BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRYKEFLOW II

    MDR report key: 1832328 · Received September 8, 2010

    Report

    Report Number
    MW5017350
    Event Type
    Malfunction
    Date Received
    September 8, 2010
    Date of Event
    August 27, 2010
    Report Date
    August 27, 2010
    Manufacturer
    STRYKER ENDOSCOPY
    Product Code
    GCX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AR, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    SUCTION/IRRIGATOR FUNCTIONED ON & OFF INDEPENDENTLY DURING LAPAROSCOPIC PROCEDURE IN OPERATING ROOM. POST-OP, DISPOSABLE DEVICE WAS DISASSEMBLED AND FOUND BURNED AREA/MELTING INSIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRYKEFLOW II DISPOSABLE SUCTION/IRRIGATOR GCX STRYKER ENDOSCOPY 10169FG2

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR