BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 14234319 · Received April 28, 2022

    Report

    Report Number
    9610877-2022-53014
    Event Type
    Malfunction
    Date Received
    April 28, 2022
    Date of Event
    April 12, 2022
    Report Date
    April 28, 2022
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    FDS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 EG-1690K IS AVAILABLE IN THE USA WITH A 510K NUMBER K131902. WE CHECKED THE RETURNED UNIT AND CONFIRMED THAT THE INSERTION FLEXIBLE TUBE (IFT) SPIRAL CLOSER CONDITION. BASED ON THE RESULT, WE CONCLUDED THAT IT WAS CAUSED DUE TO THE EXCESSIVE FORCE APPLIED ON THE INSERTION FLEXIBLE TUBE (IFT). BASED ON THE TECHNICAL REPORT "HR-RPT-0628(IFT)" 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. INSERTION FLEXIBLE TUBE (IFT) HARDENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    953703 PENTAX VIDEO GASTROSCOPE FDS HOYA CORPORATION PENTAX TOKYO OFFICE EG16-K10

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown