BEUDAMED
    FDA Adverse Event Other Summary report: N

    KARL STORZ

    MDR report key: 1325079 · Received January 27, 2009

    Report

    Report Number
    2020550-2009-00003
    Event Type
    Other
    Date Received
    January 27, 2009
    Date of Event
    December 5, 2008
    Report Date
    January 27, 2009
    Manufacturer
    KARL STORZ GMBH & CO. KG
    Product Code
    HET
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    HOSPITAL REPORTS THAT DURING A HYSTERECTOMY PROCEDURE, IT WAS ALLEGED THAT HANDPIECE BECAME WARM AND MOTOR FROZE; ERROR MESSAGES SHOWED "OVERHEATED MOTOR" AND "JAMMED MOTOR." THE HOSPITAL DID NOT HAVE A BACKUP SYSTEM AND SWITCHED TO OPEN SURGERY TO COMPLETE. PROCEDURE WAS COMPLETED WITH NO PATIENT IMPACT REPORTED OTHER THAN BLEEDING DURING SWITCHOVER. BLEEDING WAS STOPPED AND PROCEDURE COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KARL STORZ UNIDRIVE II ELECTRIC MOTOR HET KARL STORZ GMBH & CO. KG 20711030 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other