BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNIDRIVE GYN MORCELLATOR MOTOR SYSTEM

    MDR report key: 8384618 · Received March 2, 2019

    Report

    Report Number
    9610617-2019-00025
    Event Type
    Death
    Date Received
    March 2, 2019
    Date of Event
    May 3, 2010
    Report Date
    February 27, 2019
    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 ROBOTIC-ASSISTED LAPAROSCOPIC HYSTERECTOMY PROCEDURE AND A LAPAROSCOPIC POWER MORCELLATOR WAS USED. THE PATIENT DEVELOPED METASTATIC ENDOMETRIOID CARCINOMA AND ULTIMATELY DIED ON (B)(6) 2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    177978 UNIDRIVE GYN MORCELLATOR MOTOR SYSTEM MORCELLATOR GCJ KARL STORZ SE & CO. KG 26711101-1

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Death