BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GYNECARE MORCELLEX SIGMA TISSUE MORCELLATOR

    MDR report key: 3954561 · Received July 22, 2014

    Report

    Report Number
    3954561
    Event Type
    Malfunction
    Date Received
    July 22, 2014
    Date of Event
    June 27, 2014
    Report Date
    July 22, 2014
    Manufacturer
    ETHICON, INC.
    Product Code
    HET
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US

    Narratives

    Description of Event or Problem · 1

    DEVICE BECAME JAMMED DURING CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429283 GYNECARE MORCELLEX SIGMA TISSUE MORCELLATOR LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES) HET ETHICON, INC. * MT218765

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR NO OTHER THERAPIES