BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNIDRIVE GYN MORCELLATOR MOTOR SYSTEM

    MDR report key: 5926982 · Received September 2, 2016

    Report

    Report Number
    9610617-2016-00138
    Event Type
    Death
    Date Received
    September 2, 2016
    Date of Event
    December 11, 2013
    Report Date
    September 2, 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 UNDERWENT A PROCEDURE IN WHICH ONE OF OUR LAPAROSCOPIC POWER MORCELLATORS (LPM) WAS USED AND, ALLEGEDLY, THE PATIENT'S CONDITION WAS IMPAIRED AND SHE DIED ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    577136 UNIDRIVE GYN MORCELLATOR MOTOR SYSTEM MORCELLATOR GCJ KARL STORZ GMBH & CO. KG TUTTLINGEN, GERMANY 26711101-1

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Death