BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 12257122 · Received July 31, 2021

    Report

    Report Number
    9610877-2021-10668
    Event Type
    Malfunction
    Date Received
    July 31, 2021
    Date of Event
    January 7, 2021
    Report Date
    July 31, 2021
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    EOQ
    UDI-DI
    04961333224081
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMARY: IT WAS CAUSED DUE TO A PHYSICAL DAMAGE ON THE DISTAL END. 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. THIS REPORT IS BEING FILED AS PART OF THE PENTAX BACKLOG MANAGEMENT PLAN.

    Description of Event or Problem · 1

    ON (B)(6) 2021, THE USER FOUND THAT THE SCOPE HAD DEFECTIVE AT ITS FRONT END. THEN, THE USER STOPPED USING IT. THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1154294 PENTAX FIBEROPTICBRONCHOSCOPE 2.0C 4.8TP RO PLS EOQ HOYA CORPORATION PENTAX TOKYO OFFICE FB-15RBS 04961333224081

    Patients

    Seq Age Sex Outcome Treatment
    1