EEA EEA31Recalls & reported problems

Summary

The FDA's MAUDE database contains 543 adverse event reports that list this exact device (DI 10884523005554), received between Jul 19, 2016 and Sep 30, 2026 — classified as 4 deaths, 252 injuries, 287 malfunctions.

The most frequently reported specific device problem is “Failure to Form Staple” (142 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 543 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Failure to Align

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50950953 ↗
• InjuryAug 18, 2026Mechanics Altered

  It was reported that during a sigmoid colectomy, during an end-to-end anastomosis in the rectum, the anvil and stapler were inserted, successfully mated, and closed until the green bar was visible, after which the red safety bar was removed and the instrument was fired. The surgeon had trouble squeezing and felt the stapler was not firing. The safety bar was replaced and the stapler was removed, and it was observed that the device cut but staples did not deploy, leaving a 31 mm hole in the rectum. The surgical time was extended by 75 minutes, more colon was resected than originally planned, and the procedure was converted to a low anterior resection. Another 31 mm circular stapler was then used to create the anastomosis, and the reported action to address the issue was to resect and re-staple.

  Patient problems: Failure to Anastomose; Tissue Breakdown

  MAUDE report 50300675 ↗
• InjuryJul 1, 2026Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THE PATIENT UNDERWENT A LEFT HEMICOLECTOMY FOR SIGMOID NEOFORMATION ON (B)(6) 2026. THE PROCEDURE INCLUDED RECTAL TRANSECTION WITH A SINGLE FIRING OF A 60 MM PURPLE RELOAD AND A COLORECTAL ANASTOMOSIS PERFORMED ACCORDING TO THE KNIGHT-GRIFFEN TECHNIQUE USING A 31 MM CIRCULAR STAPLER. A PNEUMATIC LEAK TEST WAS NEGATIVE, AND 90 SECONDS OF PRECOMPRESSION WERE PERFORMED. ON (B)(6) 2026, THE PATIENT UNDERWENT REINTERVENTION FOR AN EARLY ANASTOMOTIC FISTULA. INTRAOPERATIVE FINDINGS SHOWED PARTIAL DEHISCENCE OF THE ANTERIOR WALL, WITH STAPLES APPEARING PARTIALLY OPEN, SUGGESTIVE OF INCOMPLETE OR INCORRECT CLOSURE.

  Patient problems: Failure to Anastomose; Fistula; Organ Dehiscence; Tissue Breakdown

  MAUDE report 25680294 ↗
• MalfunctionMay 1, 2026Difficult to Insert; Device Slipped; Difficult to Open or Close

  IT WAS REPORTED THAT, DURING A PROCEDURE, PRIOR TO FIRING THE DEVICE FOR ANASTOMOSIS, THE DEVICE WAS DIFFICULT TO INSERT INTO THE PATIENT. AN UNUSUAL EFFORT WAS REQUIRED TO TURN THE WINGNUT OR TWIST KNOB TO VISUALIZE THE GREEN BAR, THE USER WAS ALSO UNABLE TO TWIST THE KNOB TO OPEN THE TROCAR. THE DEVICE WAS REPLACED WITH A DIFFERENT TYPE OF CIRCULAR STAPLER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25059529 ↗
• MalfunctionApr 30, 2026Break

  IT WAS REPORTED THAT DURING A PROCEDURE, THE SHAFT BROKE. THE BROKEN PART DID NOT DISENGAGE. THE STAPLER WAS TAKEN OUT AND REPLACED WITH A NEW ONE TO CONTINUE USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25050387 ↗
• MalfunctionMar 19, 2026Misfire; Noise, Audible

  ACCORDING TO THE REPORTER, DURING A RECTOSIGMOIDECTOMY, THE CIRCULAR STAPLER MADE AN UNUSUAL NOISE AND DID NOT FUNCTION.

  Patient problems: Insufficient Information

  MAUDE report 24637908 ↗
• MalfunctionFeb 26, 2026Failure to Align

  IT WAS REPORTED THAT INTRAOPERATIVELY, AS THE WARHEAD PASSED THROUGH THE INTESTINAL LOOP, THE ANVIL ROTATED AND ENDED UP LYING DOWN, PREVENTING THE PHYSICIAN FROM STAPLING. 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 24461743 ↗
• MalfunctionFeb 12, 2026Misfire; Failure to Form Staple

  IT WAS REPORTED THAT INTRAOPERATIVELY, INCOMPLETE FIRING OCCURRED. THE DONUT WAS INCOMPLETE. TO RESOLVE THE ISSUE, THE SURGERY WAS COMPLETED WITH ANOTHER CIRCULAR STAPLER.

  Patient problems: Failure to Anastomose

  MAUDE report 24327514 ↗
• InjuryFeb 9, 2026Mechanics Altered

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, WHILE DOING THE ANASTOMOSIS, THE DEVICE CUT BUT THE STAPLER PART OF THE GOOD DID NOT WORK. THE PROCEDURE TIME WAS EXTENDED BY OVER 60 MINUTES, AND A RE-ANASTOMOSIS WAS PERFORMED. THE PATIENT EXPERIENCED EXTENDED HOSPITALIZATION. THE DEVICE WAS REPLACED WITH ANOTHER BRANDED DEVICE TO RESOLVE THE ISSUE.

  Patient problems: Failure to Anastomose

  MAUDE report 24291653 ↗
• InjuryDec 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING COLON SURGERY, A COLORECTAL ANASTOMOSIS WAS PERFORMED USING A CIRCULAR STAPLER. AN AIR LEAK WAS DETECTED ON THE ANTERIOR ASPECT OF THE ANASTOMOSIS, CORRESPONDING TO THE AREA 180 DEGREES OPPOSITE THE STAPLER FIRING MECHANISM, DURING THE STANDARD AIR LEAK TEST. ISSUES WERE IDENTIFIED AFTER FIRING, INCLUDING LEAKS AT THE STAPLE LINE. REINFORCEMENT SUTURES WERE PLACED, BUT SUBSEQUENT LEAK TESTING REMAINED POSITIVE FOR LEAKAGE. AS A RESULT OF PERSISTENT ANASTOMOTIC LEAKAGE, A DIVERTING ILEOSTOMY WAS CREATED AND ADDITIONAL SURGERY WAS REQUIRED.

  Patient problems: Failure to Anastomose; Tissue Breakdown

  MAUDE report 23925461 ↗
• MalfunctionDec 30, 2025Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING A PROCEDURE, AFTER FIRING, AN INCOMPLETE STAPLE LINE OCCURRED. THE DEVICE WAS REPLACED WITH ANOTHER CIRCULAR STAPLER.

  Patient problems: Tissue Breakdown

  MAUDE report 23920881 ↗
• MalfunctionDec 4, 2025Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT DURING A COLECTOMY, THE STAPLER WAS ACTIVATED AND ONLY STAPLING OCCURRED WITHOUT CUTTING. THE DEVICE WAS REPLACED WITH ANOTHER OF THE SAME MODEL. NO CONSEQUENCES OR IMPACT TO THE PATIENT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23715404 ↗
• MalfunctionOct 29, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC RADICAL RESECTION OF COLORECTAL CANCER, WHEN ON COLON ANASTOMOSIS, THE SAFETY PIN BROKE. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23418141 ↗
• MalfunctionSep 30, 2025Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE STAPLE LINE WAS INCOMPLETE. SUTURING WAS PERFORMED AS A REPLACEMENT FOR THE STAPLE LINE. THE SURGICAL TIME WAS EXTENDED FOR AN HOUR AND A HALF LONGER THAN EXPECTED.

  Patient problems: Failure to Anastomose

  MAUDE report 23178311 ↗
• MalfunctionSep 12, 2025Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING A SIGMOID RESECTION, POOR STAPLE FORMATION WAS OBSERVED WITH BOTH THE STAPLER AND THE CIRCULAR STAPLER. SPECIFICALLY, POOR B-SHAPED STAPLE FORMATION WAS NOTED WHEN THE STAPLER WAS USED TO DETACH THE DESCENDING COLON, REQUIRING SUTURES TO REINFORCE THE STAPLE LINE. ADDITIONALLY, DURING THE ANASTOMOSIS OF THE DESCENDING COLON AND RECTUM WITH THE CIRCULAR STAPLER, POOR B-SHAPED STAPLE FORMATION WAS OBSERVED AGAIN, AND ADDITIONAL SUTURING WAS PERFORMED TO SECURE THE ANASTOMOSIS.

  Patient problems: Failure to Anastomose

  MAUDE report 23035684 ↗
• MalfunctionSep 9, 2025Failure to Align; Failure to Align

  IT WAS REPORTED THAT DURING A PROCEDURE WHEN ADJUSTING THE SUTURE, THE ANVIL WAS TILTED PREMATURELY AND WAS UNABLE TO USE ON THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 23002047 ↗
• MalfunctionSep 5, 2025Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING USE OF THE CIRCULAR STAPLER; AN INCOMPLETE STAPLE LINE (PARTIALLY FIRED) WERE IDENTIFIED. ANOTHER PRODUCT WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Failure to Anastomose

  MAUDE report 22983394 ↗
• MalfunctionAug 5, 2025Difficult to Remove; Failure to Cut; Difficult to Remove; Failure to Cut

  IT WAS REPORTED THAT DURING A PROCEDURE, THE DEVICE STAPLED BUT DID NOT CUT, AND THE ANVIL AT THE END OF THE CLAMP REMAINED BLOCKED. TO RESOLVE THE ISSUE, SUTURING WAS PERFORMED BY HAND. IT WAS NOTED THAT THE PROCEDURE TIME WAS EXTENDED.

  Patient problems: Tissue Breakdown

  MAUDE report 22716875 ↗
• MalfunctionJul 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A LOWER ANTERIOR RESECTION PROCEDURE, AFTER FIRING A LEAKING CONTENT WAS OBSERVED AT THE ANASTOMOSIS. A LEAK TEST WAS PERFORMED AND WAS NEGATIVE FOR AIR BUBBLES AND METHYLENE BLUE, BUT THE ANASTOMOSIS WAS STILL LEAKING CONTENT. SUTURING WAS REQUIRED AS A STAPLE LINE REPLACEMENT TO ADDRESS THE LEAK. THE SURGICAL TIME WAS EXTENDED FOR 40 MINS.

  Patient problems: Failure to Anastomose

  MAUDE report 22628220 ↗
• MalfunctionJun 30, 2025Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICE HAD A FAULTY CONNECTION BETWEEN THE ANVIL AND THE HOUSING, SO WHEN CLOSING THE ANVIL, IT SLIPPED AND COULD NOT BE OPERATED ON. ANOTHER CIRCULAR STAPLER WAS OPENED TO SOLVE THE ISSUE. SURGICAL TIME WAS EXTENDED BY 30 MINUTES DUE TO PRODUCT REPLACEMENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22357515 ↗
• MalfunctionJun 26, 2025Failure to Cut; Adverse Event Without Identified Device or Use Problem; Failure to Cut; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A LOW ANTERIOR RESECTION (LAR), THE DEVICE DID NOT CUT THE TISSUE SMOOTHLY, THERE WAS A JAGGED LINE. A NEW RELOAD WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Failure to Anastomose

  MAUDE report 22342912 ↗
• MalfunctionJun 25, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC RADICAL SURGERY FOR LOW RECTAL CANCER, WHILE PERFORMING RECTO COLONIC ANASTOMOSIS RECONST RUCTION, THE CIRCULAR STAPLER HANDLE COULD NOT BE PULLED AND PRESSED, RESULTING IN THE INABILITY TO PUSH OUT STAPLES AND BLADE. THE DEVICE WAS ALSO DIFFICULT OR UNABLE TO CLOSE. THE ISSUE WAS RESOLVED BY REPLACING THE DEVICE 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 22328520 ↗
• MalfunctionJun 18, 2025Misfire; Failure to Fire; Misfire; Failure to Fire

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC SIGMOIDECTOMY, THE DEVICE MISFIRE, WHICH RESULTED IN EXTENDED SURGICAL TIME. DUE TO THE DEVICE MALFUNCTION, THE SURGICAL TEAM CONVERTED TO MANUAL SUTURING AS A STAPLE LINE REPLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Tissue Breakdown

  MAUDE report 22283255 ↗
• MalfunctionJun 17, 2025Difficult to Remove; Failure to Form Staple; Difficult to Remove; Failure to Form Staple

  ACCORDING TO THE REPORTER DURING A BOWEL RECONSTRUCTION SURGERY FOLLOWING A HARTMANN SURGERY FOR NEO-PLASIA, THERE WAS FAILURE ON CO LORECTAL STAPLING. IT WAS NOTED THAT THE CIRCULAR STAPLER WAS CONNECTED, CLOSED UNTIL GREEN SIGNAL, SAFETY LOCK RELEASED AND WHEN PRESSING TO STAPLE, THE CIRCULAR STAPLER GOT LOCKED NOT CLOSING OR OPENING. THE STAPLER WAS THEN OPENED, CONSEQUENTLY OPENING THE COLON AND RECTUM WITHOUT CLOSING OF STAPLES. ANASTOMOSIS BY PULL THROUGH TECHNIQUE WITH MANUAL COLOANAL ANASTOMOSIS WAS DONE TO RESOLVE THE ISSUE.

  Patient problems: Failure to Anastomose

  MAUDE report 22224955 ↗
• MalfunctionJun 16, 2025Difficult to Remove; Failure to Form Staple; Difficult to Remove; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SIGMOID COLECTOMY, WHEN USING THE NEW CIRCULAR STAPLER TO ANASTOMOSE THE DESCENDING COLON AND RECTUM, POOR STAPLE FORMATION WAS OBSERVED AND THE SUTURE WAS SUBSEQUENTLY USED TO REINFORCE STITCHING. IT WAS NOTED THAT THE ANVIL DID NOT TILT AFTER FIRING.

  Patient problems: Failure to Anastomose

  MAUDE report 22214637 ↗