BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRYKEFLOW II SUCTION/IRRIGATOR

    MDR report key: 1317515 · Received February 13, 2009

    Report

    Report Number
    MW5009992
    Event Type
    Malfunction
    Date Received
    February 13, 2009
    Date of Event
    February 5, 2009
    Report Date
    February 13, 2009
    Manufacturer
    STRYKER INSTRUMENTS
    Product Code
    HRX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    STRYKEFLOW II SUCTION/IRRIGATOR CATALOG # 250-070-500, LOT# 08359FG2. DURING SURGICAL PROCEDURE, DARK FLUID BEGAN TO DRIP DARK FLUID, THEN SPRAYED DARK FLUID ON TECH'S CHIN AND CHEST. DEVICE WAS SEQUESTERED AND EXAMINED AND THE LOWER CUP AND BATTERY HOUSING WAS FULL OF BROWN FLUID. SOME BATTERY CONTACTS APPEAR CORRODED. THIS WAS A SINGLE USE ITEM JUST REMOVED FROM A SEALED PACKAGE. THE SOURCE OF THE FLUID COULD NOT BE DETERMINED. DATES OF USE: SINGLE USE: 2009. DIAGNOSIS OR REASON FOR USE: LAPAROSCOPIC CHOLECYSTECTOMY. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED? YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRYKEFLOW II SUCTION/IRRIGATOR STRYKEFLOW II SUCTION/IRRIGATOR HRX STRYKER INSTRUMENTS STRYKEFLOW II 08359FG2

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR