BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KARL STORZ TELESCOPE

    MDR report key: 279902 · Received February 23, 2000

    Report

    Report Number
    2020550-2000-00003
    Event Type
    Malfunction
    Date Received
    February 23, 2000
    Date of Event
    January 4, 2000
    Report Date
    February 23, 2000
    Manufacturer
    KARL STORZ GMBH & CO.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A KARL STORZ RESECTOSCOPE SET ARCED DURING A "TURP" PROCEDURE. ALTHOUGH THERE WAS NO PT INJURY INVOLVED IN THIS INCIDENT, IT COULD HAVE CAUSED INJURIES TO THE PT IF THE MALFUNCTION WERE TO RECUR, THEREFORE CO DECIDED TO REPORT IT AS AN MDR. AFTER EVALUATING THE SUBJECT INSTRUMENT SET, CO FOUND THE TELESCOPE WAS SERVICED BY A NON-KARL STORZ AUTHORIZED PARTY AND RESULTED IN THE CHANGES OF SPECIFICATION, WHICH CO BELIEVES HAS CONTRIBUTED TO THE ARCING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KARL STORZ TELESCOPE TELESCOPE GCJ KARL STORZ GMBH & CO. 27005B DT

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other