BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GYNECARE MORCELLEX

    MDR report key: 1061165 · Received May 30, 2008

    Report

    Report Number
    1061165
    Event Type
    Malfunction
    Date Received
    May 30, 2008
    Date of Event
    May 20, 2008
    Report Date
    May 30, 2008
    Manufacturer
    GYNECARE WORLDWIDE
    Product Code
    HET
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US

    Narratives

    Description of Event or Problem · 1

    DURING A LAPAROSCOPIC SUPRACERVICAL HYSTERECTOMY, THE MORCELLATOR DID NOT WORK AS INTENDED. EVIDENTLY IT IS SUPPOSED TO WORK AT A QUICK, EVEN SPEED AND ALTHOUGH IT DID ACCOMPLISH THE JOB, IT DID IT IN SMALL INTERMITTENT "PULSES." PHYSICIAN DID NOT WANT TO SWITCH OUT HAND PIECE (THIS DISPOSABLE HAND PIECE PLUGS INTO A BIOMED MAINTAINED GENERATOR). OR STAFF STATE THE GENERATOR PORTION WAS RETURNED TO BIOMED, PASSED ALL ITS TESTS AND WAS RETURNED TO SERVICE WHERE IT WAS USED WITHIN THE WEEK AND NO ISSUES WERE ENCOUNTERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GYNECARE MORCELLEX MORCELLATOR HET GYNECARE WORLDWIDE MX0100 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *