BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 15664824 · Received October 25, 2022

    Report

    Report Number
    9610877-2022-00580
    Event Type
    Malfunction
    Date Received
    October 25, 2022
    Date of Event
    September 28, 2022
    Report Date
    December 25, 2022
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    FDT
    PMA / PMN Number
    K163614
    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-I10T2 IS AVAILABLE IN THE USA WITH A 510K NUMBER K192245. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED WITH THE NEW INFORMATION.

    Additional Manufacturer Narrative · 0

    EVALUATION SUMMARY: IN THIS CASE, A PLASTIC STENT WAS STUCK IN THE DUCT, BLOCKING THE DUCT FROM THE CONFLUENCE OF THE FORCEPS BASE TO THE OPERATION CHANNEL.

    Description of Event or Problem · 0

    ACCESSORY/OBJECT STUCK IN THE OPERATION CHANNEL. IFT COLLAPSED. THIS EVENT OCCURRED AT THE TIME OF DURING INSPECTION. THERE WAS NO REPORT OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2352254 PENTAX VIDEO DUODENOSCOPE - I10 STANDARD FDT HOYA CORPORATION PENTAX TOKYO OFFICE ED34-I10T

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown