BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERFAS ENERGY SUPER 90-S

    MDR report key: 1903206 · Received November 12, 2010

    Report

    Report Number
    2648666-2010-00452
    Event Type
    Malfunction
    Date Received
    November 12, 2010
    Date of Event
    October 29, 2010
    Report Date
    October 29, 2010
    Manufacturer
    STRYKER ENDOSCOPY PUERTO RICO
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO WILL BE PROVIDED ONCE THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 5 MINUTES INTO A PROCEDURE, THE SUCTION ON THE UNIT GOT CLOGGED AND DID NOT FUNCTION. ANOTHER UNIT WAS USED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. IT WAS FURTHER REPORTED THAT THERE WERE NO 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 10251AE2

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK