BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERF 90-ASD PROBE

    MDR report key: 624608 · Received July 14, 2005

    Report

    Report Number
    2648666-2005-00042
    Event Type
    Malfunction
    Date Received
    July 14, 2005
    Date of Event
    August 23, 2004
    Report Date
    August 23, 2004
    Manufacturer
    STRYKER ENDOSCOPY PUERTO RICO
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SCOPE AND SERFAS WAND CREATED A SPARK, SMOKE UP THE ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SERF 90-ASD PROBE RF ABLATION PROBE GEI STRYKER ENDOSCOPY PUERTO RICO * UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN