BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRYKEFLOW2 WITHOUT TIP (6BX)

    MDR report key: 2033090 · Received February 28, 2011

    Report

    Report Number
    2648666-2011-00051
    Event Type
    Malfunction
    Date Received
    February 28, 2011
    Date of Event
    December 27, 2010
    Report Date
    February 4, 2011
    Manufacturer
    STRYKER ENDOSCOPY PUERTO RICO
    Product Code
    GCX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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 FLOW ADJUSTMENT KNOB FELL OFF OF THE UNIT DURING USE. THERE WERE NO REPORTS OF ANY ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRYKEFLOW2 WITHOUT TIP (6BX) SUCTION/IRRIGATION GCX STRYKER ENDOSCOPY PUERTO RICO 10285FG2

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK