BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRYKEFLOW

    MDR report key: 9711020 · Received February 14, 2020

    Report

    Report Number
    9711020
    Event Type
    Malfunction
    Date Received
    February 14, 2020
    Date of Event
    January 16, 2020
    Report Date
    January 16, 2020
    Manufacturer
    STRYKER CORPORATION
    Product Code
    GCX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    STRYKER SUCTION IRRIGATOR STARTED LEAKING FROM THE BATTERY HOUSING. INCIDENT DISCOVERED PRIOR TO AFFECTING PATIENT AND DEVICE WAS REPLACED. PRODUCT DEFECT FORM FILLED OUT. LOT # 19234FG2. REF # 250-070-500.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175711 STRYKEFLOW APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED GCX STRYKER CORPORATION 19234FG2

    Patients

    Seq Age Sex Outcome Treatment
    1