BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.5MM 90-S SERFAS ENERGY SUCTION PROBE

    MDR report key: 1881413 · Received October 19, 2010

    Report

    Report Number
    2648666-2010-00429
    Event Type
    Malfunction
    Date Received
    October 19, 2010
    Date of Event
    October 6, 2010
    Report Date
    October 6, 2010
    Manufacturer
    STRYKER ENDOSCOPY PUERTO RICO
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROBE UNIT WAS EXPELLING SPARKS DURING A CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3.5MM 90-S SERFAS ENERGY SUCTION PROBE ENERGY SUCTION PROBE GEI STRYKER ENDOSCOPY PUERTO RICO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK