BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 12396117 · Received August 31, 2021

    Report

    Report Number
    9610877-2021-00611
    Event Type
    Malfunction
    Date Received
    August 31, 2021
    Date of Event
    August 3, 2021
    Report Date
    August 31, 2021
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    PEA
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS DEVICE IS CLASSIFIED AS IMPORT FOR EXPORT, THEREFORE 510K IS NOT APPLICABLE. THERE IS A SIMILAR MODEL EPK-3000-US AVAILABLE FOR SALE IN THE UNITED STATES WITH A 510K #K172156. (B)(4). IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED WITH THE NEW INFORMATION.

    Description of Event or Problem · 0

    PENTAX MEDICAL WAS MADE AWARE OF AN EVENT WHICH OCCURRED IN THE (B)(6) INVOLVING PENTAX VIDEO PROCESSOR EPK-3000. IN THE EVENT REPORTED, IT WAS STATED THAT THE WHEN THE POWER WAS TURNED ON (B)(6) 2021, THE LAMP WAS NOT LIT PROPERLY AND THE FRONT PANEL WAS COMPLETELY TURNED OFF. THE ANOMALY WAS OBSERVED IN THE OPERATING ROOM BEFORE USE. THERE WAS NO ADVERSE EVENT REPORTED WITH THIS COMPLAINT. NO ADDITIONAL INFORMATION WAS PROVIDED THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1297453 PENTAX VIDEO PROCESSOR PEA HOYA CORPORATION PENTAX TOKYO OFFICE EPK-3000

    Patients

    Seq Age Sex Outcome Treatment
    1