BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIDRIVE GYN MORCELLATOR MOTOR SYSTEM

    MDR report key: 5533734 · Received March 29, 2016

    Report

    Report Number
    9610617-2016-00023
    Event Type
    Injury
    Date Received
    March 29, 2016
    Date of Event
    October 13, 2014
    Report Date
    March 15, 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
    CA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO INDICATION OF ANY MALFUNCTION OF THE DEVICE. NOT RET'D FOR EVALUATION.

    Description of Event or Problem · 1

    ALLEGEDLY, ON (B)(6) 2014, THE PATIENT UNDERWENT A LAPAROSCOPIC HYSTERECTOMY FOR UTERINE FIBROID PROCEDURE WHERE THE MORCELLATOR WAS USED. THE PATHOLOGY REPORT FROM THE PROCEDURE SHOWED ENDOMETRIAL STROMAL SARCOMA. NOTE: AM FILING SUPPLEMENTAL BECAUSE I LISTED THE MFG REPORT # INCORRECTLY: LISTED 9610617-2016-21 INSTEAD OF THE TRUE # 9610617-2016-23. THIS SUPPLEMENTAL CONTAINS THE CORRECT NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    188540 UNIDRIVE GYN MORCELLATOR MOTOR SYSTEM MORCELLATOR GCJ KARL STORZ GMBH & CO. KG TUTTLINGEN, GERMANY 26711101-1

    Patients

    Seq Age Sex Outcome Treatment
    1 Other