BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRYKERFLOW II

    MDR report key: 2210986 · Received August 9, 2011

    Report

    Report Number
    2210986
    Event Type
    Malfunction
    Date Received
    August 9, 2011
    Date of Event
    August 4, 2011
    Report Date
    August 9, 2011
    Manufacturer
    STRYKER
    Product Code
    GCX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THERE WAS NO POWER AND THE DEVICE WOULD NOT PUMP IRRIGATION SOLUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRYKERFLOW II DISPOSABLE SUCTION AND IRRIGATOR GCX STRYKER * 11174FG2

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR