BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 12278854 · Received August 5, 2021

    Report

    Report Number
    9610877-2021-10587
    Event Type
    Malfunction
    Date Received
    August 5, 2021
    Date of Event
    February 8, 2021
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    FDF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS NOT MARKETED IN US, THEREFORE 510K IS NOT APPLICABLE. MODEL EC38I10CL US K190805 IS AVAILABLE IN THE USA WITH A 510K NUMBER K190805. EVALUATION SUMMARY: IT WAS CAUSED DUE TO CLOGGING THE NOZZLE BY SOMETHING LIKE A PIECE OF O-RING. WE RECEIVED THE DEFECT AND CONDUCTED THE FOLLOWING INVESTIGATION AND REPAIR. OBSERVATIONS: AIR/WATER NOZZLE CLOGGED, BENDING RUBBER PERFORATED, U/D PULLEY WIRE STRETCHED, R/L PULLEY WIRE STRETCHED. REPAIR REPLACED THE AIR/WATER NOZZLE, BENDING RUBBER, U/D PULLEY WIRE, R/L PULLEY WIRE. THIS REPORT IS BEING FILED AS PART OF THE PENTAX BACKLOG MANAGEMENT PLAN.

    Description of Event or Problem · 1

    THIS EVENT OCCURRED DURING THE INSPECTION. THERE WAS NO REPORT OF PATIENT HARM. THE NOZZLE IS CLOGGED. IT SEAMS TO BE A PART O-RING

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1181292 PENTAX VIDEO COLONOCOPE - I10 STANDARD FDF HOYA CORPORATION PENTAX TOKYO OFFICE EC38-I10F2

    Patients

    Seq Age Sex Outcome Treatment
    1