EEA TRIEEAXL28MTRecalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 10884521593121), received between Aug 4, 2021 and Sep 22, 2026 — classified as 7 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (5 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Failure to Anastomose

  MAUDE report 50859907 ↗
• MalfunctionMar 10, 2026Failure to Form Staple

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC SIGMOID COLON RESECTION, WHILE PERFORMING AN END-TO-END ANASTOMOSIS OF THE DISTAL COLON THE STAPLE LINE WAS INCOMPLETE, REQUIRING THE SURGEON TO RE-TRANSECT THE DISTAL COLON, PLACE ANOTHER ANVIL, AND USE A SECOND CIRCULAR STAPLER. THE SURGICAL TIME WAS EXTENDED BY 25 MINUTES. CIRCULAR STAPLER SIZERS WERE USED.

  Patient problems: Failure to Anastomose

  MAUDE report 24554655 ↗
• MalfunctionFeb 27, 2026No Device Output; Device Slipped

  IT WAS REPORTED THAT DURING A PROCEDURE, A CIRCULAR STAPLER WAS INSERTED THROUGH THE PREVIOUSLY PREPARED DISTAL INTESTINAL SEGMENT (ANORECTAL). THE OPENING OF THE INTEGRATED TROCAR OF THE CIRCULAR STAPLER WAS INITIATED BY MANIPULATING THE ROTARY KNOB TO THE OPEN POSITION. IT WAS OBSERVED THAT MORE TURNS THAN USUAL WERE REQUIRED TO VISUALIZE THE TIP OF THE TROCAR, AND THE MANIPULATION FELT UNUSUAL. THE DEVICE WAS REMOVED FROM THE SURGICAL SITE AND A OPEN AND CLOSE TEST WAS PERFORMED, CONFIRMING IRREGULAR BEHAVIOR OF THE DEVICE. THE DEVICE WAS NOT USED, AND ANOTHER UNIT OF THE PRODUCT WAS REQUESTED AND USED INSTEAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24470304 ↗
• InjuryJan 22, 2026Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POST-OPERATIVE OF A PROCEDURE WHERE TWO POWERED CIRCULAR STAPLER RELOADS WERE USED, THE PATIENT HAD STRICTURE.

  Patient problems: Stenosis

  MAUDE report 24152121 ↗
• InjuryOct 21, 2025Mechanics Altered; Mechanics Altered

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC LEFT COLON RESECTION WITH ENHANCED RECOVERY AFTER SURGERY (ERAS) AND RECTOPEXY, THERE WERE FIRING ISSUES WITH THE CIRCULAR STAPLER WHILE RECONNECTING THE RECTUM WITH THE LEFT COLON AFTER RESECTION. THE STAPLER WAS CLOSED AND THE GREEN BAR INDICATED THE TISSUE WAS COMPRESSED TO FIRING RANGE, BUT WHEN FIRED, NO STAPLES WERE VISIBLY DEPLOYED IN THE TISSUE OR ABDOMEN. THE KNIFE BLADE CUT THE RECTAL AND COLON TISSUE WITHOUT DEPLOYING STAPLES, RESULTING IN HOLES IN THE BOWEL STUMPS. THE PROCEDURE WAS EXTENDED BY 30 MINUTES. TO ADDRESS THE DEFECTS, SUTURING WAS PERFORMED TO CLOSE THE HOLES, ANOTHER ANVIL WAS SEWN IN FOR SUBSEQUENT STAPLING, AND THE TISSUE WAS RESECTED AND RE-STAPLED. THE DEVICE WAS REPLACED WITH ANOTHER OF THE SAME MODEL, AND AN ANASTOMOSIS WAS SUCCESSFULLY CREATED WITH THE REPLACEMENT STAPLER.

  Patient problems: Failure to Anastomose

  MAUDE report 23349204 ↗
• MalfunctionApr 4, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING A CIRCULAR STAPLER, THE STAPLER WAS FIRED COMPLETELY WITH NO SIGNS OF LEAKAGE AS CONFIRMED BY SIGMOIDOSCOPY. HOWEVER, UPON REMOVAL OF THE STAPLER FROM THE RECTUM, THE ANVIL REMAINED BEHIND. THE SURGEON SUCCESSFULLY RETRIEVED THE ANVIL FROM THE RECTUM. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21775549 ↗
• MalfunctionApr 1, 2025Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A ROBOT-ASSISTED LAP SIGMOIDECTOMY WITH A SIGMOID/RECTAL ANASTOMOSIS, THERE WERE ISSUES AFTER FIRING THE EEA/HEM STAPLER. THE SPECIFIC PROBLEMS INCLUDED ANVIL ISSUES WITH THE STAPLER, DIFFICULTY IN REMOVING THE ANVIL FROM THE CAVITY AND THE ANVIL BEING DISPLACED AFTER OVERTURNING. THE SURGEON TURNED THE BLACK LEVER TO THE LEFT FOR TWO FULL 360 DEGREE TURNS UNTIL A CLICK WAS HEARD, AND CONTINUED TO TURN UNTIL THE ANVIL WAS DISPLACED AFTER OVERTURNING. THE SURGEON HAD TO MANUALLY REMOVE THE ANVIL WITH HANDS UP THE RECTUM. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21737244 ↗
• MalfunctionMar 17, 2025

  SURGEON HAS A SCHEDULED ROBOTIC COLOSTOMY TAKEDOWN AND DURING THE COLON ANASTOMOSIS PART OF CASE, WE WERE USING THE COVIDIEN CIRCULAR STAPLER (TRIEEAXL28MT). AFTER ANASTOMOSING THE COLON, THE FIRST ASSIST WAS INSTRUCTED TO RETRACT AND REMOVE THE STAPLER BUT WAS HAVING DIFFICULTY PULLING THE WHOLE DEVICE OUT OF THE COLON. THE STAFF COULD SEE ON THE VIDEO MONITOR AS WELL THAT THERE IS SOME RESISTANCE. SURGEON SWITCH POSITION WITH THE FIRST ASSIST TO REMOVE THE CIRCULAR STAPLER HIMSELF AND WAS ABLE TO DO SO, BUT THE ANVIL PART OF THE DEVICE WAS LODGED INSIDE THE COLON. WE UTILIZED THE GI CART AND SCOPE TO TRY TO REMOVE THE ANVIL. SURGEON WAS ABLE TO REMOVE THE ANVIL OUT OF THE COLON THROUGH THE RECTUM AND OUT OF THE ANUS. THE ANVIL CONTAINED TWO COMPLETE ANASTOMOSIS RINGS WHICH WAS SENT TO PATHOLOGY PER SURGEON. THE COVIDIEN CIRCULAR STAPLER INCLUDING THE ANVIL WAS SAVE AND WAS GIVEN TO OR SUPERVISOR. THE PROCEDURE PROCEEDED WITHOUT FURTHER ISSUES AND THE PATIENT WAS BROUGHT TO PACU AFTER THE CASE WAS FINISHED.

  Patient problems: Insufficient Information

  MAUDE report 21618359 ↗
• MalfunctionJan 23, 2025Failure to Align; Failure to Fire; Human-Device Interface Problem; Failure to Align; Failure to Fire; Human-Device Interface Problem

  ACCORDING TO THE REPORTER DURING THE COLON WEDGE RESECTION FOR ENDOMETRIOSIS, THE DEVICE WAS NOT ABLE TO FIRE. THE TILT TOP MECHANISM OF THE ANVIL OF THE STAPLER WAS ACTIVATED, WITHOUT THE DEVICE HAVING BEEN TRIGGERED. AS A RESOLUTION, ANOTHER CIRCULAR STAPLER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21218670 ↗
• MalfunctionJul 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A SIGMOID COLECTOMY PROCEDURE, AFTER FIRING THE DEVICE, THE SURGEON THEN HELD PRESSURE FOR A PERIOD OF TIME AND THEN RELEASED AND REMOVED THE STAPLER. ALTHOUGH THE DONUTS WERE INSPECTED AND FOUND TO BE FINE AND WHOLE, THE STAPLE LINE ESSENTIALLY PULLED APART IMMEDIATELY UPON WITHDRAWAL OF THE STAPLER. THE SURGEON SUTURED THE STAPLE LINE TO RESOLVE THE ISSUE.

  Patient problems: Failure to Anastomose; Tissue Breakdown

  MAUDE report 19706237 ↗
• MalfunctionJul 9, 2024Misfire; Noise, Audible; Misfire; Noise, Audible

  ACCORDING TO THE REPORTER, DURING A ROBOTIC LAPAROSCOPIC COLOSTOMY REVERSAL PROCEDURE, AFTER FIRING AND TURNING THE BLACK KNOB 2 FULL TURNS AT THE TIME OF COLOSTOMY REVERSAL, THE SURGEON DID NOT HEAR A CLICK SOUND. IT WAS ALSO OBSERVED THAT THE TISSUE DONUT WAS NOT COMPLETELY FORMED AND WAS STILL ATTACHED TO THE ANASTOMOSIS. TO RESOLVE THE ISSUE, THE SURGEON REMOVE THE PORTION OF THE INCOMPLETE DONUT THAT WAS LEFT BEHIND IN THE ANASTOMOSIS. THIS LED TO EXTENDED SURGICAL TIME.

  Patient problems: Tissue Breakdown

  MAUDE report 19702793 ↗
• MalfunctionApr 24, 2024Detachment of Device or Device Component; Expulsion; Detachment of Device or Device Component; Expulsion

  ACCORDING TO THE REPORTER, PREOPERATIVELY, THE STAPLES WERE EXPOSED AND COMPONENT DISENGAGED. IT WAS NOTED THAT STAPLES WERE STICKING OUT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19174336 ↗
• MalfunctionMar 8, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING ANASTOMOSIS, PLACEMENT OF THE SUTURE IN THE DESIRED POSITION IN THE ANASTOMOSIS TISSUE WAS PERFORMED BUT THE DEVICE DID NOT FIRE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18871136 ↗
• MalfunctionFeb 6, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  ACCORDING TO THE REPORTER, THE STAPLER AND ANVIL COULD NOT BE ASSEMBLED. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18651372 ↗
• InjuryMay 22, 2023Mechanics Altered; Mechanics Altered

  ACCORDING TO THE REPORTER, DURING A REVERSAL OF HARTMANN'S PROCEDURE, WHILE FIRING, THE KNIFE BLADE STILL CUT BUT NO STAPLES WERE FIRED. SURGICAL INTERVENTION WAS NEEDED TO PREVENT A PERMANENT IMPAIRMENT OF A FUNCTION. THERE WAS BLOOD LOSS OF ABOUT 300 ML AS RECTAL STUMP IN THE PELVIS AND THE SURGEON HAD TO GET THE PROXIMAL PART OF THE BOWEL OUT BEFORE AND CONTAMINATION AND THEN CAME BACK TO PELVIS. THE OPERATION WAS EXTENDED BY 2.5 HOURS. THE SURGEON HAD TO MAKE A LARGE PFANNENSTIEL INCISION AND SUTURE IN THE PELVIS DUE TO THE DEVICE ISSUE. ANOTHER DEVICE WAS OPENED TO RESOLVE THE ISSUE.

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

  MAUDE report 16978745 ↗
• MalfunctionFeb 6, 2023Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, THE ANVIL DISENGAGED AND FELL OFF INTO THE PATIENT CAVITY. THE SURGICAL TIME WAS EXTENDED FOR MORE THAN 30 MINUTES OR MORE AS A RESULT. A PROCTOSCOPE WAS USED TO RETRIEVE THE ANVIL AND RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16304967 ↗
• InjurySep 14, 2022Misfire; Failure to Form Staple; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Misfire; Failure to Form Staple; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC COLOSTOMY TAKEDOWN, WHILE ANASTOMOSING THE SIGMOID COLON, WHEN THE SAFETY WAS RELEASED, IT BROKE OFF IN THE SA'S (SURGEON ASSISTANT) HANDS. FIRING STILL COMMENCED AND IT WAS DISCOVERED THAT ONE SIDE OF THE DEVICE'S STAPLES CUT BUT DID NOT FIRE STAPLES. SIGMOIDOSCOPE WAS USED WHICH DETERMINED THAT THE DEVICE PARTIALLY FIRED WITHIN THE TISSUE. THE DONUTS WERE INCOMPLETE. THE SURGEON PERFORMED ANOTHER RESECTION AND ANASTOMOSED THE TISSUE WITH A NEW DEVICE. THIS LED TO TISSUE LOSS AND 30 MINUTES OR MORE EXTENDED SURGICAL TIME. THE PATIENT IS ALIVE.

  Patient problems: Failure to Anastomose; Unspecified Tissue Injury

  MAUDE report 15419609 ↗
• InjuryAug 22, 2022Failure 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 LAPAROSCOPIC SIGMOID RESECTION, ON CIRCULAR ANASTOMOSIS, DONUTS WERE COMPLETE UPON INSPECTION. PRIOR TO THE LEAK TEST, THE SURGEON NOTICED THERE WAS NO STAPLE FORMATION IN THE ANTERIOR PORTION OF THE STAPLE LINE. THE PATIENT EXPERIENCED UNANTICIPATED LOSS AND TISSUE DAMAGE. THE SURGICAL TIME WAS EXTENDED FOR 30 MINUTES. THE INITIAL ANASTOMOSIS HAD TO BE TAKEN DOWN, ADDITIONAL TISSUE WAS NEEDED TO BE RESECTED AND RE-STAPLED. A SECOND ANASTOMOSIS WAS COMPLETED SUCCESSFULLY TO RESOLVE THE ISSUE.

  Patient problems: Failure to Anastomose; Unspecified Tissue Injury

  MAUDE report 15272482 ↗
• MalfunctionMar 8, 2022Misfire; Misfire

  ACCORDING TO THE REPORTER, DURING A ROBOTIC LAPAROSCOPIC LOW ANTERIOR RESECTION, ON ANASTOMOSIS, THERE WAS A TORN OR INCOMPLETE PROXIMAL TISSUE DONUT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13697665 ↗
• MalfunctionAug 27, 2021Misfire; Misfire

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC LOW ANTERIOR COLON RESECTION, ONE OF THE TWO DONUTS WAS INCOMPLETE. LEAK TEST WAS DONE AND WAS NEGATIVE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12380883 ↗
• InjuryAug 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, ONE MONTH POSTOPERATIVE FROM ROBOTIC LAPAROSCOPIC SIGMOIDECTOMY, THE PATIENT HAD BLOOD IN THE STOOL. THE PATIENT HAD TO BE SCOPED AND FOUND THE ANASTOMOSIS LOOKED RED AND FRESH BUT STAPLE LINE WAS INTACT AND NO ACTIVE BLEEDING NOTED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 12278026 ↗
• InjuryAug 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, 2 DAYS POST-OPERATIVE, PATIENT DEVELOPED BLEEDING FROM THE ANUS. LAPAROSCOPIC ROBOTIC SIGMOIDECTOMY WENT FINE. ANASTOMOSIS WAS TESTED AND THERE WERE NO LEAKS. TISSUE DONUTS WERE COMPLETE AND THICK. CASE WAS COMPLETED WITHOUT PRODUCT CONCERN. PATIENT HOSPITALIZATION WAS EXTENDED BY 1 MORE DAY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12275572 ↗