BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 12200823 · Received July 21, 2021

    Report

    Report Number
    9610877-2021-10160
    Event Type
    Malfunction
    Date Received
    July 21, 2021
    Date of Event
    May 13, 2021
    Report Date
    July 21, 2021
    Product Code
    CAL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS CLASSIFIED AS IMPORT FOR EXPORT, THEREFORE 510K IS NOT APPLICABLE. MODEL FB-15V IS AVAILABLE IN THE USA WITH A 510K NUMBER K951199. EVALUATION SUMMARY: IT WAS CAUSED DUE TO A FLUID DAMAGE IN THE ENDOSCOPE. 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 IMAGE WAS FOGGY. DURING USE AND REPROCESSING, THE LEAKAGE WAS FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1104122 PENTAX FIBEROPTICINTUBATIONSCOPE 2.6C 5.1TP ROP CAL FI-16RBS

    Patients

    Seq Age Sex Outcome Treatment
    1