BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 16475727 · Received March 2, 2023

    Report

    Report Number
    9610877-2023-52030
    Event Type
    Malfunction
    Date Received
    March 2, 2023
    Date of Event
    February 9, 2023
    Report Date
    March 3, 2023
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    FDF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS DEVICE IS CLASSIFIED AS IMPORT FOR EXPORT, THEREFORE 510K IS NOT APPLICABLE. MODEL FC-38LA IS AVAILABLE IN THE USA WITH A 510K NUMBER K822846. WE CHECKED THE RETURNED UNIT AND CONFIRMED THAT THE OCULAR FLUID DAMAGE. BASED ON THE RESULT, WE CONCLUDED THAT IT WAS CAUSED DUE TO THE FLUID DAMAGE FROM THE OCULAR. IN ADDITION, WE CONFIRMED THAT THE INSERTION FLEXIBLE TUBE (IFT) COMPRESSED, THE ANGLE WIRE PLAY, THE OPERATION CHANNEL LEAK, THE AIR/WATER NOZZLE DIRTY, AND THE DISTAL BODY DIRTY; HOWEVER, THEY ARE NOT THE MAIN CAUSE, AND/OR IRRELEVANT TO THE ALLEGED COMPLAINT. BASED ON THE TECHNICAL REPORT ""HR-RPT-0586 (IMAGE FAILURE)"" 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. FIBER IMAGE FAILURE (FLUID DAMAGE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1959303 PENTAX FIBER OPTIC COLONOSCOPE 3.8C 12.8T 1700 FDF HOYA CORPORATION PENTAX TOKYO OFFICE FC-38LV

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown