BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 12485804 · Received September 16, 2021

    Report

    Report Number
    9610877-2021-00963
    Event Type
    Malfunction
    Date Received
    September 16, 2021
    Date of Event
    August 11, 2021
    Report Date
    January 17, 2022
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    FDT
    UDI-DI
    04961333233007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    EVALUATION SUMMARY: THE OP CHANNEL REPLACED. CORRECTION INFORMATION: G6: FOLLOW UP #1; H2: TYPE OF FOLLOW UP; H4: DEVICE MANUFACTURER DATE; H6: CODING CHANGED, BASED ON THE INVESTIGATION RESULT.

    Additional Manufacturer Narrative · 0

    IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED WITH THE NEW INFORMATION. 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.

    Description of Event or Problem · 0

    THE OP CHANNEL IS BUCKLED. THIS PROBLEM WAS FOUND AT A DEMO SCOPE DURING THE (ROUTIENE) INCOMING INSPECTION IN PENTAX (B)(4). NO USER / PATIENT AFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1382888 PENTAX VIDEO DUODENOSCOPE FDT HOYA CORPORATION PENTAX TOKYO OFFICE ED34-I10T2 04961333233007

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown