCULAR STAPLER ANVIL ROCKING/ TILTED BEFORE THE STAPLING MECHANISM WAS ACTIVATED. THE DEVICE WAS REPLACED WITH ANOTHER DEVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23892362 ↗
• MalfunctionDec 24, 2025Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ANASTOMOSIS PROCEDURE USING THE CIRCULAR STAPLER, THE ANVIL DISENGAGED, AND THE TIP OF THE STAPLER REMAINED IN THE COLON. DESPITE COMPLETE CLOSURE AND A GREEN SIGNAL FROM THE STAPLER, IT WAS NECESSARY TO REMOVE THE SPECIMEN AGAIN AND PERFORM A NEW ANASTOMOSIS. AN ADDITIONAL 5 CM OF COLON WAS LOST FOR THE PATIENT, AND A LOOP OF THE COLON HAD TO BE DISSECTED TO GAIN ADDITIONAL LENGTH UP TO THE ANUS.

  Patient problems: Failure to Anastomose; Tissue Breakdown

  MAUDE report 23888215 ↗
• InjuryDec 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING A LOW ANTERIOR RESECTION PROCEDURE INVOLVING THE CIRCULAR STAPLER, THE PATIENT VISITED THE EMERGENCY ROOM DUE TO A LEAKAGE ISSUE AND REQUIRED AN EMERGENCY OPERATION. ANASTOMOSIS LEAKS WERE CONFIRMED AT THE ANASTOMOTIC SITE. AS A RESULT, THE PATIENT REQUIRED READMITTANCE TO THE HOSPITAL. SUTURING WAS PERFORMED AS A STAPLE LINE REPLACEMENT TO ADDRESS THE LEAKAGE.

  Patient problems: Failure to Anastomose; Tissue Breakdown

  MAUDE report 23873258 ↗
• InjuryDec 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING AN ANTERIOR RESECTION (AR) PROCEDURE INVOLVING THE CIRCULAR STAPLER, POSTOPERATIVE ANASTOMOSIS LEAKS WERE CONFIRMED AT THE ANASTOMOTIC SITE. AS A RESULT, THE PATIENT REQUIRED READMITTANCE TO THE HOSPITAL AND UNDERWENT REOPERATION. SUTURING WAS PERFORMED AS A STAPLE LINE REPLACEMENT TO ADDRESS THE LEAKAGE.

  Patient problems: Failure to Anastomose; Tissue Breakdown

  MAUDE report 23873171 ↗
• InjuryDec 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING A LOW ANTERIOR RESECTION (LAR) PROCEDURE INVOLVING THE CIRCULAR STAPLER, POSTOPERATIVE ANASTOMOSIS LEAKS WERE CONFIRMED AT THE ANASTOMOTIC SITE. AS A RESULT, THE PATIENT REQUIRED READMITTANCE TO THE HOSPITAL AND UNDERWENT REOPERATION. SUTURING WAS PERFORMED AS A STAPLE LINE REPLACEMENT TO ADDRESS THE LEAKAGE.

  Patient problems: Failure to Anastomose; Tissue Breakdown

  MAUDE report 23873127 ↗
• InjuryDec 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SIX DAYS FOLLOWING THE LOW ANTERIOR RESECTION PROCEDURE INVOLVING THE CIRCULAR STAPLER, POST-OPERATIVE ANASTOMOSIS LEAKS WERE CONFIRMED AT THE ANASTOMOTIC SITE. AS A RESULT, THE PATIENT REQUIRED READMITTANCE TO THE HOSPITAL AND UNDERWENT REOPERATION. SUTURING WAS PERFORMED AS A STAPLE LINE REPLACEMENT TO ADDRESS THE LEAKAGE.

  Patient problems: Failure to Anastomose; Laceration(s); Tissue Breakdown

  MAUDE report 23858103 ↗