BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MORCELLEX

    MDR report key: 1123844 · Received August 5, 2008

    Report

    Report Number
    1123844
    Event Type
    Malfunction
    Date Received
    August 5, 2008
    Date of Event
    July 23, 2008
    Report Date
    August 5, 2008
    Manufacturer
    GYNECARE WORLDWIDE
    Product Code
    HET
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    DURING A SUPRACERVICAL HYSTERECTOMY, THE SURGEON WAS UTILIZING THE DEVICE AND IT MALFUNCTIONED. ANOTHER DEVICE WAS UTILIZED AND IT MALFUNCTIONED.A THIRD DEVICE WAS UTILIZED AND IT WORKED. THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MORCELLEX MORCELLATOR HET GYNECARE WORLDWIDE MX0100 MT211921
    2 MORCELLEX MORCELLATOR HET GYNECARE WORLDWIDE MX0110 MT211921

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR