BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GYNECARE MORCELLEX TISSUE MORCELLATOR

    MDR report key: 2110641 · Received May 20, 2011

    Report

    Report Number
    2110641
    Event Type
    Malfunction
    Date Received
    May 20, 2011
    Date of Event
    May 11, 2011
    Report Date
    May 20, 2011
    Manufacturer
    ETHICON
    Product Code
    HET
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE SURGEON STATED THAT THE UTERINE MORCELLATOR MALFUNCTIONED. HE OBTAINED ANOTHER ONE AND TOWARD THE END OF THE PROCEDURE, THE 2ND UNIT MALFUNCTIONED. HE DOES NOT KNOW WHAT HAPPENED - JUST "STOPPED MORCELLATING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GYNECARE MORCELLEX TISSUE MORCELLATOR GYNECARE MORCELLEX TISSUE MORCELLATOR HET ETHICON MX0100 MT214538
    2 GYNECARE MORCELLEX TISSUE MORCELLATOR GYNECARE MORCELLEX TISSUE MORCELLATOR HET ETHICON, INC MX0100 MT214538

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR NO OTHER THERAPIES