BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 12580582 · Received October 5, 2021

    Report

    Report Number
    9610877-2021-01084
    Event Type
    Malfunction
    Date Received
    October 5, 2021
    Date of Event
    September 16, 2021
    Report Date
    January 31, 2022
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    FDF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED WITH THE NEW INFORMATION. THIS DEVICE IS CLASSIFIED AS IMPORT FOR EXPORT, THEREFORE 510K IS NOT APPLICABLE. MODEL EC38-I10L-US IS AVAILABLE IN THE USA WITH A 510K NUMBER K131855.

    Additional Manufacturer Narrative · 0

    EVALUATION SUMMARY: THE DISTAL BODY REPLACED.

    Description of Event or Problem · 0

    THE ELECTRICAL SAFETY TEST FAILED. 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
    1471690 PENTAX VIDEO COLONOCOPE - I10 STANDARD FDF HOYA CORPORATION PENTAX TOKYO OFFICE EC38-I10F

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown