BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRYKEFLOW II

    MDR report key: 2222018 · Received August 18, 2011

    Report

    Report Number
    MW5021813
    Event Type
    Injury
    Date Received
    August 18, 2011
    Date of Event
    August 16, 2011
    Report Date
    August 18, 2011
    Manufacturer
    STRYKER ENDOSCOPY
    Product Code
    GCX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AT THE END OF A LAP-CHOLE CASE, WHILE TAKING DOWN THE SUCTION/IRRIGATOR, BROWN FLUID WAS NOTED TO BE LEAKING OUT OF THE BATTERY CASE. IT WAS NOT FLOWING BACK FROM PT SALINE IN TUBE FROM IRRIGATION TO PT WAS CLEAR. ZERO BROWN FLUID NOTED DURING SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRYKEFLOW II SUCTION/IRRIGATOR GCX STRYKER ENDOSCOPY 11187FG2

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Hospitalization| O