BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 12531114 · Received September 26, 2021

    Report

    Report Number
    9610877-2021-00893
    Event Type
    Malfunction
    Date Received
    September 26, 2021
    Date of Event
    September 3, 2021
    Report Date
    September 26, 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 · 0

    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 EC38-I10CL-US IS AVAILABLE IN THE USA WITH A 510K NUMBER K190805. EVALUATION SUMMARY: THE CAUSE IS THAT THE AIR CONTAINING MOISTURE THAT HAS ENTERED THE OBJECTIVE LENS / LED CONDENSES DUE TO TEMPERATURE CHANGES AND CAUSES FOGGING.

    Description of Event or Problem · 0

    THIS SCOPE WAS PLANNED TO BE USED AS A PMK LOANER. BEFORE DELIVERING THE CUSTOMER AS PMK LOANER, THIS SCOPE WAS INSPECTED IN THE PMK SERVICE TEAM. BUT THE FOGGY IMAGE SYMPTOMS APPEARED. - THIS SCOPE IS NOT REPROCESSING. - THIS SCOPE IS NOT SHIPPED TO HOSPITAL. THIS SCOPE IS PACKED TO ITS ORIGINAL FORM, AND ALL ACCESSORIES ARE INTACT. THIS EVENT OCCURRED AT THE TIME OF DURING INSPECTION. THERE WAS NO REPORT OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1428659 PENTAX IMAGINA COLONOSCOPE FDF HOYA CORPORATION PENTAX TOKYO OFFICE EG29-I10C

    Patients

    Seq Age Sex Outcome Treatment
    1