BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 19445337 · Received June 3, 2024

    Report

    Report Number
    9610877-2024-54166
    Event Type
    Malfunction
    Date Received
    June 3, 2024
    Date of Event
    May 23, 2024
    Report Date
    June 3, 2024
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    FDT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 SEGMENT FLUID DAMAGE, THE CONTROL BODY FLUID DAMAGE, THE U/D AND THE R/L PULLEY WIRES FLUID DAMAGE, THE LCB DISTAL COVER GLASS BROKEN, THE OPERATION CHANNEL (PRIMARY) BUCKLED, THE BENDING RUBBER LEAK, THE INSERTION FLEXIBLE TUBE CUT, AND THE AFT SUCTION TUBE DIRTY; 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
    660582 PENTAX VIDEO DUODENOSCOPE - I10 STANDARD FDT HOYA CORPORATION PENTAX TOKYO OFFICE ED34-I10T

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown