BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 18481288 · Received January 10, 2024

    Report

    Report Number
    9610877-2024-50101
    Event Type
    Malfunction
    Date Received
    January 10, 2024
    Date of Event
    January 2, 2024
    Report Date
    January 10, 2024
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    FDT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS DEVICE IS CLASSIFIED AS IMPORT FOR EXPORT, THEREFORE 510K IS NOT APPLICABLE. MODEL ED32-I10-US IS AVAILABLE IN THE USA WITH A 510K NUMBER K202365. THE PRODUCT WAS RETURNED TO PENTAX MEDICAL FOR REPAIR. OUR TECHNICIAN CHECKED THE RETURNED UNIT AND CONFIRMED THAT THE OPERATION CHANNEL (PRIMARY) BLOCKED. BASED ON THE RESULT, WE CONCLUDED THAT IT WAS CAUSED DUE TO THE INADEQUATE/INSUFFICIENT REPROCESSING AT THE FACILITY ON THE OPERATION CHANNEL. 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
    598540 PENTAX SLIM DEC VIDEO DUODENOSCOPE FDT HOYA CORPORATION PENTAX TOKYO OFFICE ED32-I10

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown