BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 12222399 · Received July 24, 2021

    Report

    Report Number
    9610877-2021-10102
    Event Type
    Malfunction
    Date Received
    July 24, 2021
    Date of Event
    May 26, 2021
    Report Date
    July 24, 2021
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    PEA
    UDI-DI
    04961333223794
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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. EVALUATION SUMMARY: IT WAS CAUSED DUE TO THE PERIPHERAL BOARD FAILURE. THIS REPORT IS BEING FILED AS PART OF THE PENTAX BACKLOG MANAGEMENT PLAN.

    Description of Event or Problem · 1

    THIS EVENT OCCURRED AT THE TIME OF BEFORE USE. THERE WAS NO REPORT OF PATIENT HARM. NEW PROCESSOR WITH SYSTEM LIFE OF 149H. ERROR CODE 59-06 APPEARS INDICATING: ""SLIDING MORE OF OE UNIT MAY HAVE SOMETHING BAD"". AFTER REPLACEMENT OF OE UNIT, ERROR CODE 59-06 OCCURRED AGAIN. NEXT STEP: REPLACEMENT OF PERIPHERAL PCB. AFTER REPLACEMENT OF PERIPHERAL PCB PROBLEM WITH ERROR CODE 59-06 WAS SOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1119639 PENTAX OPTIVISTA HD VIDEO PROCESSOR (INTERNATIONAL) PEA HOYA CORPORATION PENTAX TOKYO OFFICE EPK-I7010 04961333223794

    Patients

    Seq Age Sex Outcome Treatment
    1