BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GYNECARE MORCELLEX

    MDR report key: 2982699 · Received February 22, 2013

    Report

    Report Number
    MW5029152
    Event Type
    Malfunction
    Date Received
    February 22, 2013
    Date of Event
    February 4, 2013
    Report Date
    February 22, 2013
    Manufacturer
    ETHICON WOMEN'S HEALTH & UROLOGY
    Product Code
    HET
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHILE USING MORCELLATOR THE BLADE KEPT SPINNING WHEN IT SHOULD HAVE STOPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78949 GYNECARE MORCELLEX TISSUE MORCELLATOR HET ETHICON WOMEN'S HEALTH & UROLOGY MX0100 MT217455

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other