EEA TRIEEAXL28XTRecalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 10884521593138), received between Jun 2, 2021 and Apr 7, 2026 — classified as 12 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Failure to Form Staple” (9 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 28 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 7, 2026Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING A ROBOTIC LAPAROSCOPIC LOW ANTERIOR RESECTION, DURING ANASTOMOSIS, THE ANVIL AND RELOAD OF THE CIRCULAR STAPLER WERE FULLY CONNECTED BUT THERE WERE HOLES IN THE STAPLE LINE. THE SECOND DEVICE WAS FIRED AND THERE WAS A STAPLE LINE BLEEDING. THE SURGEON RESECTED AND RESTAPLED THE ANASTOMOSIS TO RESOLVE THE ISSUE.

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

  MAUDE report 24799084 ↗
• MalfunctionMar 30, 2026Failure to Form Staple

  IT WAS REPORTED THAT INTRAOPERATIVELY, WHEN SCOPING THE STAPLE LINE AFTER NORMAL FIRING AND CONFIRMING COMPLETE TISSUE DONUTS, ONE OF THE INNER MOST STAPLES WAS NOT FORMED PROPERLY. NO INTERVENTION WAS DONE.

  Patient problems: Failure to Anastomose

  MAUDE report 24737613 ↗
• MalfunctionMar 30, 2026Difficult to Remove

  IT WAS REPORTED THAT DURING A LOW ANTERIOR RESECTION, STAPLE WAS FIRED AND BECAME STUCK TO THE ANASTOMOSIS AND THE DEVICE WAS VERY DIFFICULT TO REMOVE FROM THE CAVITY. THE DEVICE WAS FREED BY SLIGHTLY TWISTING IT UNTIL IT RELEASED ITSELF. DONUTS AND AIR TESTS WERE PERFORMED AND RESULTS WERE GOOD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24722518 ↗
• MalfunctionMar 9, 2026Failure to Form Staple

  IT WAS REPORTED THAT DURING A ROBOTIC LOW ANTERIOR RESECTION (LAR) PROCEDURE, THE STAPLER WAS FIRED BY THE SURGEON, WHO DID NOT PERCEIVE ANY ISSUES DURING THE FIRING SEQUENCE. AFTER FIRING, A DIGITAL RECTAL EXAM REVEALED SHARP STAPLES PROTRUDING, AND ENDOSCOPIC EVALUATION SHOWED AN INCOMPLETE STAPLE LINE WITH A DEFECT AT THE 5¿6 O¿CLOCK POSITION, WHERE MALFORMED STAPLES WERE OBSERVED. THE ANASTOMOSIS APPEARED TO HAVE NOT HELD IN THIS AREA, RESULTING IN AN OPEN DEFECT. THE SURGEON ADDRESSED THE DEFECT BY SUTURING IT CLOSED, WHICH EXTENDED THE SURGICAL TIME FOR ABOUT 30 MINUTES.

  Patient problems: Failure to Anastomose

  MAUDE report 24547931 ↗
• MalfunctionDec 11, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A SIGMOID RESECTION, THE DEVICE WAS APPLIED AT THE ANASTOMOSIS OF COLON, THE ANVIL TIP FELL OFF THE STAPLER AFTER STAPLES WERE DISCHARGED. THE DEVICE WAS RETRIEVED WITH AN INSTRUMENT TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23783727 ↗
• InjuryNov 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A LOW ANTERIOR RESECTION, THE DEVICE WAS USED IN THE FINAL STEP TO RECONNECT THE DISTAL COLON TO THE PROXIMAL RECTUM. POSTOPERATIVELY, AN ANASTOMOTIC LEAK WAS IDENTIFIED AND ATTRIBUTED TO THE STAPLER. A LEAK TEST WAS PERFORMED DURING THE INITIAL SURGERY WITH NO BUBBLES OBSERVED, AND TWO COMPLETE DONUT SPECIMENS WERE OBTAINED. THE PATIENT REQUIRED READMITTANCE TO THE HOSPITAL, UNDERWENT AN ADDITIONAL SURGICAL PROCEDURE, AND A COLOSTOMY BAG WAS PLACED.

  Patient problems: Failure to Anastomose; Laceration(s)

  MAUDE report 23511633 ↗
• MalfunctionJul 28, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A ROBOTIC OSTOMY REVERSAL WITH ANASTOMOSIS OF THE COLON AND RECTUM, THE CIRCULAR STAPLER EXPERIENCED A SET-UP ISSUE PRIOR TO FIRING, WITH THE ANVIL DETACHING WHEN ATTEMPTING TO REMOVE IT FROM THE ANASTOMOSIS. THE DEVICE ONLY ALLOWED THE BLACK TWIST KNOB TO BE TURNED TWO FULL ROTATIONS BEFORE AN AUDIBLE CLICK WAS HEARD. THE DEVICE WAS REPLACED WITH A COMPETITOR'S PRODUCT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22628217 ↗
• MalfunctionApr 21, 2025Material Twisted/Bent; Incomplete or Inadequate Connection; Material Twisted/Bent; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT DURING THE PROCEDURE, BEFORE CATCHING THE ANVIL, THE TIP WAS BENT AND COULD NOT BE CONNECTED TO EACH OTHER. THE SURGERY WAS COMPLETED WITH A NEW PRODUCT 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 21874786 ↗
• MalfunctionMar 13, 2025Failure to Align; Incomplete or Inadequate Connection; Failure to Align; Incomplete or Inadequate Connection

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, DURING SETUP PRIOR TO FIRING, THE ANVIL TILTED. THE ANVIL WOULD NOT ATTACH TO THE BODY OF THE STAPLER. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21590918 ↗
• MalfunctionJan 29, 2025Difficult to Remove; Difficult to Open or Close; Difficult to Remove; Difficult to Open or Close

  ACCORDING TO THE REPORTER, PRIOR TO USE OF THE DEVICE, THE JAW FAILED TO OPEN DURING TESTING.

  Patient problems: Insufficient Information

  MAUDE report 21267102 ↗
• InjuryJan 16, 2025Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING A ROBOTIC LAPAROSCOPIC HEMICOLECTOMY PROCEDURE, IN THE THE SIGMOID ANASTOMOSIS, THE FIRST STAPLER FIRED CORRECTLY, BUT NO STAPLES WERE VISUALLY CONFIRMED AS DEPLOYED. THE DEVICE CUT BUT DID NOT STAPLE. THE TISSUE WAS PREPPED AND ANOTHER STAPLER WAS USED, RESULTING IN APPROXIMATELY 50% STAPLE DEPLOYMENT, LEAVING HALF OF THE ANASTOMOSIS WIDE OPEN. THE SURGEON THEN REDID THE ANASTOMOSIS WITH A THIRD STAPLE FIRING SINCE IT WAS TOO LARGE TO OVERSEW, WHICH RESULTED IN TWO PROPERLY FORMED "DONUTS." A LEAK TEST WAS PERFORMED, REVEALING NO LEAKS. IT WAS NOTED THAT THE PROCEDURE WAS CONVERTED TO OPEN SURGERY DUE TO CHALLENGING ANATOMY, EXTENDING THE SURGICAL TIME BY ONE HOUR.

  Patient problems: Failure to Anastomose; Laceration(s)

  MAUDE report 21173538 ↗
• InjuryJan 16, 2025Mechanics Altered; Mechanics Altered

  IT WAS REPORTED THAT DURING A ROBOTIC LAPAROSCOPIC HEMICOLECTOMY PROCEDURE, IN THE THE SIGMOID ANASTOMOSIS, THE FIRST STAPLER FIRED CORRECTLY, BUT NO STAPLES WERE VISUALLY CONFIRMED AS DEPLOYED. THE DEVICE CUT BUT DID NOT STAPLE. THE TISSUE WAS PREPPED AND ANOTHER STAPLER WAS USED, RESULTING IN APPROXIMATELY 50% STAPLE DEPLOYMENT, LEAVING HALF OF THE ANASTOMOSIS WIDE OPEN. THE SURGEON THEN REDID THE ANASTOMOSIS WITH A THIRD STAPLE FIRING SINCE IT WAS TOO LARGE TO OVERSEW, WHICH RESULTED IN TWO PROPERLY FORMED "DONUTS." A LEAK TEST WAS PERFORMED, REVEALING NO LEAKS. IT WAS NOTED THAT THE PROCEDURE WAS CONVERTED TO OPEN SURGERY DUE TO CHALLENGING ANATOMY, EXTENDING THE SURGICAL TIME BY ONE HOUR.

  Patient problems: Failure to Anastomose; Laceration(s)

  MAUDE report 21173516 ↗
• MalfunctionAug 21, 2024Failure to Align; Failure to Align

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE ANVIL WAS FOLDED PRIOR TO FIRING. A NEW STAPLER WAS USED TO COMPLETE THE SURGERY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20011479 ↗
• MalfunctionAug 13, 2024Adverse Event Without Identified Device or Use Problem; Noise, Audible; Adverse Event Without Identified Device or Use Problem; Noise, Audible

  ACCORDING TO THE REPORTER, DURING A ROBOTIC LAPAROSCOPIC SIGMOIDECTOMY PROCEDURE, THERE WAS NO AUDIBLE CLICK DURING THE FIRING OF THE INSTRUMENT. THERE WAS A SMALL AIR LEAK DURING THE AIR TESTING OF THE ANASTOMOSIS. THE SURGEON REPAIRED IT WITH SUTURES AND RE-TESTED WITH AIR, AND THERE WERE NO LEAKS DURING THE RE-TEST.

  Patient problems: Failure to Anastomose

  MAUDE report 19977985 ↗
• InjuryJun 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING AN EXPLORATORY LAPAROTOMY COLON RESECTION, IN COLON RESECTION WHEN CREATING THE ANASTOMOSIS WITH THE CIRCULAR STAPLER, THE SURGEON WAS UNSURE IF THE DEVICE HAD INITIALLY FIRED. HOWEVER, THE STAPLER AND ANVIL REMAINED ATTACHED TO THE COLON/RECTUM AND WOULD NOT RELEASE. THE SURGEON ATTEMPTED TO OPEN THE STAPLER TO REMOVE IT, BUT IT REMAINED STUCK. TO RESOLVE THE ISSUE, THE SURGEON CLOSED THE STAPLER AND FIRED IT AGAIN TO RELEASE THE TISSUE. A SECOND STAPLER WAS UTILIZED TO CREATE A SUCCESSFUL ANASTOMOSIS THAT WAS LEAK TESTED SUCCESSFULLY. THE PATIENT WAS RECOVERING WELL WITHIN 48 HOURS OF THE PROCEDURE. ON THE EIGHT-DAY POST-OPERATION, THE PATIENT WAS TREATED FOR INCISION RUPTURE AND PAIN. SUBSEQUENT EVALUATION CONCLUDED A PROBABLE ANASTOMOTIC LEAK. DURING AN OPEN EXPLORATORY LAPAROTOMY, IT WAS DISCOVERED THE ANASTOMOSIS CREATED HAD FAILED. THE PATIENT HAD TISSUE DAMAGE AS MORE COLON HAD TO BE REMOVED, THE SIGMOID COLON WAS REMOVED. A COLOSTOMY WAS PERFORMED, AND A TEMPORARY COLOSTOMY BAG WAS REQUIRED TO ESTABLISH BOWEL FUNCTION. THE PATIENT HOSPITALIZATION WAS EXTENDED AS WELL.

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

  MAUDE report 19516106 ↗
• MalfunctionJun 1, 2024Difficult to Remove; Difficult to Remove

  ACCORDING TO THE REPORTER, DURING AN EXPLORATORY LAPAROTOMY COLON RESECTION, IN COLON RESECTION WHEN CREATING THE ANASTOMOSIS WITH THE CIRCULAR STAPLER, THE SURGEON WAS UNSURE IF THE DEVICE HAD INITIALLY FIRED. HOWEVER, THE STAPLER AND ANVIL REMAINED ATTACHED TO THE COLON/RECTUM AND WOULD NOT RELEASE. THE SURGEON ATTEMPTED TO OPEN THE STAPLER TO REMOVE IT, BUT IT REMAINED STUCK. TO RESOLVE THE ISSUE, THE SURGEON CLOSED THE STAPLER AND FIRED IT AGAIN TO RELEASE THE TISSUE. A SECOND STAPLER WAS UTILIZED TO CREATE A SUCCESSFUL ANASTOMOSIS THAT WAS LEAK TESTED SUCCESSFULLY. THE PATIENT WAS RECOVERING WELL WITHIN 48 HOURS OF THE PROCEDURE. ON THE EIGHT-DAY POST-OPERATION, THE PATIENT WAS TREATED FOR INCISION RUPTURE AND PAIN. SUBSEQUENT EVALUATION CONCLUDED A PROBABLE ANASTOMOTIC LEAK. DURING AN OPEN EXPLORATORY LAPAROTOMY, IT WAS DISCOVERED THE ANASTOMOSIS CREATED HAD FAILED. THE PATIENT HAD TISSUE DAMAGE AS MORE COLON HAD TO BE REMOVED, THE SIGMOID COLON WAS REMOVED. A COLOSTOMY WAS PERFORMED, AND A TEMPORARY COLOSTOMY BAG WAS REQUIRED TO ESTABLISH BOWEL FUNCTION. THE PATIENT'S HOSPITALIZATION WAS EXTENDED AS WELL.

  Patient problems: Insufficient Information

  MAUDE report 19442014 ↗
• InjuryFeb 21, 2024Difficult to Remove; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Difficult to Remove; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SIGMOID COLECTOMY, THE STAPLER WAS INSERTED WHEN GOING TO CREATE ANASTOMOSIS IN THE BUTT OF PATIENT, BUT THE ANVIL FELL AND WAS STUCK INSIDE THE COLON OF THE PATIENT AND THE SURGEON HAD TO USE AN INSTRUMENT TO REMOVE THE ANVIL SEPARATELY. THE PATIENT HAD TO COME BACK TO THE EMERGENCY ROOM DUE TO PAIN THE PATIENT WAS EXPERIENCING. ONCE THE SURGEON DID THE TEST, THE PATIENT HAD A LEAK AND HAD TO GO BACK INTO SURGERY TO FIX IT AND THE PATIENT HAD TO GET A TEMPORARY COLOSTOMY BAG. THE SURGEON FINISHED THE CASE DUE TO IT PASSED THE LEAK TEST WHICH HELPED KNOW THAT THE STAPLE LINE WAS COMPLETE. IT WAS NOTED THAT AS PER SURGEON, DUE TO THE PRESSURE EXPERIENCED WHEN TRYING TO REMOVE THE STAPLER OUT OF THE PATIENT, THE ANVIL EITHER GOT STUCK ON THE STAPLE LINE OR STUCK ON THE COLON WALL AND POSSIBLY CAUSED THE LEAK/HOLE IN THE COLON AFTER THE PATIENT WAS DISCHARGED. ONCE THE PATIENT HEALED, A NEW ANASTOMOSIS WILL BE DONE.

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

  MAUDE report 18754314 ↗
• InjuryOct 20, 2023Failure 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 AN OPEN COLON RESECTION, DURING THE ANASTOMOSIS, THE TECHNICIAN FIRED THE DEVICE AND THE STAPLE LINE WAS COMPLETE. AS PER THE SURGEON, THE DONUTS WERE INTACT, BUT IT FAILED BASED ON THE PATIENT'S TISSUE BEING SO FRIABLE. MOREOVER, THE STAPLE LINE DID NOT HOLD, AND THERE WAS POOR STAPLE FORMATION. HENCE, THE TISSUE CAME APART. IT WAS NOTED THAT SIZERS WERE USED. MORE TISSUE WAS REMOVED FROM THE TISSUE, AND A COMPETITOR'S CIRCULAR STAPLER WAS FIRED LOW IN THE ABDOMEN NEAR THE RECTUM, AND IT ALSO FAILED TO HOLD THE TISSUE TOGETHER. IT WAS NOTED THAT THE PATIENT HAD TO HAVE A PERMANENT COLOSTOMY DUE TO THE TISSUE ISSUE.

  Patient problems: Failure to Anastomose; Tissue Breakdown

  MAUDE report 17980257 ↗
• InjuryApr 18, 2023Misfire; Failure to Form Staple; Detachment of Device or Device Component; Human-Device Interface Problem; Adverse Event Without Identified Device or Use Problem; Misfire; Failure to Form Staple; Detachment of Device or Device Component; Human-Device Interface Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC LOWER ANTERIOR RESECTION, WHEN END TO END ANASTOMOSIS PERFORMED, THE SURGEON FORCED THE SAFETY AWAY FROM THE STAPLER. IT WAS UNKNOWN IF THE SURGEON SAW GREEN IN THE INDICATOR WINDOW. THE SAFETY WOULD NOT RELEASE SO THE SURGEON FORCED THE SAFETY AWAY AND FIRED THE CIRCULAR STAPLER WHICH CAUSED THE MISFIRE. AS A RESULT, THERE WAS A POOR STAPLE FORMATION, INCOMPLETE STAPLE LINE, THE DONUT WAS POORLY FORMED, STAPLES FELL INTO THE CAVITY OF THE PATIENT AND THE ANASTOMOTIC SITE WAS TORN. THE PROCEDURE WAS CONVERTED TO OPEN, THE SURGEON HAD TO RE-TRANSECT THE COLON AND DIVERT THE PATIENT TO AN ILEOSTOMY. THE SURGICAL TIME WAS EXTENDED 30 MINUTES OR MORE, AND EXTENDED THE PATIENT HOSPITALIZATION (2 DAYS) DUE TO THE DEVICE PROBLEM.

  Patient problems: Failure to Anastomose; Foreign Body In Patient; Unspecified Tissue Injury

  MAUDE report 16761987 ↗
• MalfunctionMar 1, 2023Detachment of Device or Device Component; Human-Device Interface Problem; Adverse Event Without Identified Device or Use Problem; Detachment of Device or Device Component; Human-Device Interface Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC LEFT COLON RESECTION, WHILE ON END TO END ANASTOMOSIS, THE SURGEON TRIED TO REMOVE THE STAPLER AFTER FIRING BUT WAS MET WITH RESISTANCE. THE SURGEON CAME DOWN BELOW AND REMOVED THE STAPLER WITH FORCE AND NOTICED THE ANVIL HAD COME OFF AND WAS STILL IN THE PATIENT. THE TILT TOP ANVIL WAS LOCKED IN THE TILTED POSITION AFTER THE END TO END ANASTOMOSIS WAS REMOVED FROM THE PATIENT. THE SURGICAL TIME WAS EXTENDED FOR 30 MINUTES OR MORE AS A RESULT. TO RESOLVE THE ISSUE, THE SURGEON RETRIEVED THE TILT TOP ANVIL, AND TWO LEAK TESTS WERE DONE TO TEST THE INTEGRITY OF THE ANASTOMOSIS AND BOTH SHOWED NO LEAK. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16460622 ↗
• InjuryJan 5, 2023Failure 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 LAPAROSCOPIC COLON RESECTION, IN THE COLON, THE DEVICE PARTIALLY FIRED. ADDITIONALLY, THE STAPLES DID NOT MAKE FULL B SHAPE. THIS RESULTED IN TISSUE DAMAGE AND UNANTICIPATED TISSUE LOSS AS THE SURGEON NEED TO REDO THE ANASTOMOSIS BY RE-STAPLING THE DISTAL END OF THE ANASTOMOSIS WITH ANOTHER CIRCULAR STAPLER. THE PROCEDURE WAS EXTENDED FOR MORE THAN THIRTY MINUTES.

  Patient problems: Failure to Anastomose; Unspecified Tissue Injury

  MAUDE report 16104763 ↗
• InjurySep 30, 2022No Device Output; Device Slipped; Failure to Form Staple; Adverse Event Without Identified Device or Use Problem; Noise, Audible; No Device Output; Device Slipped; Failure to Form Staple; Adverse Event Without Identified Device or Use Problem; Noise, Audible

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC COLON RESECTION/ILEOSTOMY TAKEDOWN, THE SURGEON WAS ABLE TO PRESS THE SAFETY BUTTON. THE ANVIL AND TROCAR SPIKE WAS NOT FULLY APPROXIMATED, THE SURGEON DID NOT FEEL OR HEAR THE TACTILE CRUNCH WHEN THE HANDLE WAS PUL LED. THE KNIFE BLADE WAS DEPLOYED, BUT THE STAPLES DID NOT FORM. WHEN THE STAPLER WAS REMOVED, IT WAS OBSERVED THAT THE DISTAL AND PROXIMAL PORTIONS OF COLON WAS CUT. THE SURGEON ATTEMPTED TO REPAIR LAPAROSCOPICALLY, BUT WAS FORCED TO GO OPEN TO CREATE ANASTOMOSIS. THE INCISION WAS EXTENDED MORE THAN 1 INCH.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 15522028 ↗
• InjuryJun 28, 2022Difficult to Remove; Failure to Form Staple; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Difficult to Remove; Failure to Form Staple; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  ACCORDING TO THE REPORTER, DURING OPEN COLON PROCEDURE, THE DEVICE HAD POOR STAPLE FORMATION WHEN IT WAS BEING APPLIED TO ANUS AND COLON. THERE WAS EXCESSIVE TISSUE INCORPORATED INTO THE BARREL OF THE STAPLER. THE STAPLE LINE WAS LEAKING, INCOMPLETE. IT WAS DIFFICULT TO REMOVE THE STAPLER FROM THE CAVITY. IN ORDER TO HAVE IT REMOVED, IT WAS WIGGLED AND PULLED STRAIGHT OUT. THE ANVIL TILTED AFTER FIRING. THE SURGEON HAD TO HAND SEW OVER THE STAPLE LINE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 14847031 ↗
• MalfunctionMay 5, 2022Loss of or Failure to Bond; Material Twisted/Bent; Loss of or Failure to Bond; Material Twisted/Bent

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC LOW ANTERIOR RESECTION, WHEN CREATING ANASTOMOSIS, THE LEGS ON THE ANVIL WERE PULLED APART (BENT), NOT ALLOWING DEVICE TO CONNECT TO THE STAPLER SPIKE. A NEW STAPLER WAS OPENED AND CHANGED OUT THE ANVIL. A NEW PURSE STRING WAS CREATED AND SURGICAL TIME GOT EXTENDED BY AT LEAST 30 MINUTES. THERE WAS NO PATIENT INJURY.

  Patient problems: Epilepsy; No Clinical Signs, Symptoms or Conditions

  MAUDE report 14289434 ↗
• MalfunctionAug 24, 2021Difficult to Insert; Difficult to Insert

  ACCORDING TO THE REPORTER, DURING ROBOTIC LOW ANTERIOR RESECTION, THE SURGEON HAD DIFFICULTY INSERTING THE STAPLER INTO THE RECTUM COMPARED TO USING OTHER MANUFACTURER'S DEVICE. THE CASE WAS COMPLETED USING THE SAME STAPLER. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12362714 ↗