BEUDAMED
    FDA Adverse Event Death Summary report: N

    TRI-STAPLE 2.0

    MDR report key: 24387400 · Received February 19, 2026

    Report

    Report Number
    1219930-2026-01149
    Event Type
    Death
    Date Received
    February 19, 2026
    Date of Event
    January 21, 2026
    Report Date
    April 28, 2026
    Manufacturer
    COVIDIEN SURGICAL
    Product Code
    GDW
    UDI-DI
    10884521703728
    PMA / PMN Number
    K182475
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: B5, E1, E3, G3, H3, H6. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: G3, H3, H6 H3 EVALUATION SUMMARY: MEDTRONIC CONDUCTED AN INVESTIGATION BASED UPON ALL INFORMATION RECEIVED. THE INVOLVED DEVICE WAS NOT RETURNED. HOWEVER, A VIDEO WAS PROVIDED. VISUAL INSPECTION SHOWED THE INSIDE OF A PATIENT THROUGH A SCOPE. GRASPERS WERE USED TO MANIPULATE THE COLON. NO LEAKS COULD BE SEEN IN THE VIDEO. IT WAS REPORTED THAT THERE WAS STAPLE LINE CONTENT LEAK. THE REPORTED ISSUE COULD NOT BE CONFIRMED. THE MOST LIKELY CAUSE COULD NOT BE ESTABLISHED FROM THE INFORMATION AVAILABLE. THE MANUFACTURING RECORDS FOR EACH DEVICE ARE THOROUGHLY REVIEWED PRIOR TO RELEASE TO ENSURE THAT IT MEETS ALL MEDTRONIC QUALITY SPECIFICATIONS. A SECONDARY REVIEW OF THE DEVICE HISTORY RECORDS FOUND NO POTENTIALLY CONTRIBUTING FACTORS. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Additional Manufacturer Narrative · 0

    D10 CONCOMITANT PRODUCT: SIGPHANDLE, SIG POWER SIGPHANDLE HANDLE (SERIAL#: UNKNOWN). MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT NO DEVICE ISSUES WITH THE POWERED CIRCULAR STAPLER WERE REPORTED DURING THE LAPAROSCOPIC LOW ANTERIOR RESECTION; THE PATIENT WAS READMITTED FOUR TO FIVE DAYS LATER DUE TO CONFUSION, ELEVATED HEART RATE, AND DIARRHEA. COMPUTED TOMOGRAPHY (CT) SCANS WERE DONE TO SEE IF THERE WAS FLUID BUILD UP IN THE PELVIS NEAR ANASTOMOSIS. FLUID TESTS WERE ALSO DONE TO SEE IF LIQUID CONTAINED BOWEL CONTENTS. MINOR FLUID BUILDUP WAS OBSERVED IN THE PELVIS AND FLUID TESTS WERE RUNNING CLEAR WITHOUT BOWEL CONTENTS. THE PATIENT WAS CONTINUED TO BE MONITORED TO ENSURE STABILITY, AND A SECOND ROUND OF THE SAME TESTS WERE PERFORMED, WHICH CAME BACK SHOWING MORE SIGNIFICANT BUILD UP OF FLUID IN THE PELVIS. IT WAS THEN DECIDED THAT EMERGENT RE-OPERATION WAS NEEDED, WHERE PERFORATION IN THE RECTUM AND ANASTOMOTIC LEAKAGE WAS CONFIRMED. CLOSURE OF THE PERFORATION WAS PERFORMED. THE PATIENT WAS SUBSEQUENTLY ADMITTED TO THE INTENSIVE CARE UNIT. THE PATIENT'S PROGNOSIS WAS NOT GOOD, LEADING THE FAMILY TO DECIDE THAT THE VENTILATOR BE TAKEN OFF THE PATIENT. THE PATIENT PASSED AWAY.

    Description of Event or Problem · 0

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384599 TRI-STAPLE 2.0 STAPLE, IMPLANTABLE GDW COVIDIEN SURGICAL SIGCIR28MT N5K1404UY 10884521703728

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other| R| H| D SEE NOTE ON H11.