BEUDAMED
    FDA Adverse Event Summary report: N

    GYNECARE MORCELLEX

    MDR report key: 2822478 · Received October 23, 2012

    Report

    Report Number
    2822478
    Date Received
    October 23, 2012
    Date of Event
    October 8, 2012
    Report Date
    October 23, 2012
    Manufacturer
    ETHICON, INC.
    Product Code
    HET
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    LAP SUPRACERVICAL HYSTERECTOMY IN PROGRESS. WE OPENED ONE DISPOSABLE MORCELLATOR AND THE BLADE BECAME DULL. WE OPENED ANOTHER AND, AFTER A FEW MINUTES IT STARTED TO NOT FUNCTION PROPERLY. DEVICE SEQUESTERED WITH THE PACKAGING IT CAME IN. WE GAVE THE SURGEON THE NON-DISPOSABLE MORCELLATOR AND SURGERY COMMENCED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GYNECARE MORCELLEX LAPAROSCOPIC, GYNECOLOGIC INSTRUMENT, MORCELLATOR HET ETHICON, INC. $$0614MT216844.S MT216844

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR NONE KNOWN