BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 19534968 · Received June 14, 2024

    Report

    Report Number
    9610877-2024-54537
    Event Type
    Malfunction
    Date Received
    June 14, 2024
    Date of Event
    June 11, 2024
    Report Date
    June 14, 2024
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    PEA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    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 EPK-I8020C-US IS AVAILABLE IN THE USA WITH A 510K NUMBER K231249. THE PRODUCT WAS RETURNED TO PENTAX MEDICAL FOR REPAIR. OUR TECHNICIAN CHECKED THE RETURNED UNIT AND CONFIRMED THAT THE IMAGE NOISE. BASED ON THE RESULT, WE CONCLUDED THAT IT WAS CAUSED DUE TO THE EXCESSIVE SHOCK APPLIED ON THE IMAGE PROCESS DEVICE. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136846 PENTAX INSPIRA DUO EPK-I8020C PROCESSOR PEA HOYA CORPORATION PENTAX TOKYO OFFICE EPK-I8020C

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown