Tri-Staple 2.0 SIGCIR28MTRecalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 10884521703728), received between Aug 1, 2025 and Sep 23, 2026 — classified as 1 death, 6 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Failure to Align” (6 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2026Difficult to Remove; Detachment of Device or Device Component

  It was reported that during a robotic-assisted left colectomy, the device was fired and the screen showed the anvil was tilting before removal. After removal, the device was examined and the reload had become detached from the adapter. The reload came off as the integrated trocar extended and prevented the anvil from tilting. After troubleshooting, the reload was able to be returned to the adapter and allowed the anvil to tilt normally. No patient harm or complications. After the case, the adapter and handle were tested with a fresh reload without any issues.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50863570 ↗
• MalfunctionSep 21, 2026Patient Device Interaction Problem

  According to the reporter, during a laparoscopic sigmoidectomy, the physician discharged the circular stapler despite having a part of the tissue under extreme tension, causing a tear in the proximal tissue. Suturing was done as staple line reinforcement.

  Patient problems: Tissue Breakdown

  MAUDE report 50840032 ↗
• InjurySep 17, 2026Mechanics Altered

  According to the reporter, intra-operatively of an exploratory laparotomy with low anterior resection, the stapler cut the tissue but did not staple it. The surgeon was able to perform a hand anastomosis. Additionally, during the procedure, the patient underwent three separate colonoscopies due to anastomotic leak. The patient was noted to have large volume of ascites which was drained. Postoperatively, the midline fascia was closed with a black foam sponge placed and incision. There was an estimated blood loss of 600cc.

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

  MAUDE report 50801103 ↗
• MalfunctionAug 12, 2026Failure to Align

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50224614 ↗
• InjuryJun 22, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, FOLLOWING A BENIGN PROCEDURE FOR DIVERTICULITIS, A PATIENT WITH A MEDICAL HISTORY OF DIVERTICULITIS AND CARDIOVASCULAR DISEASE AND PRIOR ABDOMINAL AND COLORECTAL SURGERIES DEVELOPED AN ANASTOMOTIC LEAK. POST-PROCEDURE, THE PATIENT HAD A FEVER OF 101.5°F ON POST-OPERATIVE DAY 5 WITH A PERI-ANASTOMOTIC GAS COLLECTION MEASURING 3.5 × 3.5 CM. COMPUTED TOMOGRAPHY (CT SCAN) OF THE ABDOMEN AND PELVIS WITH INTRAVENOUS CONTRAST WAS PERFORMED AND SURGERY CONFIRMED A SMALL ANASTOMOTIC DEFECT CONSISTENT WITH A GRADE C ANASTOMOTIC LEAK REQUIRING OPERATIVE INTERVENTION. THE EVENT WAS SERIOUS AND INVOLVED PROLONGATION OF AN EXISTING HOSPITALIZATION. THE PATIENT UNDERWENT DIAGNOSTIC LAPAROSCOPY WITH DIVERTING LOOP ILEOSTOMY, AND MEDICATION CHANGES WERE REPORTED. THE INVESTIGATOR AND SPONSOR ASSESSED THE EVENT AS HAVING A CAUSAL RELATIONSHIP TO THE STUDY PROCEDURE AND AS POSSIBLY RELATED TO THE STUDY DEVICE.

  Patient problems: Failure to Anastomose; Fever; Unintended Radiation Exposure; Unspecified Infection

  MAUDE report 25578637 ↗
• MalfunctionJun 14, 2026Difficult to Remove; Failure to Align; Failure to Cut

  ACCORDING TO THE REPORTER, DURING A LOW ANTERIOR RESECTION WITH END-TO-END ANASTOMOSIS, DURING FIRING OF THE POWERED CIRCULAR STAPLER, THE SURGEON RECEIVED A KNIFE/CUTTING ERROR SYMBOL AFTER THE STAPLES HAD BEEN FORMED. UPON RECEIVING THE ERROR, THE DEVICE WAS UNABLE TO CONTINUE WITH THE FIRING. THE USER TROUBLESHOOTS THE DEVICE WHICH ALLOWED THE ANVIL TO TILT EVEN THOUGH THE STAPLER DID NOT COMPLETE THE CUT. THE STAPLER REACHED 100% AND ALLOWED THE USER TO FIRE IN ZONE 3. ONCE STAPLER WAS REMOVED THE INSTRUMENT WAS BROKEN DOWN AND REASSEMBLED. WITH FORCE, THE SURGEON WAS ABLE TO RIP THE ANVIL OUT OF THE ANASTOMOSIS WHERE IT REMAINED ATTACHED VIA DONUTS. FROM THERE, THE PARTIAL ANASTOMOSIS WAS CUT OUT OF THE PATIENT AND REPLACED WITH A MANUAL CIRCULAR STAPLER. DURING THIS TIME, THE ADAPTER REQUESTED A REBOOT WHICH WAS FOLLOWED AND UPON REASSEMBLY NO LONGER SHOWED ANY ERRORS AND RECOGNIZED THE USED LOAD ONCE IT WAS ATTACHED TO THE HANDPIECE. THE SURGICAL TIME WAS EXTENDED BY 60 MINUTES.

  Patient problems: Failure to Anastomose; Tissue Breakdown

  MAUDE report 25497843 ↗
• InjuryMay 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, FOLLOWING A COLOSTOMY TAKEDOWN PROCEDURE ON (B)(6) 2026, A SERIOUS POST-PROCEDURE PERIOPERATIVE DEHISCENCE OF THE ABDOMINAL WOUND WITH EVISCERATION OCCURRED. THE PATIENT WAS PRESENTED TO AN EMERGENCY DEPARTMENT AFTER NOTICING ¿SOMETHING POKING OUT¿ WHILE CHANGING THE DRESSING. A COMPUTED TOMOGRAPHY SCAN OF THE ABDOMEN AND PELVIS WITH INTRAVENOUS CONTRAST SHOWED A NEW SPIGELIAN HERNIA CONTAINING A SMALL BOWEL SEGMENT, WITH THE SMALL BOWEL CONTACTING AND PROJECTING SLIGHTLY BEYOND THE SKIN SURFACE, ALONG WITH MURAL EDEMA AND PNEUMATOSIS THAT RAISED CONCERN FOR BOWEL ISCHEMIA, AND THERE WAS ALSO CONCERN FOR A SUSPECTED ABSCESS THAT WAS NOT DRAINABLE. THE EVENT REQUIRED A NEW HOSPITALIZATION ON (B)(6) 2026 AND SURGICAL TREATMENT FOR EVISCERATION OF THE COLOSTOMY CLOSURE SITE WITH A LOOP OF SMALL BOWEL EVISCERATED; ALL BOWEL WAS REPORTED VIABLE, AND FASCIAL CLOSURE WITH VICRYL MESH UNDERLAY WAS PERFORMED. MEDICATION CHANGES WERE MADE DUE TO THE ADVERSE EVENT. THE SPONSOR ASSESSED THE EVENT AS POSSIBLY RELATED TO THE STUDY PROCEDURE AND POSSIBLY RELATED TO THE STUDY DEVICE. THE OUTCOME WAS REPORTED AS RECOVERING/RESOLVING.

  Patient problems: Hernia; Swelling/ Edema; Wound Dehiscence

  MAUDE report 25101460 ↗
• MalfunctionApr 20, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A LOW ANTERIOR RESECTION PROCEDURE, A STAPLE LINE HAD A LEAK FROM THE PROXIMAL TRANSECTION AFTER FIRING, A LEAK TEST WAS PERFORMED AND WAS POSITIVE (AIR BUBBLES OR METHYLENE BLUE), AND IT WAS REPORTED THAT THE ANASTOMOSIS WAS NOT LEAKING CONTENT. THERE WAS NO PATIENT INJURY.

  Patient problems: Tissue Breakdown

  MAUDE report 24933932 ↗
• MalfunctionApr 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER FIRING OF CIRCULAR STAPLER, THERE WAS A LEAK FROM THE DISTAL STAPLE LINE. A LEAK TEST WAS PERFORMED AND WAS POSITIVE TO AIR BUBBLES. SUTURING WAS PERFORMED AS STAPLE LINE REINFORCEMENT TO ADDRESS THE LEAK.

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

  MAUDE report 24880829 ↗
• MalfunctionApr 14, 2026Failure to Align

  IT WAS REPORTED THAT DURING A ROBOTIC LAPAROSCOPIC COLOSTOMY REVERSAL, THE SURGEON CLOSED THE DEVICE DURING THE ANASTOMOSIS STEP AND THEN REALIZED THE COLON HAD TWISTED. THE SURGEON HELD UP ON THE TRIGGER TO CREATE SPACE TO STRAIGHTEN THE COLON, AND THE ANVIL TILTED. THE SURGEON THEN PARTIALLY OPENED THE DEVICE TO AVOID FULLY TILTING THE ANVIL, APPLIED PRESSURE WHILE CLOSING THE POWER CIRCULAR DEVICE, AND CONTINUED THE NORMAL FIRING PROCESS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24874661 ↗
• MalfunctionApr 7, 2026Human-Device Interface Problem; Incomplete or Inadequate Connection

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SIGMOID COLECTOMY, ANVIL TROCAR TIP WAS UNABLE TO BE INSERTED TO ANVIL CENTER ROD AND UNABLE TO BE ATTACHED. THE HANDLE WAS REPLACED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24799421 ↗
• MalfunctionMar 20, 2026Failure to Align

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC SIGMOID COLECTOMY, A TWISTED COLON WAS IDENTIFIED WHILE CONNECTING THE POWERED CIRCULAR STAPLER TO THE ANVIL. THE SURGEON CLOSED THE STAPLER AND REACHED 100%, AT WHICH POINT THE TWISTED COLON WAS NOTICED. THE SURGEON DISENGAGED THE CLOSURE, AND UPON PRESSING THE UP BUTTON, THE ANVIL BECAME TILTED. THE SURGEON MANUALLY REPOSITIONED THE ANVIL TO ITS NON-TILTED POSITION AND FIRED THE DEVICE. A BUBBLE TEST WAS PERFORMED, AND THE RESULTS WERE SATISFACTORY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24647918 ↗
• MalfunctionFeb 24, 2026Break; Failure to Align

  IT WAS REPORTED THAT DURING A ROBOTIC LAPAROSCOPIC BOWEL RESECTION FOR ENDOMETRIOSIS REMOVAL, DURING BOWEL RESECTION, THE ANVIL BROKE AND IT TILTED OR FLIPPED PRIOR TO FIRING. THE BROKEN PART DID NOT DISENGAGE. THE DEVICE WAS REPLACED BY OPENING A NEW RELOAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24429653 ↗
• DeathFeb 19, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT NO DEVICE ISSUES WITH THE POWERED CIRCULAR STAPLER WERE REPORTED DURING THE LAPAROSCOPIC LOW ANTERIOR RESECTION; HOWEVER, POSTOPERATIVELY, A PATIENT EXPERIENCED A PERFORATION IN THE RECTUM SEVERAL DAYS AFTER SURGERY, AS WELL AS ANASTOMOTIC LEAKAGE. THE PATIENT WAS READMITTED TO THE HOSPITAL AND SUBSEQUENTLY ADMITTED TO THE INTENSIVE CARE UNIT. AN ADDITIONAL SURGICAL PROCEDURE WAS PERFORMED AS TREATMENT. THE PATIENT'S PROGNOSIS WAS NOT GOOD, LEADING THE FAMILY TO DECIDE THAT THE VENTILATOR BE TAKEN OFF THE PATIENT. THE PATIENT PASSED AWAY.

  Patient problems: Confusion/ Disorientation; Diarrhea; Failure to Anastomose; Perforation; Tachycardia; Unintended Radiation Exposure

  MAUDE report 24387400 ↗
• MalfunctionFeb 4, 2026Misfire; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE POWERED HANDLE DISPLAYED A WARNING SCREEN FOR POTENTIAL OBSTRUCTION. IT WAS EVENTUALLY RESOLVED AND ENTERED THE COMPRESSION PHASE AND SUBSEQUENT FIRING WITHOUT AN ISSUE. THE PROXIMAL TISSUE RING WAS INCOMPLETE. ANASTOMOSIS DISPLAYED A LEAK ON THE BUBBLE TEST. THE POWERED HANDLE RECOMMENDED EXTENDING THE SPIKE, WHICH THE SURGEON DID, THEN FOLLOWED NORMAL PROCEDURE STEPS WITHOUT ISSUE. THE ANASTOMOSIS WAS REMOVED, AND A NEW STAPLE LINE WAS CREATED WITH A COMPETITOR'S CIRCULAR STAPLER; HOWEVER, THE PROXIMAL DONUT WAS INCOMPLETE AGAIN, BUT NO LEAK WAS OBSERVED DURING THE SUBSEQUENT BUBBLE LEAK TEST.

  Patient problems: Failure to Anastomose

  MAUDE report 24256947 ↗
• InjuryJan 22, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A POST-OPERATIVE STRICTURE OCCURRED IN ASSOCIATION WITH THE POWERED CIRCULAR STAPLER.

  Patient problems: Stenosis

  MAUDE report 24153132 ↗
• InjuryNov 3, 2025Misfire; Misfire

  IT WAS REPORTED THAT DURING THE ROBOTIC SIGMOID COLON PROCEDURE FOR A PATIENT WITH A HISTORY OF COLON CANCER, IN THE FINAL STEP FOR END-TO-END ANASTOMOSIS. AN INCOMPLETE DISTAL DONUT WAS OBSERVED, WHILE THE PROXIMAL DONUT WAS FULLY INTACT. DUE TO CONCERN FOR ANASTOMOTIC INTEGRITY RELATED TO THE INCOMPLETE DISTAL DONUT, A LEAK TEST WAS PERFORMED POST FIRING AND WAS NEGATIVE WITH NO BUBBLES. DESPITE THE NEGATIVE LEAK TEST, THE SURGEON REMAINED CONCERNED AND DECIDED TO DIVERT TO A TEMPORARY COLOSTOMY AS AN ADDITIONAL INTERVENTION.

  Patient problems: Failure to Anastomose; Tissue Breakdown

  MAUDE report 23459594 ↗
• MalfunctionNov 3, 2025Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER IN A ROBOTIC LAPAROSCOPIC SIGMOIDECTOMY, AFTER FIRING THE CIRCULAR STAPLER DURING ANASTOMOSIS, THERE WAS POOR STAPLE FORMATION. THE STAPLES WERE UNFORMED AND HAD STRAIGHT LEGS. SUTURING AS A STAPLE LINE REINFORCEMENT TO RESOLVE THE ISSUE.

  Patient problems: Failure to Anastomose

  MAUDE report 23452200 ↗
• MalfunctionSep 5, 2025Device Displays Incorrect Message; Detachment of Device or Device Component; Human-Device Interface Problem; Device Displays Incorrect Message; Detachment of Device or Device Component; Human-Device Interface Problem

  IT WAS REPORTED THAT DURING A ROBOTIC ASSISTED LOW ANTERIOR RESECTION, AFTER FIRING THE  POWERED CIRCULAR STAPLER TO CREATE THE ANASTOMOSIS BUT PRIOR TO REMOVAL FROM THE RECTUM, SEVERAL ISSUES WERE OBSERVED. THE SURGEON ATTEMPTED TO USE THE IRRIGATION CHANNEL TO BLOW AIR INTO THE COLON TO CHECK FOR A LEAK. UPON REMOVAL OF THE DEVICE, IT WAS NOTED THAT THE TILT TOP ANVIL WAS NOT FULLY EXTENDED AND NOT TILTED. FURTHER INSPECTION REVEALED THAT THE RELOAD CARTRIDGE (PURPLE 28) HAD MIGRATED AWAY FROM THE FULLY LOCKED POSITION IT WAS IN BEFORE INSERTION, AND THE TILT OF THE ANVIL WAS NOT VISIBLE DUE TO THE MIGRATION OF THE RELOAD OFF THE DISTAL TIP OF THE POWERED CIRCULAR ADAPTER. ADDITIONALLY, DURING CLAMPING, THE DEVICE DISPLAYED A CAUTION MESSAGE FOR HIGH PRESSURE MULTIPLE TIMES, REQUIRING PAUSES AND RE-CLAMPING UNTIL IT REACHED 100% AND WAS ABLE TO FIRE.

  Patient problems: Failure to Anastomose; Tissue Breakdown

  MAUDE report 22978177 ↗
• InjuryAug 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, SIX DAYS POST-OPERATIVE OF A SIGMOID COLECTOMY WHERE A POWERED CIRCULAR STAPLER WAS USED TO CREATE ANASTO MOSIS, THE WHITE BLOOD CELLS OF THE PATIENT ELEVATED FROM 9 TO 14.7. A COMPUTED TOMOGRAPHY (CT) SCAN OF THE ABDOMEN AND PELVIS WITH INTRAVENOUS (IV) AND RECTAL CONTRAST SHOWED THAT THE PATIENT HAD LEAK AT THE COLORECTAL ANASTOMOSIS. THE PATIENT WAS TAKEN TO THE OPERATING ROOM AND THE ANTERIOR PORTION OF THE ANASTOMOSIS HAD DEHISCED. THE DEHISCED PORTION WAS RESECTED AND A COLOSTOMY WAS BROUGHT UP. THE PATIENT WAS BROUGHT TO THE INTENSIVE CARE UNIT POST-OPERATIVELY. THE PATIENT'S HOSPITALIZATION WAS EXTENDED AS A RESULT.

  Patient problems: Failure to Anastomose; High White Blood Cell Count; Tissue Breakdown

  MAUDE report 22790458 ↗
• MalfunctionAug 1, 2025Failure to Align; Failure to Align

  ACCORDING TO THE REPORTER, IN A LAPAROSCOPIC ROBOT ASSISTED LOWER ANTERIOR RESECTION, THE PROCEDURE BEGAN WITH A 28 MM PURPLE RELOAD. THE COMPRESSION ACHIEVED WAS 100% IN ZONE 3, BUT IN PURSUIT OF OPTIMAL STAPLING RESULTS, THE SURGEON ELECTED TO SWITCH TO A BLACK 28 MM RELOAD. THE ANVIL FROM THE ORIGINAL PURPLE 28 MM RELOAD WAS RETAINED FOR USE. UPON CLOSING THE ANVIL, AN OBSTRUCTION ALERT WAS TRIGGERED. DURING UNCLAMPING, IT WAS NOTED THAT THE ANVIL HAD TILTED. DUE TO CONCERNS REGARDING PROCEEDING WITH A TILTED ANVIL, THE SURGEON OPTED TO REPLACE IT WITH THE ANVIL FROM THE BLACK 28 MM RELOAD. COMPRESSION WAS THEN ACHIEVED AT 100% IN ZONE 2 AND STAPLING WAS COMPLETED SUCCESSFULLY WITH THE BLACK 28 MM. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22684094 ↗