BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHICON

    MDR report key: 3202293 · Received June 26, 2013

    Report

    Report Number
    MW5030703
    Event Type
    Injury
    Date Received
    June 26, 2013
    Date of Event
    June 4, 2013
    Report Date
    June 26, 2013
    Manufacturer
    ETHICON
    Product Code
    GAG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING PROCEDURE, STAPLER FIRED NORMALLY DIAL WAS TURNED TO LOOSEN STAPLE. GENTLE ROTATION OF INSTRUMENT FAILED TO RELEASE STAPLER. STAPLER WAS LOOSENED ANOTHER QTR TURN AND AGAIN GENTLY WIGGLED BACK/FORTH AND TISSUE DID NOT RELEASE. NUMEROUS ATTEMPTS MADE TO OPEN AND CLOSE THE DIAL OF STAPLER, NO SUCCESS IN RELEASING TISSUES. STAPLER FURTHER OPENED, AND WHEN PULLED BACK, THERE WAS IMMEDIATE RELEASE OF BOWEL CONTENT INTO PELVIS INDICATING DEHISCENCE OF ANASTOMOSIS. STAPLER REMOVED COLOSTOMY PERFORMED INSTEAD OF ANASTOMOSIS AS PLANNED. DIAGNOSIS OR REASON FOR USE: SIGMOID COLECTOMY, REPAIR OF FISTULA. EVENT ABATED AFTER USE? YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290268 ETHICON ILS CIRCULAR STAPLER GAG ETHICON ECS29A

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization