BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 12726202 · Received November 1, 2021

    Report

    Report Number
    9610877-2021-50206
    Event Type
    Malfunction
    Date Received
    November 1, 2021
    Date of Event
    October 19, 2021
    Report Date
    November 1, 2021
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    FDS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS DEVICE IS CLASSIFIED AS IMPORT FOR EXPORT, THEREFORE 510K IS NOT APPLICABLE. MODEL EG-1690K IS AVAILABLE IN THE USA WITH A 510K NUMBER K131902. WE CHECKED THE RETURNED UNIT AND CONFIRMED THAT THE CCD DRIVER PCB. BASED ON THE RESULT, WE CONCLUDED THAT IT WAS CAUSED DUE TO THE FLUID DAMAGE FROM THE CCD DRIVER PCB. IN ADDITION, WE CONFIRMED THAT THE ANGLE WIRE RUPTURE; HOWEVER, IT IS NOT RELATED TO THE ALLEGED COMPLAINT. BASED ON THE TECHNICAL REPORT, IT WAS EVALUATED TO SUBMIT MDR.

    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
    1630018 PENTAX VIDEO GASTROSCOPE FDS HOYA CORPORATION PENTAX TOKYO OFFICE EG16-K10

    Patients

    Seq Age Sex Outcome Treatment
    1