BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 19517191 · Received June 12, 2024

    Report

    Report Number
    9610877-2024-54457
    Event Type
    Malfunction
    Date Received
    June 12, 2024
    Date of Event
    May 28, 2024
    Report Date
    June 12, 2024
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    FDT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    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 ED34-I10T-US IS AVAILABLE IN THE USA WITH A 510K NUMBER K163614. THE PRODUCT WAS RETURNED TO PENTAX MEDICAL FOR REPAIR. OUR TECHNICIAN CHECKED THE RETURNED UNIT AND CONFIRMED THAT THE OBJECTIVE PRISM CLOUDY (NOT CLEAR VIEW). BASED ON THE RESULT, WE CONCLUDED THAT IT WAS CAUSED DUE TO THE MOISTURE CONDENSATION IN THE OBJECTIVE PRISM. IN ADDITION, OUR TECHNICIAN CONFIRMED THAT THE OPERATION CHANNEL (PRIMARY) BUCKLED, THE SUCTION CHANNEL BUCKLED, THE AIR/WATER SOCKET CHIPPED/CUT O-RING, THE BENDING RUBBER LEAK, THE INSERTION FLEXIBLE TUBE WORN OUT, THE LIGHT GUIDE CABLE WORN OUT, AND THE SEGMENT STEEL BRAID RUPTURE; 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(CLOUDY).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    373172 PENTAX VIDEO DUODENOSCOPE - I10 STANDARD FDT HOYA CORPORATION PENTAX TOKYO OFFICE ED34-I10T

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown