BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 13657656 · Received March 3, 2022

    Report

    Report Number
    9610877-2022-51375
    Event Type
    Malfunction
    Date Received
    March 3, 2022
    Date of Event
    February 22, 2022
    Report Date
    March 3, 2022
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    FDT
    UDI-DI
    04961333233007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS DEVICE IS CLASSIFIED AS IMPORT FOR EXPORT, THEREFORE 510K IS NOT APPLICABLE. MODEL ED34-I10T2-US? IS AVAILABLE IN THE USA WITH A 510K NUMBER K192245. WE CHECKED THE RETURNED UNIT AND CONFIRMED THAT THE OPERATION CHANNEL CLOGGED. BASED ON THE RESULT, WE CONCLUDED THAT IT WAS CAUSED DUE TO THE INSUFFICIENT REPROCESSING AT THE FACILITY ON THE OPERATION CHANNEL. 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 UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. OPERATION/SUCTION CHANNEL CLOGGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1482853 PENTAX VIDEO DUODENOSCOPE FDT HOYA CORPORATION PENTAX TOKYO OFFICE ED34-I10T2 04961333233007

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown