BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 15332885 · Received September 1, 2022

    Report

    Report Number
    9610877-2022-57310
    Event Type
    Malfunction
    Date Received
    September 1, 2022
    Date of Event
    August 9, 2022
    Report Date
    September 1, 2022
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    PEA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS DEVICE IS CLASSIFIED AS IMPORT FOR EXPORT, THEREFORE 510K IS NOT APPLICABLE. MODEL EPK-3000-US IS AVAILABLE IN THE USA WITH A 510K NUMBER K172156. WE CHECKED THE RETURNED UNIT AND CONFIRMED THAT THE IRIS DIAPHRAGM MALFUNCTION. BASED ON THE RESULT, WE CONCLUDED THAT IT WAS CAUSED DUE TO THE EXCESSIVE SHOCK APPLIED ON THE IRIS DIAPHRAGM. IN ADDITION, WE CONFIRMED THAT THE BATTERY WEAK, THE PRE-PROCESS PCB MALFUNCTION, AND THE XENON LAMP WORN OUT; HOWEVER, THEY ARE NOT THE MAIN CAUSE, AND/OR IRRELEVANT TO THE ALLEGED COMPLAINT. 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
    2353606 PENTAX VIDEO PROCESSOR PEA HOYA CORPORATION PENTAX TOKYO OFFICE EPK-I

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown