BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERFAS ENERGY SUPER 90-S

    MDR report key: 1963284 · Received January 6, 2011

    Report

    Report Number
    2648666-2011-00006
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Date of Event
    December 22, 2010
    Report Date
    December 23, 2010
    Manufacturer
    STRYKER ENDOSCOPY PUERTO RICO
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO WILL BE PROVIDED ONCE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ELECTRODE STARTS WORKING (ACTIVATING) WHEN THE FOOT CONTROL IS NOT PRESSED NOR THE BUTTONS PRESSED. THE FOOT CONTROL WAS SWITCHED TO ACTIVATE THE FORMULA BURRS AND IT DOES NOT SELF ACTIVATE. A NEW 90-S WAS OPENED AND HAD ISSUE. ALLEGEDLY, THIS IS THE SECOND TIME THIS HAS HAPPENED. TODAY'S INCIDENT THE ELECTRODE STARTED TO ARC A LITTLE, IT WAS STOPPED BEFORE ANY DAMAGE OR INJURY TO THE PT OCCURRED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK