BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 12278851 · Received August 5, 2021

    Report

    Report Number
    9610877-2021-10119
    Event Type
    Malfunction
    Date Received
    August 5, 2021
    Date of Event
    May 21, 2021
    Report Date
    August 5, 2021
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    PEA
    UDI-DI
    04961333225262
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS CLASSIFIED AS IMPORT FOR EXPORT, THEREFORE 510K IS NOT APPLICABLE. MODEL EPK-3000US IS AVAILABLE IN THE USA WITH A 510K NUMBER K172156. EVALUATION SUMMARY: IT WAS CAUSED DUE TO A MALFUNCTION OF THE PCB FOR PROCESS AND THE DUST INSIDE. THIS REPORT IS BEING FILED AS PART OF THE PENTAX BACKLOG MANAGEMENT PLAN.

    Description of Event or Problem · 1

    THIS EVENT OCCURRED BEFORE USE. THERE WAS NO REPORT OF PATIENT HARM. CAN NOT POWER ON. A PROBLEM HAD OCCURRED 4 DAYS AFTER THE LAST REPAIR HAD BEEN COMPLETED DELIVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1181290 PENTAX VIDEO PROCESSOR (INTERNATIONAL) PEA HOYA CORPORATION PENTAX TOKYO OFFICE EPK-3000 04961333225262

    Patients

    Seq Age Sex Outcome Treatment
    1