BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 12222449 · Received July 24, 2021

    Report

    Report Number
    9610877-2021-10296
    Event Type
    Malfunction
    Date Received
    July 24, 2021
    Date of Event
    April 10, 2021
    Report Date
    July 24, 2021
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    EOB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SERIAL NUMBER IS UNAVAILABLE. THIS DEVICE IS NOT DISTRIBUTED IN US SO THAT UNIQUE IDENTIFIER IS BLANK. THIS DEVICE IS CLASSIFIED AS IMPORT FOR EXPORT, THEREFORE 510K IS NOT APPLICABLE. MODEL VNL-1570STK IS AVAILABLE IN THE USA WITH A 510K NUMBER K162151. EVALUATION SUMMARY IT WAS CAUSED DUE TO A CONDENSATION OF MOISTURE IN THE CCD UNIT BY CHANGING THE TEMPERATURE OUTSIDE OF THE 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 DURING USE. THERE WAS NO REPORT OF PATIENT HARM. DURING USE THE FOGGY IMAGE APPEARED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1119743 PENTAX VIDEO NASO PHARYNGO LARYNGOSTROBOSCOPE EOB HOYA CORPORATION PENTAX TOKYO OFFICE VNL-1070STK

    Patients

    Seq Age Sex Outcome Treatment
    1