EEA TRIEEA25MTRecalls & reported problems

Summary

The FDA's MAUDE database contains 46 adverse event reports that list this exact device (DI 10884521593008), received between Mar 28, 2023 and Aug 18, 2026 — classified as 6 injuries, 40 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (12 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 46 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 18, 2026Difficult to Remove

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50304101 ↗
• MalfunctionJul 28, 2026Failure to Form Staple

  Patient problems: Failure to Anastomose

  MAUDE report 50059045 ↗
• MalfunctionApr 22, 2026

  DURING A SURGICAL PROCEDURE TO REVERSE A COLOSTOMY, TWO CIRCULAR STAPLERS DID NOT FUNCTION PROPERLY. THE ANVIL PORTION APPEARED TO BE BENT SO THE EQUIPMENT COULD NOT ENGAGE AND STAPLE PROPERLY. THE SURGEONS MADE SEVERAL ATTEMPTS TO FIT THE PIECES TOGETHER AS DESIGNED HOWEVER THEY DETERMINED THAT THE BENT METAL PIECE WAS NOT FIXABLE AND THEY EVENTUALLY GOT A DIFFERENT SIZE WHICH WORKED APPROPRIATELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24953127 ↗
• MalfunctionMar 31, 2026Difficult to Remove; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING AN ILEOSTOMY REVERSAL SURGERY, A CIRCULAR STAPLER WAS USED FOR SMALL INTESTINE-TO-SMALL INTESTINE ANASTOMOSIS, AND IT WAS FOUND THAT THE STAPLING WAS POORLY FORMED, SO SUTURES WERE SUBSEQUENTLY USED TO OVERSEW THE STAPLE LINE TO REINFORCE IT. IT WAS ALSO REPORTED THAT THE ANVIL COULD NOT BE TILTED AFTER FIRING.

  Patient problems: Failure to Anastomose

  MAUDE report 24745037 ↗
• MalfunctionMar 10, 2026Difficult to Remove; Failure to Form Staple

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC RIGHT HEMICOLECTOMY WITH SIDE-TO-SIDE ANASTOMOSIS OF THE RIGHT COLON TO THE TRANSVERSE COLON, THE CIRCULAR STAPLER WAS USED AND B-SHAPED STAPLE MALFORMATION WAS OBSERVED. EXCESSIVE TISSUE WAS INCORPORATED INTO THE BARREL OF THE STAPLER. THE INSTRUMENT HANDLE WAS FULLY SQUEEZED, AND THE DONUTS WERE COMPLETE. IT WAS ALSO NOTED THAT THE ANVIL DID NOT TILT AFTER FIRING. THE STAPLE LINE ISSUE WAS RESOLVED BY OVERSEWING.

  Patient problems: Failure to Anastomose

  MAUDE report 24564002 ↗
• MalfunctionFeb 12, 2026Failure to Align; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC DISTAL GASTRECTOMY, WHEN ON RESIDUAL GASTRIC ANASTOMOSIS AND DIGESTIVE TRACT RECONSTRUCTION, THERE WAS POOR STAPLE FORMATION AND BLOOD OOZING. IT WAS ALSO NOTED THAT THE ANVIL DID NOT TILT AFTER FIRING. A NEW CIRCULAR STAPLER WAS USED TO RESOLVE THE ISSUE.

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

  MAUDE report 24327876 ↗
• MalfunctionJan 29, 2026Incomplete or Inadequate Connection

  IT WAS REPORTED THAT, DURING A PROCEDURE, PRIOR TO FIRING, THE ANVIL OF THE CIRCULAR STAPLER WAS DIFFICULT TO ATTACH. THE DEVICE WAS REPLACED WITH ANOTHER OF THE SAME TYPE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24208020 ↗
• MalfunctionJan 16, 2026Incomplete or Inadequate Connection

  IT WAS REPORTED THAT, DURING THE PROCEDURE, WHEN ON SETTING UP PRIOR TO FIRING, THE ANVIL OF THE CIRCULAR STAPLER WAS DIFFICULT TO ATTACHED. THE DEVICE WAS REPLACED WITH ANOTHER OF THE SAME TYPE FROM THE SAME MANUFACTURER. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24101838 ↗
• MalfunctionDec 30, 2025Material Twisted/Bent; Incomplete or Inadequate Connection; Material Twisted/Bent; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT DURING A RECTAL RESECTION, WHILE ON RECTAL ANASTOMOSIS, THE ATTACHMENT OF THE ANVIL WAS DIFFICULT AND THE SHAFT OF THE ANVIL WAS BENT. A NEW PRODUCT OF THE SAME PRODUCT NUMBER WAS TAKEN OUT AND USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23930115 ↗
• MalfunctionDec 23, 2025Detachment of Device or Device Component; Human-Device Interface Problem; Detachment of Device or Device Component; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, DURING A RECTAL RESECTION PROCEDURE WITH ROBOT SUPPORT, AN ISSUE OCCURRED WHEN THE ANVIL OF THE DEVICE BECAME LOOSE AND DETACHED FROM THE CENTER SHAFT AFTER DOCKING. DESPITE THE ROTATING KNOB BEING SECURELY FIXATED, THE ANVIL SIDE INSERTION PORT REMAINED OPEN, CAUSING THE DEVICE TO BECOME UNSTABLE AND COME OFF DURING USE. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23882667 ↗
• MalfunctionDec 17, 2025Difficult to Remove; Difficult to Remove

  ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC RECTAL RESECTION, WHEN PERFORMING DOUBLE-STAPLING TECHNIQUE ANASTOMOSIS, THE TISSUE GOT STUCK BUT THE DEVICE WAS ABLE TO BE REMOVED. HAND SEWN WITH ADDITIONAL SUTURES WAS PERFORMED TO RESOLVE THE ISSUE. THE SURGICAL TIME WAS EXTENDED FOR 15 MINUTES AS A RESULT.

  Patient problems: Tissue Breakdown

  MAUDE report 23834935 ↗
• MalfunctionDec 16, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING HIGH ANTERIOR RESECTION AFTER PERFORMING A RECTAL ANASTOMOSIS ABOUT 15 CM FROM THE ANUS, WHEN THE DEVICE WAS REMOVED, THE ANVIL WAS DETACHED FROM THE CENTER SHAFT OF THE STAPLER AND WAS LEFT INSIDE THE RECTUM. A SMALL ABDOMINAL INCISION HAD BEEN MADE, SO THE SURGEON INSERTED A HAND FROM THERE, AND SENT THE ANVIL TO THE ANUS, AND INSERTED HAND FROM THE ANUS, AND IT WAS REMOVED.

  Patient problems: Laceration(s); Tissue Breakdown

  MAUDE report 23813248 ↗
• MalfunctionDec 8, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A PROCEDURE, THE INSTRUMENT DID NOT FIRE. THE DEVICE WAS REPLACED WITH A NEW CIRCULAR STAPLER. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23752329 ↗
• MalfunctionOct 28, 2025Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING RECTAL RECONSTRUCTION AFTER HARTMANN, AFTER HEARING A CLICKING SOUND TWICE, REMOVAL WAS ATTEMPTED AS IS, BUT THE ANVIL SEEMED TO BE CAUGHT AND DID NOT COME OUT, WHEN TURNING THE KNOB A BIT MORE, AND PULLED WITH ALL STRENGTH, THE ANVIL REMAINED, AND ONLY THE STAPLER CAME OUT. IT APPEARED TO HAVE BEEN PUNCHED OUT, AND THE ANVIL WAS ABLE TO BE RETRIEVED. IN ADDITION, THERE WAS DAMAGE WITH A HOLE ABOUT ONE FINGER ON THE SIDE OF THE ANASTOMOSIS SO MANUAL SUTURING WAS PERFORMED TO REINFORCE THE STAPLE LINE, WHICH RESULTED TO A 30-MINUTE EXTENDED SURGICAL TIME.

  Patient problems: Failure to Anastomose; Tissue Breakdown

  MAUDE report 23403922 ↗
• InjuryOct 22, 2025Break; Difficult to Remove; Detachment of Device or Device Component; Break; Difficult to Remove; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC SIGMOID COLON AND BLADDER RESECTION FOR BLADDER PERFORATION DUE TO SIGMOID DIVERTICULITIS, DURING SIDE-TO-END ANASTOMOSIS OF THE COLON AND RECTUM, AFTER FIRING THE STAPLER, THE ROTATION KNOB WAS TURNED ONCE. AFTER CONFIRMING THAT A CLICKING SOUND WAS HEARD, AN ATTEMPT WAS MADE TO REMOVE THE STAPLER, BUT IT COULD NOT BE REMOVED. THE STAPLER WAS PUSHED TOWARD THE HEAD SIDE AND PULLED TOWARD THE ANAL SIDE, BUT IT COULD NOT BE REMOVED. CONSIDERING THE POSSIBILITY OF INSUFFICIENT ROTATION OF THE ROTATION KNOB, THE ROTATION KNOB WAS ROTATED SEVERAL TIMES AGAIN AND REMOVAL WAS REATTEMPTED, BUT IT COULD NOT BE REMOVED FOR A WHILE. AFTER SEVERAL ATTEMPTS AT REMOVAL, THE STAPLER WAS REMOVED, BUT IT WAS REMOVED WITH THE ANVIL REMAINING INSIDE THE BODY. UPON INSPECTION OF THE INTESTINAL TRACT USING A COLONOSCOPE, THE ANVIL REMAINED, STILL ATTACHED IN A CIRCULAR PATTERN WHERE THE FIRING HAD BEEN PERFORMED. WHEN THE ANVIL WAS SLOWLY PUSHED TOWARD THE HEAD SIDE USING A COLONOSCOPE, THE ANVIL DETACHED FROM THE STAPLE LINE, AND IT COULD BE CONFIRMED THAT THE FIRING WAS COMPLETED. A FORCEPS WAS INSERTED FROM THE ANAL SIDE, AND THE ANVIL WAS REMOVED

  Patient problems: Failure to Anastomose

  MAUDE report 23363546 ↗
• MalfunctionSep 5, 2025Difficult to Remove; Difficult to Remove

  ACCORDING TO THE REPORTER, DURING RECTAL RESECTION AFTER THE ANASTOMOSIS, THE ANVIL DID NOT TILT AFTER FIRING. SINCE THE ISSUE OCCUR RED WHEN THE PRODUCT WAS REMOVED FROM THE BODY AFTER USE, THE PROCEDURE WAS COMPLETED WITHOUT ANY ADDITIONAL ACTION. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22986367 ↗
• MalfunctionAug 19, 2025Difficult to Insert; Difficult to Insert

  ACCORDING TO THE REPORTER, DURING RADICAL GASTRECTOMY WHILE ON COLOGASTRIC ANASTOMOSIS, IT WAS NOTED THAT THE INSTRUMENT HAD INABILITY TO ENTER THE INTESTINAL END. REPLACING OF NEW INSTRUMENTS WAS DONE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22840054 ↗
• MalfunctionJul 30, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING A ROBOT ASSISTED HIGH ANTERIOR RESECTION, PRIOR TO USE, WHEN THE DEVICE WAS TAKEN OUT FROM THE PACKAGING, THE PART OF THE ANVIL WAS DAMAGED. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22666567 ↗
• MalfunctionJul 23, 2025Misfire; Misfire

  IT WAS REPORTED THAT THE ANASTOMOSIS WAS NOT WORKING WELL DURING USE OF THE CIRCULAR STAPLER. THE DEVICE WAS REPLACED.

  Patient problems: Failure to Anastomose

  MAUDE report 22582379 ↗
• MalfunctionJul 17, 2025Material Twisted/Bent; Incomplete or Inadequate Connection; Material Twisted/Bent; Incomplete or Inadequate Connection

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC RECTAL RESECTION, THE ANVIL SHAFT WAS DEFORMED AND DOCKING WAS NOT POSSIBLE BETWEEN THE ORAL ANVIL SHAFT AND THE CIRCULAR STAPLER. IT WAS NOTED THAT THE ORAL INTESTINE WAS BROUGHT OUT OF THE BODY, THE ORAL SUTURE THREAD WAS CUT, AND ONLY THE ANVIL HEAD OF THE NEW PRODUCT WAS INSERTED INTO THE ORAL INTESTINE THAT HAD BEEN RESEWN. THEN, ANASTOMOSIS WAS PERFORMED. THE OPERATION TIME WAS EXTENDED BY ABOUT 20 MINUTES.

  Patient problems: Failure to Anastomose; Tissue Breakdown

  MAUDE report 22532839 ↗
• InjuryJun 30, 2025Failure to Form Staple; Failure to Cut; Human-Device Interface Problem; Noise, Audible; Firing Problem; Failure to Form Staple; Failure to Cut; Human-Device Interface Problem; Noise, Audible; Firing Problem

  ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC SIGMOID COLECTOMY, WHEN ON COLONIC ANASTOMOSIS, THE GREEN MARK WAS CONFIRM AND THE LOCK WAS RELEASE BUT FELT LIKE THERE WAS SLIGHT RESISTANCE. DURING THE FIRING, THERE WAS A HARD FEEL AND SOUND THAT DIFFERENT FROM USUAL. IT WAS NOTED THAT ONLY PARTIAL FIRING WAS PERFORMED. AT THE ANASTOMOTIC SITE, ONLY A PORTION OF THE ANAL-SIDE COLON/DISTAL COLON WAS RESECTED, AND THE ORAL-SIDE COLON/PROXIMAL COLON WAS NOT RESECTED AT ALL. THE STAPLE WAS FIRED, BUT MOST OF THEM REMAINED IN A U-SHAPE, DID NOT FORM B-SHAPE AND PIERCED THE TISSUE. FROM THE SMALL ABDOMINAL INCISION, THE ANVIL WAS MANUALLY REMOVED FROM THE STAPLER, AND THE ANAL-SIDE COLON/DISTAL COLON WITH A HOLE WAS CLOSED WITH SUTURES. IT WAS REPLACED WITH A NEW CIRCULAR STAPLER, ADDITIONAL RESECTION WAS PERFORMED TO THE ORAL-SIDE COLON/PROXIMAL COLON, AND THE ANVIL WAS RE-INSERTED. RE-ANASTOMOTIC WAS PERFORMED IN THE ANAL-SIDE COLON/DISTAL COLON OF THE UNDAMAGED SIDE. A COVERING STOMA WAS PLACED, AND THE PROGRESS WAS BEING OBSERVED. THE SURG ICAL TIME WAS EXTENDED FOR 120 MINUTES AS A RESULT.

  Patient problems: Failure to Anastomose; Laceration(s)

  MAUDE report 22367248 ↗
• MalfunctionJun 17, 2025Misfire; Misfire

  ACCORDING TO THE REPORTER, DURING A ROBOTIC LOW ANTERIOR RESECTION, DURING COLORECTAL ANASTOMOSIS, AFTER FIRING, THE DONUT RING WAS CHECKED, AND IT WAS FOUND TO BE CHIPPED AND INCOMPLETE, AND AN ADDITIONAL SUTURE WAS PERFORMED. AT THAT TIME, THE STAPLE WAS NOT FOUND. SURGICAL TIME WAS EXTENDED BY AN HOUR.

  Patient problems: Failure to Anastomose

  MAUDE report 22230774 ↗
• MalfunctionMay 16, 2025Difficult to Remove; Difficult to Remove

  ACCORDING TO THE REPORTER DURING A LAPAROSCOPIC COLECTOMY THE CIRCULAR STAPLER ENCOUNTERED DIFFICULTY DURING REMOVAL AFTER FIRING, AS THE PLATE PASSED THROUGH THE ANASTOMOTIC REGION AND THE ANVIL TILTED, CAUSING THE STAPLER TO BE DIFFICULT TO EXTRACT. THE DEVICE WAS REMOVED BY MOVING AND ROTATING IT AND THE PROCEDURE WAS COMPLETED WITH ADDITIONAL RESECTION AND STAPLER SUTURING, WHICH EXTENDED THE SURGERY BY ONE HOUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22037258 ↗
• MalfunctionMay 15, 2025Difficult to Remove; Human-Device Interface Problem; Difficult to Remove; Human-Device Interface Problem

  IT WAS REPORTED THAT THERE WERE SET-UP ISSUES PRIOR TO FIRING WITH THE HEMORRHOID STAPLER FOR A ROUX-EN-Y BYPASS. THE HEAD OF THE INSTRUMENT DID NOT COME OFF, SO THEY WERE UNABLE TO USE THE PRODUCT, AND NO STAPLES WERE ACTUALLY FIRED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22023991 ↗
• InjuryMay 9, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DIRECT INTESTINAL RESECTION, THE FRAGMENT WAS NOT DROPPED BUT THE TRANSPARENT PLASTIC ON THE ANVIL TRAY WAS DETACHED AFTER ANASTOMOSIS. IT WAS NOTED THAT AN X-RAY WAS USED TO CHECK FOR ANY RESIDUALS IN THE BODY. A TREATMENT OR INTERVENTION WAS NOT NECESSARY.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 21996197 ↗