BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 12645209 · Received October 18, 2021

    Report

    Report Number
    9610877-2021-50083
    Event Type
    Malfunction
    Date Received
    October 18, 2021
    Date of Event
    January 1, 2021
    Report Date
    October 18, 2021
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    FDS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS DEVICE IS CLASSIFIED AS IMPORT FOR EXPORT, THEREFORE 510K IS NOT APPLICABLE. MODEL EG-2990K IS AVAILABLE IN THE USA WITH A 510K NUMBER K131902. WE CHECKED THE RETURNED UNIT AND CONFIRMED THAT THE CCD MODULE FAILURE. BASED ON THE RESULT, WE CONCLUDED THAT IT WAS CAUSED DUE TO AN EXCESSIVE FORCE APPLIED. IN ADDITION, WE CONFIRMED THAT THE BRAND PLATE AND SERIAL NUMBER PLATE MISSING AND THE EOG VALVE LEAKY; HOWEVER, THEY ARE NOT RELATED TO THE ALLEGED COMPLAINT.

    Description of Event or Problem · 0

    THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. VIDEO IMAGE FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1544801 PENTAX VIDEO GASTROSCOPE FDS HOYA CORPORATION PENTAX TOKYO OFFICE EG-290KP

    Patients

    Seq Age Sex Outcome Treatment
    1