BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 12222413 · Received July 24, 2021

    Report

    Report Number
    9610877-2021-10152
    Event Type
    Malfunction
    Date Received
    July 24, 2021
    Date of Event
    May 17, 2021
    Report Date
    July 24, 2021
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    FDF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS NOT DISTRIBUTED IN US SO THAT UNIQUE IDENTIFIER IS BLANK. THIS DEVICE IS NOT DISTRIBUTED IN US SO THAT 510K IS BLANK. EVALUATION SUMMARY: IT WAS CAUSED DUE TO THE DUST REMAINED IN THE LENS UNIT OF ENDOSCOPE. THIS REPORT IS BEING FILED AS PART OF THE PENTAX BACKLOG MANAGEMENT PLAN.

    Description of Event or Problem · 1

    THIS EVENT OCCURRED AT THE TIME OF BEFORE USE. THERE WAS NO REPORT OF PATIENT HARM. PMK ENGINEER CONDUCTED THE FINAL INSPECTION IN PMK SERVICE CENTER BEFORE SELLING TO A DISTRIBUTOR, THE FOLLOWING SYMPTOM WAS FOUND: A DUST WAS FOUND IN UPPER CENTER OF THE IMAGE. NO LEAK. THIS SCOPE IS PACKED TO ITS ORIGINAL FORM, AND ALL ACCESSORIES ARE INTACT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1119665 PENTAX VIDEO COLONOCOPE - I10 STANDARD FDF HOYA CORPORATION PENTAX TOKYO OFFICE EC38-I10CF

    Patients

    Seq Age Sex Outcome Treatment
    1