BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 12278866 · Received August 5, 2021

    Report

    Report Number
    9610877-2021-10717
    Event Type
    Malfunction
    Date Received
    August 5, 2021
    Date of Event
    December 6, 2019
    Report Date
    August 5, 2021
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    EOQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS NOT MARKETED IN US, THEREFORE 510K IS NOT APPLICABLE. MODEL FB-15V IS AVAILABLE IN THE USA WITH A 510K NUMBER K951199. EVALUATION SUMMARY: IT WAS CAUSED DUE TO THE ANGLE WIRE WORN OUT AND A FLUID DAMAGE IN THE SCOPE. THIS DEVICE IS NOT DISTRIBUTED IN US SO THAT UNIQUE IDENTIFIER IS BLANK. THIS REPORT IS BEING FILED AS PART OF THE PENTAX BACKLOG MANAGEMENT PLAN.

    Description of Event or Problem · 1

    THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. THE SCOPE WAS LACK OF ANGULATION AND THE FIELD OF VISION WAS VAGUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1181544 PENTAX FIBEROPTIC BRONCHOSCOPE 2.2C 4.9TP 600L EOQ HOYA CORPORATION PENTAX TOKYO OFFICE FCN-15X

    Patients

    Seq Age Sex Outcome Treatment
    1