BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STORZ ENDOSCOPE AUTOCON II 400 ELECTROSURGICAL GEN

    MDR report key: 6983302 · Received October 27, 2017

    Report

    Report Number
    MW5072990
    Event Type
    Malfunction
    Date Received
    October 27, 2017
    Date of Event
    October 17, 2017
    Report Date
    October 25, 2017
    Manufacturer
    KARL STORZ ENDOSCOPY - AMERICA, INC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    KARL STORZ ENDOSCOPY ESU STORZ AUTOCON II 400" MODEL 205352 20 SPARKED DURING USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    765018 STORZ ENDOSCOPE AUTOCON II 400 ELECTROSURGICAL GEN ESU ELECTROSURGICAL, CUTTING, COAGULATION & ACCESSORIES GEI KARL STORZ ENDOSCOPY - AMERICA, INC. 205352

    Patients

    Seq Age Sex Outcome Treatment
    1