BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNIDRIVE GYN MORCELLATOR MOTOR SYSTEM

    MDR report key: 6909145 · Received October 2, 2017

    Report

    Report Number
    9610617-2017-00085
    Event Type
    Death
    Date Received
    October 2, 2017
    Date of Event
    January 21, 2011
    Report Date
    October 2, 2017
    Manufacturer
    KARL STORZ GMBH & CO. KG TUTTLINGEN, GERMANY
    Product Code
    GCJ
    PMA / PMN Number
    K061180
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO INDICATION OF ANY MALFUNCTION OF THE DEVICE.

    Description of Event or Problem · 1

    ALLEGEDLY, THE PATIENT UNDERWENT A LAPAROSCOPIC GYNECOLOGICAL SURGERY FOR FIBROID TUMORS ON (B)(6) 2011 IN WHICH A MORCELLATOR WAS USED AND AFTERWARD WAS DIAGNOSED WITH LEIOMYOSARCOMA. ON (B)(6) 2012, THE PATIENT WAS DIAGNOSED WITH SOFT TISSUE SARCOMA WITH PULMONARY METASTASES AND SUBSEQUENTLY PASSED AWAY ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    688246 UNIDRIVE GYN MORCELLATOR MOTOR SYSTEM MORCELLATOR GCJ KARL STORZ GMBH & CO. KG TUTTLINGEN, GERMANY 26711101-1

    Patients

    Seq Age Sex Outcome Treatment
    1 Death