BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 12222504 · Received July 24, 2021

    Report

    Report Number
    9610877-2021-10302
    Event Type
    Malfunction
    Date Received
    July 24, 2021
    Date of Event
    April 9, 2021
    Report Date
    July 24, 2021
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    FDF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: IT WAS CAUSED DUE TO AN EXCESSIVE FORCE APPLIED ON THE CCD CABLE. MODEL EC38-I10L-US IS AVAILABLE IN THE USA WITH A 510K NUMBER K131855. THIS REPORT IS BEING FILED AS PART OF THE PENTAX BACKLOG MANAGEMENT PLAN.

    Description of Event or Problem · 1

    THE INSTRUMENT PRESENTS THE VANISHING IMAGE AND THE PROBE HAS NO TRAUMA. THIS EVENT OCCURRED AT THE TIME OF BEFORE USE. THERE WAS NO REPORT OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1119512 PENTAX VIDEO COLONOCOPE FDF HOYA CORPORATION PENTAX TOKYO OFFICE EC38-I10F

    Patients

    Seq Age Sex Outcome Treatment
    1