BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 12849986 · Received November 21, 2021

    Report

    Report Number
    9610877-2021-01637
    Event Type
    Malfunction
    Date Received
    November 21, 2021
    Date of Event
    November 17, 2021
    Report Date
    April 5, 2022
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    FDT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    EVALUATION SUMMARY: THE SEGMENT HAS 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. MODEL ED34-I10T-US IS AVAILABLE IN THE USA WITH A 510K NUMBER K163614.

    Description of Event or Problem · 0

    BRAND NEW SCOPE WITH COMPRESSED SEGMENTS, BENDING SECTION DEFORMED. 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
    1747546 PENTAX VIDEO DUODENO SCOPE FDT HOYA CORPORATION PENTAX TOKYO OFFICE ED34-I10T

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown