BEUDAMED
    FDA Adverse Event Summary report: N

    STYKE-FLOW2

    MDR report key: 3921406 · Received July 2, 2014

    Report

    Report Number
    3921406
    Date Received
    July 2, 2014
    Date of Event
    March 14, 2014
    Report Date
    July 2, 2014
    Manufacturer
    STRYKER ENDOSCOPY DIV. OF STRYKER CORP
    Product Code
    GCX
    Report Source
    User Facility report
    Reporter Location
    IN, US

    Narratives

    Description of Event or Problem · 1

    THE SUCTION IRRIGATOR WAS LEAKING. THE DEVICE WAS VERY HOT ON THE OUTSIDE AND SIZZLING. THE DEVICE WAS REMOVED FROM THE FIELD AND TAKEN APART. THE BATTERIES WERE CORRODED. THE SMOKING FLUID HAD BACKED INTO THE IRRIGATOR AND INTO THE BATTERY COMPARTMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386322 STYKE-FLOW2 APPARATUS, SUCTION, OPERATING-ROOM GCX STRYKER ENDOSCOPY DIV. OF STRYKER CORP 250-070-500 1431FG2

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR