BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 16990059 · Received May 24, 2023

    Report

    Report Number
    9610877-2023-54247
    Event Type
    Malfunction
    Date Received
    May 24, 2023
    Date of Event
    May 4, 2023
    Report Date
    May 24, 2023
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    FDS
    UDI-DI
    04961333237586
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS DEVICE IS CLASSIFIED AS IMPORT FOR EXPORT, THEREFORE 510K IS NOT APPLICABLE. MODEL EG29-I10C-US IS AVAILABLE IN THE USA WITH A 510K NUMBER K190805. 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 LG WATER SUPPLY TUBES DEFORMED, THE LG WATER JET SUPPLY TUBES DEFORMED, THE LG AIR SUPPLY TUBES DEFORMED, THE REMOTE CONTROL BUTTON(1) LEAK, THE REMOTE CONTROL BUTTON(2) LEAK, THE BENDING RUBBER CUT, THE INSERTION FLEXIBLE TUBE TWISTED/BUCKLED UNDER AND THE ROOT BRACE; HOWEVER, THESE DEFECTS ARE NOT THE MAIN CAUSE, AND/OR IRRELEVANT TO THE ALLEGED COMPLAINT. BASED ON THE TECHNICAL REPORT 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. OPERATION/SUCTION CHANNEL CLOGGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1515893 PENTAX IMAGINA GASTROSCOPE FDS HOYA CORPORATION PENTAX TOKYO OFFICE EG29-I10C 04961333237586

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown