BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GYNECARE X-TRACT MORCELLATOR

    MDR report key: 1891763 · Received October 20, 2010

    Report

    Report Number
    1891763
    Event Type
    Malfunction
    Date Received
    October 20, 2010
    Date of Event
    October 5, 2010
    Report Date
    October 20, 2010
    Manufacturer
    ETHICON, INC.
    Product Code
    HET
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT, US

    Narratives

    Description of Event or Problem · 1

    THE BLADE COLLAR WAS FALLING OFF. A SECOND DEVICE WAS OBTAINED TO COMPLETE PROCEDURE.====================== HEALTH PROFESSIONAL'S IMPRESSION======================UNKNOWN====================== MANUFACTURER RESPONSE FOR GYNECARE X-TRACT MORCELLATOR, GYNECARE X-TRACT MORCELLATOR======================MANUFACTURER PROVIDED RGA# AND SHIPPING CONTAINER FOR PRODUCT RETURN EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GYNECARE X-TRACT MORCELLATOR GYNECARE X-TRACT MORCELLATOR HET ETHICON, INC. DV0015 MS0310013

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR