BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISPOSABLE ENDOSCOPE VALVES SET

    MDR report key: 10586521 · Received September 25, 2020

    Report

    Report Number
    3014749926-2020-00001
    Event Type
    Malfunction
    Date Received
    September 25, 2020
    Date of Event
    August 17, 2020
    Report Date
    September 18, 2020
    Manufacturer
    GA HEALTH COMPANY LIMITED
    Product Code
    OCX
    UDI-DI
    04897106950225
    PMA / PMN Number
    K181509
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    NO PATIENT INJURY OR SAFETY ISSUE REPORTED. THE DISASSEMBLY OF SUCTION VALVE MAY CAUSE PROLONGED PROCEDURE. IT IS DETERMINED THAT SUCH IMPACT WILL NOT BE A MAJOR ISSUE IN PROCEDURE AND THEREFORE IMMEDIATE CORRECTIVE ACTION FOR ON FIELD PRODUCT IS NOT REQUIRED. ANALYSIS HAS ESTIMATED THE PROBABILITY OF DEVICE FAILURE TO BE LOW. ON 2020-11-03 GA HEALTH COMPANY LIMITED (HEREINAFTER REFERRED TO AS "GA HEALTH") BEGAN VOLUNTARILY RECALLING SUCTION VALVE WHICH IS ALSO INCLUDED IN DISPOSABLE ENDOSCOPE VALVES SET FROM OUR CUSTOMERS AND HOSPITALS.

    Description of Event or Problem · 0

    THE SUCTION BUTTON IS REPORTED STICKY AND/OR BROKEN DURING OR AFTER THE PROCEDURE FROM THREE LOTS. THE EVENTS OCCURRED OUTSIDE THE US AND THE DEVICE IS NOT RETURNED FOR ANALYSIS. THERE IS NO PATIENT INJURY REPORTED.

    Description of Event or Problem · 1

    THE SUCTION BUTTON IS REPORTED STICKY AND/OR BROKEN DURING OR AFTER THE PROCEDURE FROM THREE LOTS. THE EVENTS OCCURRED OUTSIDE THE US AND THE DEVICE IS NOT RETURNED FOR ANALYSIS. THERE IS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1055129 DISPOSABLE ENDOSCOPE VALVES SET SUCTION VALVE OCX GA HEALTH COMPANY LIMITED GAR004 20022682, 20022627, 20021025 04897106950225

    Patients

    Seq Age Sex Outcome Treatment
    1 Other