BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 13575135 · Received February 22, 2022

    Report

    Report Number
    9610877-2022-51046
    Event Type
    Malfunction
    Date Received
    February 22, 2022
    Date of Event
    February 8, 2022
    Report Date
    February 22, 2022
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    FDT
    UDI-DI
    04961333233007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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-I10T2-US  IS AVAILABLE IN THE USA WITH A 510K NUMBER K192245. WE CHECKED THE RETURNED UNIT AND CONFIRMED THAT THE OBJECTIVE PRISM WAS BROKEN. BASED ON THE RESULT, WE CONCLUDED THAT IT WAS CAUSED DUE TO THE EXCESSIVE FORCE APPLIED ON THE OBJECTIVE PRISM. IN ADDITION, WE CONFIRMED THAT THE OPERATION CHANNEL BUCKLED, THE BENDING RUBBER LEAKY, AND THE DEFLECTOR OPERATING KNOB BROKEN; HOWEVER, THEY ARE NOT THE MAIN CAUSE, AND/OR IRRELEVANT TO THE ALLEGED COMPLAINT. BASED ON THE TECHNICAL REPORT AND/OR THE RISK ANALYSIS RESULTS, IT WAS EVALUATED TO SUBMIT MDR.

    Additional Manufacturer Narrative · 0

    THIS DEVICE IS CLASSIFIED AS IMPORT FOR EXPORT, THEREFORE 510K IS NOT APPLICABLE. MODEL ED34-I10T2-US  IS AVAILABLE IN THE USA WITH A 510K NUMBER K192245. WE CHECKED THE RETURNED UNIT AND CONFIRMED THAT THE OBJECTIVE PRISM WAS BROKEN. BASED ON THE RESULT, WE CONCLUDED THAT IT WAS CAUSED DUE TO THE EXCESSIVE FORCE APPLIED ON THE OBJECTIVE PRISM. IN ADDITION, WE CONFIRMED THAT THE OPERATION CHANNEL BUCKLED, THE BENDING RUBBER LEAKY, AND THE DEFLECTOR OPERATING KNOB BROKEN; HOWEVER, THEY ARE NOT THE MAIN CAUSE, AND/OR IRRELEVANT TO THE ALLEGED COMPLAINT. 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(OBJECTIVE LENS BROKEN)

    Description of Event or Problem · 0

    THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. VIDEO IMAGE FAILURE(OBJECTIVE LENS BROKEN).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1146774 PENTAX VIDEO DUODENOSCOPE FDT HOYA CORPORATION PENTAX TOKYO OFFICE ED34-I10T2 04961333233007

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown