Tri-Staple 2.0 SIGCIR28XTRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10884521703735), received between Aug 21, 2025 and Apr 29, 2026 — classified as 2 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Failure to Align” (3 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 29, 2026Device Difficult to Setup or Prepare; Failure to Align

  IT WAS REPORTED THAT DURING A SIGMOID COLON SURGERY, DURING USE OF THE CIRCULAR STAPLER WHILE CLOSING THE DEVICE, THE ANVIL HAD SLIPPED OUT OF THE PURSESTRING AND IT CAME UNDONE. THE SURGEON PAUSED AND OPENED THE DEVICE TO REMOVE THE ANVIL FROM THE SPIKE TO RE-DO THE PURSESTRING WHILE THE DEVICE WAS NOT FULLY CLOSED. WHEN THE DEVICE WAS OPENED, THE ANVIL TILTED PRIOR TO FIRING AND HAD NOT BEEN FULLY CLOSED. ANOTHER RELOAD WAS OPENED TO REPLACE THE ANVIL AND RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25032036 ↗
• MalfunctionApr 2, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC SIGMOID COLON RESECTION ON END-TO-END ANASTOMOSIS, THE PROCEDURE WAS EXTENDED BY 30 MINUTES DUE TO A CASE INVOLVING VERY THICK, POOR, ADHESED TISSUE. AFTER FIRING THE STAPLER, A LEAK TEST WAS PERFORMED, WHICH WAS POSITIVE FOR AIR BUBBLES/METHYLENE BLUE. AS A RESULT, ADDITIONAL SIGMOID COLON TISSUE WAS MOBILIZED AND RESECTED, AND A SECOND ANASTOMOSIS WAS PERFORMED USING A SECOND RELOAD WITH NO ISSUES.

  Patient problems: Failure to Anastomose; Tissue Breakdown

  MAUDE report 24764336 ↗
• MalfunctionMar 30, 2026Misfire; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN OPEN COLOSTOMY REVERSAL PROCEDURE USING THE CIRCULAR STAPLER, A LEAK OCCURRED DURING THE END-TO-END ANASTOMOSIS STEP. AN INCOMPLETE TISSUE DONUT WAS OBSERVED AFTER STAPLING. THE PROCEDURE WAS EXTENDED BY 35 MINUTES, AND THE RECTUM WAS RESECTED AND RE-STAPLED TO PERFORM ANOTHER END-TO-END ANASTOMOSIS. A MANUAL ENDOSCOPIC 28MM BLACK LINEAR STAPLER WAS USED FOR THE ANASTOMOSIS.

  Patient problems: Failure to Anastomose; Tissue Breakdown

  MAUDE report 24716553 ↗
• MalfunctionMar 26, 2026Difficult to Remove

  IT WAS REPORTED THAT DURING AN OPEN COLOSTOMY TAKEDOWN, WHILE ON RECTAL END-TO-END ANASTOMOSIS STEP, THE STAPLER WAS REPORTED TO BE DIFFICULT TO REMOVE FROM THE CAVITY, WHICH EXTENDED THE SURGICAL TIME BY 60 MINUTES. THE SURGEON INSTRUCTED A FELLOW TO REMOVE THE STAPLER FOLLOWING STANDARD PROTOCOLS. RESECTION AND RE-STAPLING WERE PERFORMED TO RESOLVE THE ISSUE.

  Patient problems: Failure to Anastomose; Tissue Breakdown

  MAUDE report 24705940 ↗
• MalfunctionMar 19, 2026Incomplete or Inadequate Connection

  ACCORDING TO THE REPORTER, DURING A ROBOTIC-ASSISTED SURGICAL (RAS) SIGMOID COLECTOMY WITH COLOVESICAL FISTULA TAKEDOWN, THE SPIKE WOULD NOT PROPERLY CONNECT TO THE ANVIL AND THE POWERED HANDLE WOULD NOT RECOGNIZE THAT IT WAS CONNECTED TO MEASURE THE ADAPTIVE COMPRESSION TECHNOLOGY. THE SURGEON HAD TO APPLY PRESSURE TO REMOVE THE ANVIL FROM THE SPIKE BUT COULD NOT SUCCESSFULLY PROCEED TO THE NEXT STEP ON THE SCREEN. TO RESOLVE THE ISSUE, A NEW MANUAL CIRCULAR STAPLER WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24636580 ↗
• InjuryMar 9, 2026Misfire; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE COLOSTOMY TAKEDOWN ROBOTIC PROCEDURE, A MULTIPLE HOLES WERE MADE IN THE SMALL BOWEL AND REPAIRED DURING THE PROCEDURE. AT THE TIME OF THE ANASTOMOSIS, THE CIRCULAR STAPLER SIZERS COULD NOT REACH THE END OF THE RECTAL STUMP, AND THE CIRCULAR STAPLER WAS APPLIED REGARDLESS. THE RESIDENT ROBOTICALLY HELD UP EACH CORNER OF THE RECTAL STUMP, RESULTING IN HOLES BEING RIPPED IN THE CORNERS OF THE RECTUM. THE SURGEON EXTENDED THE SPIKE THROUGH ONE OF THE HOLES AND FIRED THE CIRCULAR STAPLER, WHICH PRODUCED AN INCOMPLETE DONUT ON THE ANVIL SIDE AND A THIN DONUT ON THE CIRCULAR SIDE. THE SURGEON INSPECTED THE SMALL BOWEL AND PERFORMED A LEAK TEST, WHICH FAILED, INDICATING ANASTOMOTIC LEAKAGE. THE PROCEDURE WAS CONVERTED FROM ROBOTIC LAPAROSCOPIC TO OPEN, AND THE SURGEON SUTURED THE HOLE CLOSED, PERFORMED A LOOP ILEOSTOMY, AND CONDUCTED A SMALL BOWEL RESECTION. EXTENDED SURGICAL TIME WAS NOTED.

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

  MAUDE report 24552461 ↗
• MalfunctionFeb 13, 2026Failure to Align

  IT WAS REPORTED THAT DURING A SPINE PROCEDURE, THE ANVIL MALFUNCTIONED, TILTING AS IF IT WAS FIRED WHEN REOPENING THE STAPLER, WHICH NECESSITATED REDOING THE ENTIRE ANASTOMOSIS. THE PROCEDURE WAS EXTENDED BY 35 MINUTES DUE TO AN INSTRUMENT BREAK. THE DEVICE WAS REPLACED AND ANOTHER CARTRIDGE WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Failure to Anastomose; Tissue Breakdown

  MAUDE report 24334905 ↗
• MalfunctionJan 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A ROBOTIC LAPAROSCOPIC SIGMOID COLECTOMY, AFTER FIRING, A LEAK TEST WAS PERFORMED AND THE RESULT CAME BACK AS POSITIVE. THE SURGEON RESECTED, RE-DOCK THE ROBOT AND RE-STAPLED THE ANASTOMOSIS TO RESOLVE THE ISSUE. THE SURGICAL RIME WAS EXTENDED BY AN HOUR.

  Patient problems: Failure to Anastomose

  MAUDE report 24183742 ↗
• InjuryJan 14, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS GIVEN AN ANTICOAGULANT ONE HOUR BEFORE A LAPAROSCOPIC HAND-ASSISTED SIGMOID RESECTION. DURING THE PROCEDURE, THE SURGEON UTILIZED A REVERSE BAKER TECHNIQUE AND A BLACK CIRCULAR RELOAD, WITH THE STAPLER CLOSED TO 98% AND THEN 100% AT THE TOP END OF ZONE 2, AND REMOVED THE STAPLER WITHOUT RESISTANCE. THE RECTAL STUMP WAS NOT SKELETONIZED, AND VISIBLE VISCERAL FAT WAS PRESENT AT THE ANASTOMOSIS SITE. FORTY MINUTES AFTER THE PROCEDURE, SIGNIFICANT RECTAL BLEEDING WAS OBSERVED IN THE POST-ANESTHESIA CARE UNIT, WITH A TOTAL BLOOD LOSS OF 450 MILLILITERS. THE SURGEON HAD TO BRING THE PATIENT BACK TO THE OPERATING ROOM FOR REVISION OF THE ANASTOMOSIS USING ANOTHER MANUFACTURER'S CIRCULAR STAPLER. IT WAS NOTED THAT THE BLEEDING OCCURRED AT THE SITE OF THE COLON ANASTOMOSIS. UPON INSPECTION OF THE ANASTOMOTIC SPECIMEN, SIGNIFICANT CLOTTING WAS OBSERVED INSIDE THE ANASTOMOSIS, BUT THE STAPLE LINES APPEARED COMPLETELY INTACT. ON POST-OPERATIVE DAY ONE, THE PATIENT WAS REPORTED TO BE DOING FINE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Tissue Breakdown

  MAUDE report 24073784 ↗
• MalfunctionAug 21, 2025Failure to Align; Failure to Align

  IT WAS REPORTED THAT DURING A ROBOTIC LAPAROSCOPIC PROCEDURE FOR ANASTOMOSIS, WHEN THE DEVICE WAS BEING APPLIED TO THE COLON DURING THE CONNECTION OF THE RECTAL STUMP TO THE SIGMOID, THE SUTURE POPPED DURING SEATING OF THE RELOAD TO THE ANVIL, REQUIRING THE PURSESTRING TO BE RECREATED. THE ANVIL TILTED PRIOR TO FIRING, AND A NEW ANVIL HAD TO BE INSERTED. THE SURGICAL TIME WAS EXTENDED BY 20 MINUTES. THE ANVIL 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 22867954 ↗