BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETHICON ENDO SURGERY LLC

    MDR report key: 2916374 · Received January 9, 2013

    Report

    Report Number
    MW5028584
    Event Type
    Malfunction
    Date Received
    January 9, 2013
    Date of Event
    September 24, 2012
    Report Date
    January 9, 2013
    Manufacturer
    ETHICON ENDO SURGERY LLC
    Product Code
    LFL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A (B)(6) FEMALE ADMITTED FOR LAPAROSCOPIC RECTOPEXY POSTERIOR BY DR. (B)(6). PER THE EVENT REPORT, "DURING THE SURGICAL PROCEDURE, ... DR. (B)(6) NOTED THAT THE TEFLON PIECE ON THE TIP OF THE HARMONIC ACE36E WAS PEELING OFF. PRODUCT REMOVED FROM THE SURGICAL FIELD AND REPLACED." THERE WAS NO HARM TO THE PT AND THE SURGERY WAS COMPLETED WITHOUT INCIDENT. THE INSTRUMENT WAS GIVEN TO THE REFURBISHING VENDOR, STRYKER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10572 ETHICON ENDO SURGERY LLC HARMONIC ACE SURGICAL SHEARS LFL ETHICON ENDO SURGERY LLC HARMONIC ACE SHEARS 2079029

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR