BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRYKEFLOW 2

    MDR report key: 4735659 · Received March 26, 2015

    Report

    Report Number
    4735659
    Event Type
    Malfunction
    Date Received
    March 26, 2015
    Date of Event
    March 19, 2015
    Report Date
    March 26, 2015
    Manufacturer
    STRYKER ENDOSCOPY
    Product Code
    GCX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US

    Narratives

    Description of Event or Problem · 1

    THE STRYKER STRYKEFLOW SUCTION IRRIGATOR #0250-070-500 WAS IN USE DURING A LAPAROSCOPIC APPENDECTOMY CASE. TOWARDS THE END OF THE CASE, THE STRYKER UNIT WAS NOTICED TO BE LEAKING FLUID. THE FLUID ON THE PATIENT SIDE WAS CLEAR, BUT THE FLUID LEAKING WAS DISCOLORED WITH BLACK PARTICLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201739 STRYKEFLOW 2 APPARATUS, SUCTION, OPERATING-ROOM GCX STRYKER ENDOSCOPY * 105-198-185F

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR NO.