BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 12222468 · Received July 24, 2021

    Report

    Report Number
    9610877-2021-10389
    Event Type
    Malfunction
    Date Received
    July 24, 2021
    Date of Event
    March 22, 2021
    Report Date
    July 24, 2021
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    ODG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY : IT WAS CAUSED DUE TO THE RUBBER SEAL AND THE O-RING ON THE SUCTION VALVE WORN OUT. THIS DEVICE IS CLASSIFIED AS IMPORT FOR EXPORT, THEREFORE 510K IS NOT APPLICABLE. MODEL OF-B65 IS AVAILABLE IN THE USA WITH A 510K NUMBER K023401. THIS REPORT IS BEING FILED AS PART OF THE PENTAX BACKLOG MANAGEMENT PLAN.

    Description of Event or Problem · 1

    VALVE SOMETIMES STAY FIXED IN SPITE OF THE USAGE OF SILICON OIL. THIS EVENT OCCURRED AT THE TIME OF DURING USE. THERE WAS NO REPORT OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1119445 PENTAX SUCTION/ SUCTION CHANNEL/ CONTROL VALVE FOR EG34-J10U ODG HOYA CORPORATION PENTAX TOKYO OFFICE OF-B206

    Patients

    Seq Age Sex Outcome Treatment
    1