BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 13797502 · Received March 17, 2022

    Report

    Report Number
    9610877-2022-51797
    Event Type
    Malfunction
    Date Received
    March 17, 2022
    Date of Event
    February 23, 2022
    Report Date
    March 17, 2022
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    FDF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS DEVICE IS CLASSIFIED AS IMPORT FOR EXPORT, THEREFORE 510K IS NOT APPLICABLE. MODEL XXXXXXXX IS AVAILABLE IN THE USA WITH A 510K NUMBER K999999. WE CHECKED THE RETURNED UNIT AND CONFIRMED THAT THE CCD DRIVER PCB AS DEFECTIVE. BASED ON THE RESULT, WE CONCLUDED THAT IT WAS CAUSED DUE TO THE EXCESSIVE FORCE APPLIED ON THE CCD DRIVER PCB. BASED ON THE TECHNICAL REPORT AND/OR THE RISK ANALYSIS RESULTS, 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
    39033 PENTAX VIDEO COLONOSCOPE - CLASSIC LINE FDF HOYA CORPORATION PENTAX TOKYO OFFICE EC-380LKP

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown