BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERFAS ENERGY SUPER 90-S

    MDR report key: 1970333 · Received January 18, 2011

    Report

    Report Number
    2648666-2011-00013
    Event Type
    Malfunction
    Date Received
    January 18, 2011
    Date of Event
    January 5, 2011
    Report Date
    January 6, 2011
    Manufacturer
    STRYKER ENDOSCOPY PUERTO RICO
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNIT KEPT ACTIVATING IN CUT MODE AFTER THE FOOT PEDAL WAS RELEASED. IT WAS FURTHER REPORTED THAT THIS HAPPENED A COUPLE OF TIMES. THERE WERE NO REPORTS OF ANY ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SERFAS ENERGY SUPER 90-S PROBE GEI STRYKER ENDOSCOPY PUERTO RICO 10336AE2

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK