BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETHICON ENDO-SURGERY LLC.

    MDR report key: 12868645 · Received November 24, 2021

    Report

    Report Number
    12868645
    Event Type
    Malfunction
    Date Received
    November 24, 2021
    Date of Event
    November 11, 2021
    Report Date
    November 12, 2021
    Manufacturer
    ETHICON ENDO-SURGERY, LLC
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    MID 20¿S MALE WITH RECENT MANUAL VACUUM ASPIRATION (MVA) AND CT CONFIRMING PELVIC ABSCESS AND FISTULA AND BOWEL PERFORATION. PROCEDURE: EXPLORATORY LAP, PARTIAL COLECTOMY END COLOSTOMY AND APPENDECTOMY. STAPLER WORKED IN SURGERY, BUT UNABLE TO REMOVE STAPLER LOAD TO REPLACE IT WITH A NEW ONE. A DIFFERENT ETHICON CURVED CUTTER USED TO FINISH PROCEDURE. NO KNOWN HARM TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1769174 ETHICON ENDO-SURGERY LLC. STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC V94V83

    Patients

    Seq Age Sex Outcome Treatment
    1 9125 DA Male