BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 16275857 · Received February 1, 2023

    Report

    Report Number
    9610877-2023-50984
    Event Type
    Malfunction
    Date Received
    February 1, 2023
    Date of Event
    January 25, 2023
    Report Date
    February 1, 2023
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    PEA
    UDI-DI
    04961333221141
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS DEVICE IS CLASSIFIED AS IMPORT FOR EXPORT, THEREFORE 510K IS NOT APPLICABLE. MODEL EPK-I7010-US IS AVAILABLE IN THE USA WITH A 510K NUMBER K182004. WE CHECKED THE RETURNED UNIT AND CONFIRMED THAT THE IRIS DIAPHRAGM IMAGE FAILURE. BASED ON THE RESULT, WE CONCLUDED THAT IT WAS CAUSED DUE TO THE EXCESSIVE SHOCK APPLIED ON THE IRIS DIAPHRAGM. BASED ON THE TECHNICAL REPORT 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. IRIS DIAPHRAGM FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1402503 PENTAX OPTIVISTA HD VIDEO PROCESSOR (INTERNATIONAL) PEA HOYA CORPORATION PENTAX TOKYO OFFICE EPK-I7010 04961333221141

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown