BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRYKEFLOW 2

    MDR report key: 3850503 · Received May 28, 2014

    Report

    Report Number
    3850503
    Event Type
    Malfunction
    Date Received
    May 28, 2014
    Date of Event
    January 8, 2014
    Report Date
    February 27, 2014
    Manufacturer
    STRYKER ENDOSCOPY
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    THE SUCTION IRRIGATOR FAILED DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314233 STRYKEFLOW 2 APPARATUS, SUCTION, OPERATING-ROOM GEI STRYKER ENDOSCOPY 250-080-500 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *