BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNIDRIVE GYN MORCELLATOR MOTOR SYSTEM

    MDR report key: 4990400 · Received July 31, 2015

    Report

    Report Number
    9610617-2015-00062
    Event Type
    Death
    Date Received
    July 31, 2015
    Date of Event
    October 17, 2014
    Report Date
    October 8, 2015
    Manufacturer
    KARL STORZ GMBH & CO. KG TUTTLINGEN, GERMANY
    Product Code
    GCJ
    PMA / PMN Number
    K061180
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO INDICATION OF ANY MALFUNCTION OF THE DEVICE. WE FILED (B)(4) VIA MAIL ON (B)(6) 2015 BASED ON INFORMATION FROM ATTORNEY'S OFFICE; ON (B)(6) 2015 WE RECEIVED AN MDR FROM THE HOSPITAL ITSELF THAT HAD FURTHER INFORMATION SO I FILED THE SUPPLEMENTAL VIA EMDR THAT CONTAINS THE NEW INFORMATION. I HAVE USED THE HOSPITAL'S REPORTER INFORMATION ON THIS SUPPLEMENTAL AND USED THE DATE (B)(6) 2015 AS WHEN WE REC'D THE REPORT.

    Additional Manufacturer Narrative · 1

    THERE WAS NO INDICATION OF ANY MALFUNCTION OF THE DEVICE.

    Description of Event or Problem · 1

    ALLEGEDLY, THE PATIENT WAS DIAGNOSED WITH LEIOMYOSARCOMA SHORTLY AFTER UNDERGOING A ROBOTIC ASSISTED LAPAROSCOPIC SUPRACERVICAL HYSTERECTOMY PROCEDURE IN WHICH A KARL STORZ MORCELLATOR WAS USED; PATIENT LATER EXPIRED.

    Description of Event or Problem · 1

    ALLEGEDLY, THE PT WAS DIAGNOSED WITH LEIOMYOSARCOMA SHORTLY AFTER UNDERGOING A ROBOTIC ASSISTED LAPAROSCOPIC SUPRACERVICAL HYSTERECTOMY PROCEDURE IN WHICH A KARL STORZ MORCELLATOR WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    501452 UNIDRIVE GYN MORCELLATOR MOTOR SYSTEM MORCELLATOR GCJ KARL STORZ GMBH & CO. KG TUTTLINGEN, GERMANY 26711101-1

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Death| L