BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRYKEFLOW II

    MDR report key: 1970640 · Received January 14, 2011

    Report

    Report Number
    1970640
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Date of Event
    December 27, 2010
    Report Date
    January 14, 2011
    Manufacturer
    STRYKER ENDOSCOPY
    Product Code
    GCX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE FLOW ADJUSTMENT KNOB FELL OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRYKEFLOW II DISPOSABLE SUCTION/IRRIGATOR GCX STRYKER ENDOSCOPY 250-070-500 10285FG2

    Patients

    Seq Age Sex Outcome Treatment
    1 *