BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNIDRIVE GYN MORCELLATOR MOTOR SYSTEM

    MDR report key: 6059070 · Received October 26, 2016

    Report

    Report Number
    9610617-2016-00151
    Event Type
    Death
    Date Received
    October 26, 2016
    Date of Event
    December 1, 2013
    Report Date
    October 26, 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

    THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY AN ATTORNEY THAT A PATIENT ALLEGEDLY UNDERWENT A PROCEDURE IN WHICH ONE OF OUR LAPAROSCOPIC POWER MORCELLATORS (LPM) WAS USED AND THE PATIENT DIED IN (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    707799 UNIDRIVE GYN MORCELLATOR MOTOR SYSTEM MORCELLATOR GCJ KARL STORZ GMBH & CO. KG TUTTLINGEN, GERMANY 26711101-1

    Patients

    Seq Age Sex Outcome Treatment
    1 Death