BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GYNECARE MORCELLEX TISSUE MORCELLATOR

    MDR report key: 2982167 · Received February 18, 2013

    Report

    Report Number
    2982167
    Event Type
    Malfunction
    Date Received
    February 18, 2013
    Date of Event
    June 29, 2012
    Report Date
    November 15, 2012
    Manufacturer
    ETHICON, INC.
    Product Code
    HET
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    ND, US

    Narratives

    Description of Event or Problem · 1

    MORCELLATOR DIDN'T MORCELLATE UTERUS WELL, AS IF THE BLADE WAS DULL. A SECOND MORCELLATOR WAS OPENED AND USED AND WORKED PERFECTLY.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?LAPAROSCOPIC SUPRACERVICAL HYSTERECTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    70025 GYNECARE MORCELLEX TISSUE MORCELLATOR LAPAROSCOPE, GYNECOLOGIC HET ETHICON, INC. * MT216521

    Patients

    Seq Age Sex Outcome Treatment
    1 *