BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 15975311 · Received December 14, 2022

    Report

    Report Number
    9610877-2022-61064
    Event Type
    Malfunction
    Date Received
    December 14, 2022
    Date of Event
    November 21, 2022
    Report Date
    December 14, 2022
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    EOQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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-18V IS AVAILABLE IN THE USA WITH A 510K NUMBER K951199. WE CHECKED THE RETURNED UNIT AND CONFIRMED THAT THE BIOPSY INLET PIECE LOOSENED. 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 UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. BIOPSY INLET PIECE LOOSENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    453769 PENTAX FIBEROPTICBRONCHOSCOPE 2.6C 5.9TP RO PLS EOQ HOYA CORPORATION PENTAX TOKYO OFFICE FB-18RBS

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown