BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNIDRIVE GYN MORCELLATOR MOTOR SYSTEM

    MDR report key: 5777387 · Received July 7, 2016

    Report

    Report Number
    9610617-2016-00101
    Event Type
    Death
    Date Received
    July 7, 2016
    Date of Event
    August 23, 2012
    Report Date
    July 1, 2016
    Manufacturer
    KARL STORZ GMBH & CO. KG TUTTLINGEN, GERMANY
    Product Code
    GCJ
    PMA / PMN Number
    K061180
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO INDICATION OF ANY MALFUNCTION OF THE DEVICE. THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 1

    ALLEGEDLY, THE PATIENT UNDERWENT A LAPAROSCOPIC HYSTERECTOMY FOR THE TREATMENT OF UTERINE FIBROIDS AND WAS DIAGNOSED WITH EPITHELIOID LEIOMYOSARCOMA SHORTLY AFTER HER SURGERY, BASED ON THE PATHOLOGICAL ANALYSIS OF THE MORCELLATED UTERINE TISSUES ON (B)(6) 2012. SHE DIED ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429244 UNIDRIVE GYN MORCELLATOR MOTOR SYSTEM MORCELLATOR GCJ KARL STORZ GMBH & CO. KG TUTTLINGEN, GERMANY 26711101-1

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Death