BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 12889123 · Received November 30, 2021

    Report

    Report Number
    9610877-2021-50583
    Event Type
    Malfunction
    Date Received
    November 30, 2021
    Date of Event
    November 16, 2021
    Report Date
    November 30, 2021
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    FGB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS DEVICE IS CLASSIFIED AS IMPORT FOR EXPORT, THEREFORE 510K IS NOT APPLICABLE. MODEL FB-15V IS AVAILABLE IN THE USA WITH A 510K NUMBER K951199. WE CHECKED THE RETURNED UNIT AND CONFIRMED THAT THE CFB IMAGE FAILURE. BASED ON THE RESULT, WE CONCLUDED THAT IT WAS CAUSED DUE TO THE EXCESSIVE FORCE APPLIED ON THE CFB. BASED ON THE TECHNICAL REPORT AND/OR THE RISK ANALYSIS RESULTS, IT WAS EVALUATED TO SUBMIT MDR.

    Description of Event or Problem · 0

    THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. FIBER IMAGE FAILURE(BROKEN).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1799331 PENTAX FIBEROPTICURETEROSCOPE1.2C 3.0TP 700 ROP FGB HOYA CORPORATION PENTAX TOKYO OFFICE FUR-9RBS

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown