BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNIDRIVE GYN MORCELLATOR MOTOR SYSTEM

    MDR report key: 5540114 · Received March 31, 2016

    Report

    Report Number
    9610617-2016-00030
    Event Type
    Death
    Date Received
    March 31, 2016
    Date of Event
    October 21, 2013
    Report Date
    March 28, 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
    AL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ALLEGEDLY, THE PATIENT, WHO HAD A HISTORY OF ABNORMAL UTERINE BLEEDING AND UTERINE FIBROIDS, UNDERWENT A ROBOTICALLY ASSISTED LAPAROSCOPIC SUPRACERVICAL HYSTERECTOMY SURGERY ON (B)(6) 2013 IN WHICH A STORZ MORCELLATOR WAS USED; AFTER THE PROCEDURE SHE WAS DIAGNOSED WITH LEIOMYOSARCOMA AND SUBSEQUENTLY DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193117 UNIDRIVE GYN MORCELLATOR MOTOR SYSTEM MORCELLATOR GCJ KARL STORZ GMBH & CO. KG TUTTLINGEN, GERMANY 26711101-1

    Patients

    Seq Age Sex Outcome Treatment
    1 Death