BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE MORCELLATOR

    MDR report key: 2820729 · Received October 25, 2012

    Report

    Report Number
    MW5027410
    Event Type
    Injury
    Date Received
    October 25, 2012
    Date of Event
    October 25, 2012
    Report Date
    October 25, 2012
    Manufacturer
    ETHICON WOMEN'S HEALTH & UROLOGY
    Product Code
    HET
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING THE SURGICAL CASE THE MORCELLATOR HAND PIECE STOPPED WORKING. THE CONNECTIONS WERE ALL CHECKED AND CONFIRMED TO BE INTACT. THE HAND PIECE ENDED UP BEING REPLACED AND THE NEW HAND PIECE ENDED UP WORKING WITHOUT ANY FURTHER ISSUES. REASON FOR USE: DYSFUNCTIONAL UTERINE BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GYNECARE MORCELLATOR TISSUE MORCELLATOR HET ETHICON WOMEN'S HEALTH & UROLOGY MX0100 MT217068

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention