BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 12250866 · Received July 30, 2021

    Report

    Report Number
    9610877-2021-10489
    Event Type
    Malfunction
    Date Received
    July 30, 2021
    Date of Event
    March 5, 2021
    Report Date
    July 30, 2021
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    FDS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS CLASSIFIED AS IMPORT FOR EXPORT, THEREFORE 510K IS NOT APPLICABLE. MODEL EG-2990I-US IS AVAILABLE IN THE USA WITH A 510K NUMBER K131902. EVALUATION SUMMARY: IT WAS DUE TO THE SUCTION BUTTON WORN OUT. THIS REPORT IS BEING FILED AS PART OF THE PENTAX BACKLOG MANAGEMENT PLAN.

    Description of Event or Problem · 1

    THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. THE SUCTION BUTTON DAMAGED, THE SCOPE COULD NOT BE USED NORMALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1153485 PENTAX VIDEO GASTROSCOPE VERSION-C FDS HOYA CORPORATION PENTAX TOKYO OFFICE EG-2990ZI

    Patients

    Seq Age Sex Outcome Treatment
    1