BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 12178902 · Received July 16, 2021

    Report

    Report Number
    9610877-2021-10098
    Event Type
    Malfunction
    Date Received
    July 16, 2021
    Date of Event
    May 26, 2021
    Report Date
    July 16, 2021
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    EOQ
    UDI-DI
    04961333227655
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE DEFECT WAS RETURNED. WE CONFIRMED THAT THE ALLEGED SYMPTOM FROM THE COMPLAINT DESCRIPTION AND THE BODY COVER GRIP LEAK FROM OUR INVESTIGATION OF THE RETURNED DEFECT. THIS DEVICE IS CLASSIFIED AS IMPORT FOR EXPORT, THEREFORE 510K IS NOT APPLICABLE. MODEL FB-18V IS AVAILABLE IN THE USA WITH A 510K NUMBER K951199. THIS REPORT IS BEING FILED AS PART OF THE PENTAX BACKLOG MANAGEMENT PLAN.

    Description of Event or Problem · 1

    THIS EVENT OCCURRED AT THE TIME OF REPROCESSING. THERE WAS NO REPORT OF PATIENT HARM. OPERATION CHANNEL BUCKLED AT 60 CM, LEAKY. SOLD DATE 2020-02-27, LAST MAJOR REPAIR 2020-07-31.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1078729 PENTAX FIBEROPTIC BRONCHOSCOPE 3.2C 6.2TP 600L EOQ HOYA CORPORATION PENTAX TOKYO OFFICE FB-19TV 04961333227655

    Patients

    Seq Age Sex Outcome Treatment
    1