BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 12351821 · Received August 21, 2021

    Report

    Report Number
    9610877-2021-10153
    Event Type
    Malfunction
    Date Received
    August 21, 2021
    Date of Event
    May 14, 2021
    Report Date
    August 21, 2021
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    FDF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: AS A RESULT OF INVESTIGATING FOR THE RETURNED SCOPE, WE CONFIRMED THAT A BREAKAGE OF KAPTON TAPE WOUND AROUND CMOS UNIT INSIDE THE SCOPE DISTAL END. IT CAUSED THAT THE ELECTRICAL SAFETY TEST IN EMEA TO FAIL. MODEL EC38-I10CL US K190805 IS AVAILABLE IN THE USA WITH A 510K NUMBER K190805. THIS REPORT IS BEING FILED AS PART OF THE PENTAX BACKLOG MANAGEMENT PLAN.

    Description of Event or Problem · 1

    THERE WAS NO REPORT OF PATIENT HARM. THE USER SUBMITTED THE SCOPE TO CHECK THE AIR / WATER INSUFFLATION. DURING THE INCOMING INSPECTION PENTAX MEDICAL BULGARIA FOUND THE ELECTRICAL SAFETY TEST FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1249237 PENTAX VIDEO COLONOCOPE - I10 STANDARD FDF HOYA CORPORATION PENTAX TOKYO OFFICE EC38-I10CF2

    Patients

    Seq Age Sex Outcome Treatment
    1