BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 18560568 · Received January 23, 2024

    Report

    Report Number
    9610877-2024-50569
    Event Type
    Malfunction
    Date Received
    January 23, 2024
    Date of Event
    January 16, 2024
    Report Date
    January 23, 2024
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    FAJ
    UDI-DI
    04961333083664
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    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. THE PRODUCT WAS RETURNED TO PENTAX MEDICAL FOR REPAIR. OUR TECHNICIAN CHECKED THE RETURNED UNIT AND CONFIRMED THAT THE BIOPSY INLET PIECE LOOSE. BASED ON THE RESULT, WE CONCLUDED THAT IT WAS CAUSED DUE TO THE EXCESSIVE FORCE APPLIED ON THE BIOPSY INLET PIECE. BASED ON THE TECHNICAL REPORT ""HR-RPT-0620(CONTROL BODY)"" AND/OR THE RISK ANALYSIS RESULTS, IT WAS EVALUATED TO SUBMIT MDR.

    Description of Event or Problem · 0

    THE TIME OF EVENT IS NOT DURING PROCEDURE. THERE WAS NO REPORT OF PATIENT HARM. BIOPSY INLET PIECE LOOSENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    824895 PENTAX FIBEROPTICCYSTOSCOPE 2.1C 4.9TP 400L ROP FAJ HOYA CORPORATION PENTAX TOKYO OFFICE FCY-15RBS 04961333083664

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown