BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEMM POINT COAGULATOR

    MDR report key: 19165 · Received January 26, 1995

    Report

    Report Number
    MW1004873
    Event Type
    Malfunction
    Date Received
    January 26, 1995
    Date of Event
    January 6, 1995
    Report Date
    January 9, 1995
    Manufacturer
    KARL STORZ ENDOSCOPY-AMERICA, INC.
    Product Code
    FEH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    UPON COMPLETION OF PELVISCOPY, BLANCHED AREA NOTED ON UTERUS. HEAT RADIATED UP SHAFT OF ENDOCOAGULATOR PROBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEMM POINT COAGULATOR ENDOCOAGULATOR FEH KARL STORZ ENDOSCOPY-AMERICA, INC. 30627PA

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Other