BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 19581408 · Received June 21, 2024

    Report

    Report Number
    9610877-2024-54678
    Event Type
    Malfunction
    Date Received
    June 21, 2024
    Date of Event
    June 10, 2024
    Report Date
    June 21, 2024
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    EOB
    UDI-DI
    04961333070916
    PMA / PMN Number
    K951196
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT WAS RETURNED TO PENTAX MEDICAL FOR REPAIR. OUR TECHNICIAN CHECKED THE RETURNED UNIT AND CONFIRMED THAT THE IMAGE SHADOW IN IMAGE. BASED ON THE RESULT, WE CONCLUDED THAT IT WAS CAUSED DUE TO THE EXCESSIVE FORCE APPLIED ON THE FIBER. IN ADDITION, OUR TECHNICIAN CONFIRMED THAT THE LIGHT GUIDE CABLE COATING DAMAGE, THE INSERTION FLEXIBLE TUBE CRUSHED, THE BENDING RUBBER LEAK, THE LIGHT GUIDE CABLE LEAK, THE LG CONNECTOR LEAK, THE U/D KNOB LOOSE, THE ANGULATION UP ANGULATION DECREASE, AND THE BENDING RUBBER PIN HOLE; HOWEVER, THESE DEFECTS ARE NOT THE MAIN CAUSE, AND/OR IRRELEVANT TO THE ALLEGED COMPLAINT. BASED ON THE TECHNICAL REPORT "HR-RPT-0586(IMAGE FAILURE)" 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. VIDEO IMAGE FAILURE(SHADOW IN IMAGE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    219277 PENTAX FIBER NASO PHARYNGO LARYNGOSCOPE EOB HOYA CORPORATION PENTAX TOKYO OFFICE FNL-10RP3 04961333070916

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown