BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNIDRIVE GYN MORCELLATOR MOTOR SYSTEM

    MDR report key: 5618443 · Received April 28, 2016

    Report

    Report Number
    9610617-2016-00075
    Event Type
    Death
    Date Received
    April 28, 2016
    Date of Event
    April 1, 2012
    Report Date
    April 19, 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. THE DEVICE WAS NOT RETURNED. WE DO NOT KNOW THE DAY OF THE EVENT; WE HAVE THE MONTH AND YEAR WHICH I ENTERED; I SELECTED (B)(6) 2012.

    Description of Event or Problem · 1

    ALLEGEDLY, ON OR ABOUT (B)(6) 2011, THE PATIENT UNDERWENT GYNECOLOGIC SURGERY WERE A POWER MORCELLATOR WAS USED. WHAT WAS THOUGHT TO BE BENIGN TISSUE WAS IN FACT UTERINE LEIOMYOSARCOMA. AFTER UNDERGOING CHEMOTHERAPY, SHE PASSED AWAY FROM COMPLICATIONS OF UTERINE LEIOMYOSARCOMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269282 UNIDRIVE GYN MORCELLATOR MOTOR SYSTEM MORCELLATOR GCJ KARL STORZ GMBH & CO. KG TUTTLINGEN, GERMANY 26711101-1

    Patients

    Seq Age Sex Outcome Treatment
    1 Death