BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 16433332 · Received February 23, 2023

    Report

    Report Number
    9610877-2023-51711
    Event Type
    Malfunction
    Date Received
    February 23, 2023
    Date of Event
    February 7, 2023
    Report Date
    February 24, 2023
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    EOQ
    UDI-DI
    04961333245802
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 EB15-J10 IS AVAILABLE IN THE USA WITH A 510K NUMBER K200678. WE CHECKED THE RETURNED UNIT AND CONFIRMED THAT THE BIOPSY INLET T-PIECE BROKEN ACCESSORY BLOCKING INSIDE BIOPSY T-PIECE. BASED ON THE RESULT, WE CONCLUDED THAT IT WAS CAUSED DUE TO THE INSUFFICIENT REPROCESSING AT THE FACILITY ON THE BIOPSY INLET T-PIECE. IN ADDITION, WE CONFIRMED THAT THE INSERTION FLEXIBLE TUBE (IFT) DENTED; HOWEVER, IT IS NOT THE MAIN CAUSE, AND/OR IRRELEVANT TO THE ALLEGED COMPLAINT. BASED ON THE TECHNICAL REPORT "HR-RPT-0588 (CHANNEL)" 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. OPERATION/SUCTION CHANNEL CLOGGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2023627 PENTAX VIDEO BRONCHOSCOPE EOQ HOYA CORPORATION PENTAX TOKYO OFFICE EB11-J10 04961333245802

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown