BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISPOSABLE ENDOSCOPE VALVES SET

    MDR report key: 10802110 · Received November 6, 2020

    Report

    Report Number
    3014749926-2020-00002
    Event Type
    Malfunction
    Date Received
    November 6, 2020
    Date of Event
    September 9, 2020
    Report Date
    November 5, 2020
    Manufacturer
    GA HEALTH COMPANY LIMITED
    Product Code
    OCX
    UDI-DI
    04897106950232
    PMA / PMN Number
    K181509
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    SUCTION VALVE REPORTED FELL APART AND DID NOT WORK FROM 2 LOTS. THE EVENTS OCCURRED OUTSIDE THE US. THERE IS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1262652 DISPOSABLE ENDOSCOPE VALVES SET SUCTION VALVE OCX GA HEALTH COMPANY LIMITED GAR004C 19122008, 20031803 04897106950232

    Patients

    Seq Age Sex Outcome Treatment
    1