BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 12200843 · Received July 21, 2021

    Report

    Report Number
    9610877-2021-10247
    Event Type
    Malfunction
    Date Received
    July 21, 2021
    Date of Event
    April 27, 2021
    Report Date
    July 21, 2021
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    ODG
    UDI-DI
    04961333239597
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS CLASSIFIED AS IMPORT FOR EXPORT, THEREFORE 510K IS NOT APPLICABLE. MODEL EG36-J10UR-US IS AVAILABLE IN THE USA WITH 510K NUMBER K200090. EVALUATION SUMMARY: IT WAS CAUSED DUE TO AN EXCESSIVE FORCE APPLIED ON THE US CONNECTOR WHILE CONNECTING AND DISCONNECTING. 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 REPROCESSING. THERE WAS NO REPORT OF PATIENT HARM. EUS CONNECTOR HOLDING PLATE DETACHED. HOLDING SCREW MISSING OR LOOSEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1098295 PENTAX DIGITAL RADIAL ULTRASOUND SCOPE ODG HOYA CORPORATION PENTAX TOKYO OFFICE EG36-J10UR 04961333239597

    Patients

    Seq Age Sex Outcome Treatment
    1