BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 18207896 · Received November 27, 2023

    Report

    Report Number
    9610877-2023-61354
    Event Type
    Malfunction
    Date Received
    November 27, 2023
    Date of Event
    November 9, 2023
    Report Date
    November 27, 2023
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    FDF
    UDI-DI
    04961333172085
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    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 EC38-I10L-US IS AVAILABLE IN THE USA WITH A 510K NUMBER K131855. THE PRODUCT WAS RETURNED TO PENTAX MEDICAL FOR REPAIR. OUR TECHNICIAN CHECKED THE RETURNED UNIT AND CONFIRMED THAT THE DISTAL END WITH CCD MODULE CUT. BASED ON THE RESULT, WE CONCLUDED THAT IT WAS CAUSED DUE TO THE EXCESSIVE FORCE APPLIED ON THE DISTAL END WITH CCD MODULE. IN ADDITION, OUR TECHNICIAN CONFIRMED THAT THE LIGHT GUIDE CABLE BUCKLED, THE REMOTE CONTROL BUTTONS DISINFECTIONS DAMAGE, THE ROOT BRACE RUBBER (LG CONNECTOR) DISINFECTIONS DAMAGE, THE ANGLE WIRE WORN OUT, THE BENDING RUBBER DISCOLORED, THE INSERTION FLEXIBLE TUBE DISCOLORED, THE ROOT BRACE RUBBER (LG CONTROL BODY) DISCOLORED, THE LG WATER SUPPLY TUBES KINK, THE LG WATER JET SUPPLY TUBES KINK, THE ANGULATION DOWN ANGULATION DECREASE, THE ANGULATION LEFT ANGULATION DECREASE, THE ANGULATION RIGHT ANGULATION DECREASE, AND THE ANGULATION UP ANGULATION DECREASE; HOWEVER, THESE DEFECTS 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 NOT DURING PROCEDURE. THERE WAS NO REPORT OF PATIENT HARM. VIDEO IMAGE FAILURE(BLACKOUT ).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1240290 PENTAX VIDEO COLONOCOPE - I10 STANDARD FDF HOYA CORPORATION PENTAX TOKYO OFFICE EC38-I10L 04961333172085

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown