BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 12973893 · Received December 10, 2021

    Report

    Report Number
    9610877-2021-01753
    Event Type
    Malfunction
    Date Received
    December 10, 2021
    Date of Event
    November 26, 2021
    Report Date
    April 5, 2022
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    FDT
    UDI-DI
    04961333233007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    EVALUATION SUMMARY: THE DEFECT PARTS HAVE BEEN REPLACED. CORRECTION INFORMATION: 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

    DEC IS REMOVED TOO EASY, TESTED WITH NEW AND OLD. DISTAL BODY WORN OUT. THIS EVENT OCCURRED AT THE TIME OF DURING INSPECTION. THERE WAS NO REPORT OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1878843 PENTAX VIDEO DUODENO SCOPE FDT HOYA CORPORATION PENTAX TOKYO OFFICE ED34-I10T2 04961333233007

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown