EEA TRIEEA31XTRecalls & reported problems

Summary

The FDA's MAUDE database contains 73 adverse event reports that list this exact device (DI 10884521593053), received between May 31, 2019 and Aug 5, 2026 — classified as 29 injuries, 44 malfunctions.

The most frequently reported specific device problem is “Failure to Form Staple” (19 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 73 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 5, 2026Mechanics Altered

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50148362 ↗
• MalfunctionMay 27, 2026Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROCEDURE, AFTER FIRING IT WAS DIFFICULT TO REMOVE THE STAPLER FROM THE CAVITY. DURING REMOVAL, THE ANVIL BECAME DISCONNECTED FROM THE CLAMP AND MANUAL EXTRACTION OF THE ANVIL AND FLANGES FROM THE RECTUM WAS REQUIRED. A SEAL TEST WAS PERFORMED AND WAS SUCCESSFUL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25296924 ↗
• MalfunctionMar 5, 2026Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, AFTER FIRING THE CIRCULAR STAPLER, WHEN THE STAPLER WAS ABOUT TO BE REMOVED FROM THE RECTUM AFTER FULLY TURNING THE KNOB TWICE AND HEARING A CLICK, THE ANVIL DETACHED FROM THE STAPLER. THE ANVIL SEEMED TO HAVE GOTTEN STUCK JUST BEFORE THE SPHINCTER. THE SURGEON TOOK OUT THE ANVIL THE OTHER WAY. THERE WAS NO ISSUE WITH THE ANASTOMOSIS AND THE DONUTS WERE COMPLETE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24517003 ↗
• InjuryFeb 10, 2026Failure to Form Staple; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC SIGMOIDECTOMY PROCEDURE, TEARING AND NON-CONNECTION OF THE BOWEL ENDS WERE OBSERVED UPON ACTIVATION OF THE STAPLES. EXAMINATION WITH A SCOPE REVEALED LOOSE STAPLES AND PARTIALLY FIRED STAPLES EMBEDDED IN TISSUE, AS WELL AS AN INCOMPLETE STAPLE LINE. ANASTOMOTIC LEAKAGE OCCURRED, AND THE PROCEDURE DURATION WAS EXTENDED BY APPROXIMATELY THREE HOURS WHILE THE PATIENT REMAINED UNDER SEDATION. THE STAPLER AND ITS PARTS WERE REMOVED AND SEQUESTERED. THERE WAS THE CREATION OF AN ILEOSTOMY. A REPLACEMENT STAPLER WAS USED SUCCESSFULLY. THE PATIENT REQUIRED HOSPITAL ADMISSION DUE TO THE COMPLICATION AND WILL NEED A SECOND SURGERY.

  Patient problems: Failure to Anastomose; Tissue Breakdown

  MAUDE report 24304601 ↗
• InjuryJan 14, 2026Failure to Form Staple

  IT WAS REPORTED THAT DURING A COLECTOMY WITH COLOSTOMY CLOSURE FOR NEOPLASIA PERFORMED BY LAPAROSCOPY, THE DEVICE WAS TIGHTENED AS USUAL WITH THE GREEN LIGHT VISIBLE, WAITING FOR 15 SECONDS TO ALLOW THE EDEMA TO DRAIN AND THEN TIGHTENING THE HANDLE FOR 30 SECONDS. HOWEVER, IT RESULTED IN NEAT MARGINS AFTER RESECTION BUT DID NOT ACHIEVE STAPLING. THERE WAS COMPLETE SEPARATION OF THE STAPLES, WITH BOTH THE COLONIC AND RECTAL PARTS REMAINING COMPLETELY OPEN. THE STAPLES WERE ALL OPEN IN A "U" SHAPE RATHER THAN THE EXPECTED "B" SHAPE. AS A RESULT, CONVERSION FROM LAPAROSCOPIC TO OPEN SURGERY WAS REQUIRED, AND MANUAL ANASTOMOSIS BY SUTURING WAS PERFORMED DUE TO THE INABILITY TO PERFORM ANOTHER MECHANICAL ANASTOMOSIS. THERE WAS ALSO A DELAY BY MORE THAN 30 MINUTES IN THE SURGICAL SCHEDULE. THE PATIENT EXPERIENCED PROLONGED HOSPITALIZATION AND RECEIVED ANTIBIOTIC TREATMENT.

  Patient problems: Failure to Anastomose; Tissue Breakdown

  MAUDE report 24072017 ↗
• MalfunctionDec 30, 2025Failure to Form Staple; Failure to Fire; Adverse Event Without Identified Device or Use Problem; Failure to Form Staple; Failure to Fire; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A COLORECTAL ANASTOMOSIS PROCEDURE, THE CIRCULAR STAPLER WAS UNABLE TO FIRE. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: Failure to Anastomose; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23931586 ↗
• InjuryDec 4, 2025Failure to Form Staple; Mechanics Altered; Failure to Form Staple; Mechanics Altered

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE CIRCULAR STAPLER CUT THE TISSUE BUT DID NOT DEPLOY SOME OF ITS STAPLES. THE ANASTOMOSIS WAS ONLY MADE PARTIALLY. ALONG THE HALF CIRCLE OF ANASTOMOSIS LINE THERE WERE NO STAPLES FOUND. THERE WERE NO STAPLES PRESENT IN THE CARTRIDGE. THE FAILED ANASTOMOSIS WAS RESECTED. ADDITIONAL MOBILIZATION WAS DONE. THERE WAS NO CHANCE FOR NEW ANASTOMOSIS, SO A TEMPORARY STOMA WAS IMPLEMENTED. THE PROCEDURE WAS EXTENDED FOR TWO HOURS DUE TO THE ISSUE. ANOTHER HARTMANN RECONSTRUCTION OPERATION IS NEEDED SOME MONTHS IN THE FUTURE.

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

  MAUDE report 23713508 ↗
• MalfunctionNov 10, 2025Human-Device Interface Problem; Human-Device Interface Problem

  IT WAS REPORTED THAT DURING A LOW ANTERIOR RESECTION, ALTHOUGH THE INDICATOR WINDOW WAS GREEN, THE SAFETY LEVER WOULD NOT RELEASE TO FIRE THE DEVICE. THE DEVICE WAS REMOVED AND REPLACED WITH ANOTHER STAPLER. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23519437 ↗
• MalfunctionNov 5, 2025Break; Break

  IT WAS REPORTED THAT PRE-OPERATIVELY, THE INSTRUMENT BROKE. THE DEVICE WAS REPLACED AND A NEW PRODUCT WAS USED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23476248 ↗
• MalfunctionOct 28, 2025Human-Device Interface Problem; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, DURING A RECTAL TUMOR WITH ANASTOMOSIS BETWEEN THE LEFT COLON AND RECTUM, THE RED SAFETY LEVER BLOCKED WHILE THE RECTAL STUMP WAS ALREADY PERFORATED THROUGH THE ANVIL TIP. THE SURGEON USED FORCE TO BREAK THE LEVER TO COMPLETE THE ANASTOMOSIS. SURGICAL TIME WAS EXTENDED BY 10 MINUTES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23403249 ↗
• MalfunctionOct 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A LOW ANTERIOR RESECTION, AFTER FIRING, A LEAK TEST WAS PERFORMED, AND THE RESULT WAS POSITIVE. THE SURGEON HAD TO OVERSEW THE STAPLE LINE TO COMPLETE THE CASE.

  Patient problems: Failure to Anastomose

  MAUDE report 23367314 ↗
• MalfunctionOct 21, 2025Mechanics Altered; Mechanics Altered

  IT WAS REPORTED THAT DURING USE OF THE CIRCULAR STAPLER, THE STAPLES DID NOT DEPLOY, RESULTING IN A CUT WITHOUT STAPLE FORMATION. THIS MADE COMPLETION OF THE COLORECTAL JUNCTION IMPOSSIBLE. TISSUE TEARS AND BLEEDING OCCURRED. THE DEVICE WAS REPLACED, AND SUTURING AND RE-STAPLING WERE PERFORMED TO COMPLETE THE OPERATION.

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

  MAUDE report 23345030 ↗
• MalfunctionJul 21, 2025Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC RECTOSIGMOIDECTOMY, THE DISCOID TECHNIQUE WAS USED, AND AFTER THE STAPLER WAS COMPLETELY CLOSED, IT WAS FIRED. WHEN THE STAPLER WAS OPENED, THERE WAS AN INCOMPLETE STAPLE LINE, LEAVING 1/4 OF THE INTESTINAL TUBE OPEN. THERE WAS ANASTOMOTIC LEAKAGE. RESECTION AND RE-STAPLING USING LINEAR STAPLING AND A NEW END-TO-END STAPLING WERE MADE TO RESOLVE THE ISSUE. THERE WAS EXTENDED SURGICAL TIME FOR ONE HOUR.

  Patient problems: Failure to Anastomose

  MAUDE report 22561794 ↗
• MalfunctionJul 18, 2025Failure to Form Staple; Adverse Event Without Identified Device or Use Problem; Failure to Form Staple; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A PROCTOCOLECTOMY, AFTER FIRING, THE POSTERIOR LINE WAS INCOMPLETE, AND THERE WAS A LEAK. A LEAK TEST RESULT WAS POSITIVE. ANOTHER SURGEON PERFORMED THE SUTURING AS STAPLE LINE REINFORCEMENT. THE SURGICAL TIME WAS EXTENDED BY 30 MINUTES.

  Patient problems: Failure to Anastomose

  MAUDE report 22543324 ↗
• InjuryJun 24, 2025Mechanics Altered; Mechanics Altered

  IT WAS REPORTED THAT DURING AN ANTERIOR RECTAL RESECTION, THE CIRCULAR STAPLER DID NOT TRIGGER OR STAPLE, IT ONLY CUT THE TISSUES, RESULTING IN THE INTESTINE REMAINING OPEN. TO RESOLVE THE ISSUE, THE RECTAL STUMP WAS SUTURED OVER AND A TERMINAL DESCENDING STOMA WAS CREATED. IT WAS NOTED THAT THE PROCEDURE WAS EXTENDED BY MORE THAN 30 MINUTES.

  Patient problems: Failure to Anastomose

  MAUDE report 22318981 ↗
• MalfunctionJun 16, 2025Device Slipped; Failure to Align; Device Slipped; Failure to Align

  IT WAS REPORTED THAT, DURING A RECTOSIGMOIDECTOMY, THERE WAS DIFFICULTY CLOSING THE CIRCULAR STAPLER BECAUSE TISSUES WERE NOT SETTLING PROPERLY IN THE DEVICE. THE LEAD SURGEON NOTICED THESE ISSUES BEFORE FIRING, REMOVED THE STAPLER FROM THE PATIENT TO CHECK FOR DISCONNECTION, AND OBSERVED THE TILTED ANVIL, MAKING THE STAPLER UNUSABLE. THE DEVICE WAS IMMEDIATELY REPLACED WITH ANOTHER OF THE SAME MODEL. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22216213 ↗
• MalfunctionJun 4, 2025Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING AN OPEN SIGMOIDECTOMY, USING THE 31 MILLIMETER EXTRA THICK CIRCULAR STAPLER, THE STAPLE LINE WAS INCOMPLETE, AND THE STAPLE DID NOT CLOSE PROPERLY. AFTER FIRING, IT WAS OBSERVED THAT ONLY PART OF THE POSTERIOR SURFACE WAS STAPLED, WHILE THE ANTERIOR SURFACE REMAINED OPEN. A MANUAL ANASTOMOSIS WAS PERFORMED USING A DIFFERENT MANUFACTURER'S SUTURE TO REPLACE THE STAPLE LINE, LEAVING THE ANASTOMOSIS END-TO-SIDE.

  Patient problems: Failure to Anastomose

  MAUDE report 22140918 ↗
• InjuryMay 29, 2025Detachment of Device or Device Component; Human-Device Interface Problem; Mechanics Altered; Detachment of Device or Device Component; Human-Device Interface Problem; Mechanics Altered

  ACCORDING TO THE REPORTER, IN A LOWER ANTERIOR RESECTION, THE SURGEON TURNED THE KNOB OF THE CIRCULAR STAPLER WHEN APPROXIMATING THE COLON FOR THE ANASTOMOSIS OF THE PROXIMAL AND DISTAL COLON. THE GREEN IN THE WINDOW WAS SEEN, BUT THE SAFETY LOCK WOULD NOT COME OFF. THE DEVICE WAS THEN FORCEDLY FIRED, AND A PIECE OF THE SAFETY BROKE OFF WHEN FIRING. THE STAPLES WERE ONLY DEPLOYED POSTERIORLY AND NOT ANTERIORLY, RESULTING IN AN INCOMPLETE STAPLE LINE. THE TISSUE WAS RESECTED AND RE-STAPLED WITH A SECOND CIRCULAR STAPLER FROM THE SAME LOT AND THE FIRING WENT SMOOTHLY. HOWEVER, THE DONUTS WERE NOT OPTIMAL AS THE SURGEON HAD TO GO MUCH LOWER WITH THE SECOND FIRING. THE BUBBLE LEAK TEST WAS NEGATIVE, BUT THE PATIENT WAS REQUIRED AN ADDITIONAL SURGERY.

  Patient problems: Failure to Anastomose

  MAUDE report 22106541 ↗
• MalfunctionMay 4, 2025Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT THE EEA ANVIL AND BODY DID NOT CLOSE PROPERLY. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INJURY.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21955861 ↗
• InjuryMar 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER. POST OPERATIVELY COLORECTAL ANASTOMOSIS, THERE WAS A FISTULA LEAK.

  Patient problems: Failure to Anastomose; Fistula

  MAUDE report 21730395 ↗
• MalfunctionMar 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POST OPERATIVELY OF A COLORECTAL ANASTOMOSIS, THERE WAS A FISTULA LEAK.

  Patient problems: Fistula

  MAUDE report 21627398 ↗
• MalfunctionFeb 26, 2025Device Slipped; Material Twisted/Bent; Device Slipped; Material Twisted/Bent

  ACCORDING TO THE REPORTER, DURING A LOWER ANTERIOR RESECTION, THE STAPLER WAS APPLIED THROUGH THE RECTUM; THE INSTRUMENT WAS OPENED TO VISUALIZE THE METAL BOLT. THE ANVIL WAS APPLIED ON THE BOLT, AND WHILE CLOSING THE STAPLER, THERE WAS SOME BIGGER EFFORT. AFTER THE STAPLER WAS OPENED, THE SURGEON NOTICED THAT ONE OF THE THREE METAL PARTS (PARTS OF THE ANVIL THAT WERE SUPPOSED TO SURROUND THE METAL BOLT) WAS BENT. THE SURGEON DECIDED TO REPLACE THE STAPLER WITH THE SAME LOT NUMBER TO RESOLVE THE ISSUE. THE SURGICAL TIME WAS EXTENDED TO 20 MINUTES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21469843 ↗
• InjuryJan 23, 2025Failure to Form Staple; Adverse Event Without Identified Device or Use Problem; Failure to Form Staple; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE FIRST STAPLER WITH A 31 MM DIAMETER WAS USED, BUT THE DEVICE FIRED THE STAPLES ONLY PARTIALLY, LEAVING SOME INSIDE THE ANVIL, WHICH RESULTED IN A LEAK IN THE COLON. A SECOND STAPLER WITH A 28 MM DIAMETER WAS EMPLOYED TO CORRECT THE ISSUE. HOWEVER, AFTER FIRING, ANOTHER LEAK WAS MADE. THE SURGEON HAD TO PERFORM SUTURING MANUALLY TO RESOLVE THE ISSUE. THERE WAS EXTENDED HOSPITALIZATION.

  Patient problems: Failure to Anastomose; Tissue Breakdown

  MAUDE report 21218705 ↗
• MalfunctionJan 14, 2025Misfire; Misfire

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE DEVICE HAD FIRING ISSUES. THE FIRING WAS FAULTY. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21148813 ↗
• MalfunctionDec 11, 2024Failure to Align; Incomplete or Inadequate Connection; Failure to Align; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT DURING A ROBOTIC SURGERY TO TREAT DEEP ENDOMETRIOSIS INVOLVING A CIRCULAR STAPLER, THE INSTRUMENT BROKE AS THE WARHEAD OF THE STAPLER ARTICULATED AND WOULD NOT RETURN, MAKING IT IMPOSSIBLE FOR THE SURGEON TO CLOSE THE STAPLER TO PERFORM THE STAPLING. THIS ISSUE OCCURRED RIGHT AT THE BEGINNING, AS SOON AS THE STAPLER WAS INTRODUCED. TO RESOLVE THE ISSUE, THE SURGEON REQUESTED A REPLACEMENT WITH ANOTHER STAPLER, WHICH FUNCTIONED CORRECTLY AND STAPLED PERFECTLY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20902033 ↗