BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNIDRIVE GYN MORCELLATOR MOTOR SYSTEM

    MDR report key: 5601706 · Received April 22, 2016

    Report

    Report Number
    9610617-2016-00044
    Event Type
    Death
    Date Received
    April 22, 2016
    Date of Event
    June 21, 2010
    Report Date
    April 14, 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
    DC, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ALLEGEDLY, ON (B)(6) 2010 THE PATIENT UNDERWENT A GYNECOLOGIC SURGERY FOR AN ENLARGING FIBROID TUMOR IN WHICH A MORCELLATOR WAS USED AND WAS FOUND TO HAVE LEIOMYOSARCOMA AFTER THE SURGERY BASED ON THE PATHOLOGICAL ANALYSIS OF THE MORCELLATED TISSUES. ON (B)(6) 2012 HER CANCER HAD SPREAD, MANIFESTING IN A PELVIC MASS AS WELL AS A PELVIC NODULE. SHE DIED ON (B)(6) 2015 FROM METASTATIC UTERINE LEIOMYOSARCOMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    257192 UNIDRIVE GYN MORCELLATOR MOTOR SYSTEM MORCELLATOR GCJ KARL STORZ GMBH & CO. KG TUTTLINGEN, GERMANY 26711101-1

    Patients

    Seq Age Sex Outcome Treatment
    1 Death