BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HDVIDEO COLONOSCOPE 3.8C 13.2T 1700L FWJ

    MDR report key: 19903910 · Received August 5, 2024

    Report

    Report Number
    9610877-2024-55900
    Event Type
    Malfunction
    Date Received
    August 5, 2024
    Date of Event
    July 23, 2024
    Report Date
    August 5, 2024
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    FDF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT WAS RETURNED TO PENTAX MEDICAL FOR REPAIR. OUR TECHNICIAN CHECKED THE RETURNED UNIT AND CONFIRMED THAT THE AIR TUBE CLOGGED. BASED ON THE RESULT, WE CONCLUDED THAT IT WAS CAUSED DUE TO THE INADEQUATE/INSUFFICIENT REPROCESSING AT THE FACILITY ON THE AIR TUBE. IN ADDITION, OUR TECHNICIAN CONFIRMED THAT THE ANGLE WIRE STRETCHED, THE WATER TUBE CLOGGED, THE BENDING RUBBER GLUING MISSING, THE REMOTE CONTROL BUTTONS CUT, THE ETHYLENE OXIDE GAS VALVE (EOG) LOOSE, AND THE AIR/WATER SOCKET CHIPPED/CUT O-RING; HOWEVER, THESE DEFECTS ARE NOT THE MAIN CAUSE, AND/OR IRRELEVANT TO THE ALLEGED COMPLAINT. THIS DEFECT OCCURRED NOT DURING PROCEDURE. BASED ON THE TECHNICAL REPORT ""HR-RPT-0630(AIR/WATER & JET WATER CHANNELS)"" AND/OR THE RISK ANALYSIS RESULTS, IT WAS EVALUATED TO SUBMIT MDR.

    Description of Event or Problem · 0

    THE TIME OF EVENT IS NOT DURING PROCEDURE. THERE WAS NO REPORT OF PATIENT HARM. AIR/WATER TUBE CLOGGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1935577 HDVIDEO COLONOSCOPE 3.8C 13.2T 1700L FWJ FDF

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown