BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 17304050 · Received July 12, 2023

    Report

    Report Number
    9610877-2023-56475
    Event Type
    Malfunction
    Date Received
    July 12, 2023
    Date of Event
    June 16, 2023
    Report Date
    July 12, 2023
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    FDF
    UDI-DI
    04961333172085
    PMA / PMN Number
    K131855
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT WAS RETURNED TO PENTAX MEDICAL FOR REPAIR. OUR TECHNICIAN CHECKED THE RETURNED UNIT AND CONFIRMED THAT THE OPERATION CHANNEL (PRIMARY) STUCK ACCESSORY/OBJECT. BASED ON THE RESULT, WE CONCLUDED THAT IT WAS CAUSED DUE TO THE INADEQUATE/INSUFFICIENT REPROCESSING AT THE FACILITY ON THE OPERATION CHANNEL (PRIMARY). IN ADDITION, OUR TECHNICIAN CONFIRMED THAT THE BENDING RUBBER PERFORATED, THE LG WATER SUPPLY TUBES PERFORATED, THE LG WATER JET SUPPLY TUBES PERFORATED, THE LG AIR SUPPLY TUBES PERFORATED, THE SUCTION CHANNEL DEFORMED, THE ROOT BRACE RUBBER (LG CONTROL BODY) LOOSE, THE ANGLE WIRE GRINDING, AND THE STAY COIL TOO SHORT; HOWEVER, THESE DEFECTS ARE NOT THE MAIN CAUSE, AND/OR IRRELEVANT TO THE ALLEGED COMPLAINT. BASED ON THE TECHNICAL REPORT ""HR-RPT-0588(CHANNEL)"" AND/OR THE RISK ANALYSIS RESULTS, IT WAS EVALUATED TO SUBMIT MDR.

    Description of Event or Problem · 0

    THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. OPERATION/SUCTION CHANNEL CLOGGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249624 PENTAX VIDEO COLONOCOPE - I10 STANDARD FDF HOYA CORPORATION PENTAX TOKYO OFFICE EC38-I10L 04961333172085

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown