BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNIDRIVE GYN MORCELLATOR MOTOR SYSTEM

    MDR report key: 7780709 · Received August 14, 2018

    Report

    Report Number
    9610617-2018-00055
    Event Type
    Death
    Date Received
    August 14, 2018
    Date of Event
    January 13, 2012
    Report Date
    June 15, 2018
    Manufacturer
    KARL STORZ SE & CO. KG
    Product Code
    GCJ
    PMA / PMN Number
    K061180
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO INDICATION OF ANY MALFUNCTION OF THE DEVICE.

    Description of Event or Problem · 1

    ALLEGEDLY, THE PATIENT UNDERWENT A SUPRACERVICAL LAPAROSCOPIC HYSTERECTOMY PROCEDURE ON (B)(6) 2012 IN WHICH A MORCELLATOR WAS USED. THE PATIENT SUBSEQUENTLY DEVELOPED LEIYOMYOSARCOMA AND LATER PASSED AWAY ON (B)(6) 2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621418 UNIDRIVE GYN MORCELLATOR MOTOR SYSTEM MORCELLATOR GCJ KARL STORZ SE & CO. KG 26711101-1

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Death