BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 13589691 · Received February 24, 2022

    Report

    Report Number
    9610877-2022-51099
    Event Type
    Malfunction
    Date Received
    February 24, 2022
    Date of Event
    February 7, 2022
    Report Date
    February 24, 2022
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    FDT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    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. WE CHECKED THE RETURNED UNIT AND CONFIRMED THAT THE OBJECTIVE PRISM FLUID DAMAGE. BASED ON THE RESULT, WE CONCLUDED THAT IT WAS CAUSED DUE TO THE FLUID DAMAGE FROM THE OBJECTIVE PRISM. IN ADDITION, WE CONFIRMED THAT THE LCB DISTAL COVER GLASS BROKEN, THE AIR/WATER NOZZLE CLOGGED, THE SEGMENT LOOSENED, THE BENDING RUBBER WORN OUT, AND THE SEGMENT STEEL BRAID RUPTURE; 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-I10T-US IS AVAILABLE IN THE USA WITH A 510K NUMBER K163614. WE CHECKED THE RETURNED UNIT AND CONFIRMED THAT THE OBJECTIVE PRISM FLUID DAMAGE. BASED ON THE RESULT, WE CONCLUDED THAT IT WAS CAUSED DUE TO THE FLUID DAMAGE FROM THE OBJECTIVE PRISM. IN ADDITION, WE CONFIRMED THAT THE LCB DISTAL COVER GLASS BROKEN, THE AIR/WATER NOZZLE CLOGGED, THE SEGMENT LOOSENED, THE BENDING RUBBER WORN OUT, AND THE SEGMENT STEEL BRAID RUPTURE; 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(FLUID DAMAGE).

    Description of Event or Problem · 0

    THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. VIDEO IMAGE FAILURE(FLUID DAMAGE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    119968 PENTAX VIDEO DUODENOSCOPE - I10 STANDARD FDT HOYA CORPORATION PENTAX TOKYO OFFICE ED34-I10T

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown