BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCOPEVALVE BIOPSY VALVES SET OF THREE

    MDR report key: 10803292 · Received November 6, 2020

    Report

    Report Number
    3014749926-2020-00003
    Event Type
    Malfunction
    Date Received
    November 6, 2020
    Date of Event
    October 7, 2020
    Report Date
    November 5, 2020
    Manufacturer
    GA HEALTH COMPANY LIMITED
    Product Code
    OCX
    PMA / PMN Number
    K181509
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    THE SUCTION VALVE FELL APART DURING THE PROCEDURE FROM ONE LOT. THE EVENTS OCCURRED OUTSIDE THE US. THERE IS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1262675 SCOPEVALVE BIOPSY VALVES SET OF THREE DISPOSABLE ENDOSCOPE VALVES SET OCX GA HEALTH COMPANY LIMITED ENDO004 19122311

    Patients

    Seq Age Sex Outcome Treatment
    1