BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 20341575 · Received October 1, 2024

    Report

    Report Number
    9610877-2024-57195
    Event Type
    Malfunction
    Date Received
    October 1, 2024
    Date of Event
    September 23, 2024
    Report Date
    October 1, 2024
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    GCL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G4: THIS DEVICE IS CLASSIFIED AS IMPORT FOR EXPORT, THEREFORE 510K IS NOT APPLICABLE. MODEL EE-1580K IS AVAILABLE IN THE USA WITH A 510K NUMBER K961564. D4 UDI: "NOT DISTRIBUTED IN USA", BECAUSE PRODUCTS ARE NOT DISTRIBUTED IN USA PRODUCTS, BUT SIMILAR DEVICE PRODUCT ARE LISTED IN USA. THE PRODUCT WAS RETURNED TO PENTAX MEDICAL FOR REPAIR. OUR TECHNICIAN CHECKED THE RETURNED UNIT AND CONFIRMED THAT THE AIR/WATER SOCKET CLOGGED. BASED ON THE RESULT, WE CONCLUDED THAT IT WAS CAUSED DUE TO THE INADEQUATE/INSUFFICIENT REPROCESSING AT THE FACILITY ON THE AIR/WATER SOCKET. IN ADDITION, OUR TECHNICIAN CONFIRMED THAT THE OBJECTIVE LENS LEAK; HOWEVER, THIS DEFECT IS NOT THE MAIN CAUSE, AND/OR IRRELEVANT TO THE ALLEGED COMPLAINT. THIS DEFECT OCCURRED NOT DURING PROCEDURE. BASED ON THE TECHNICAL REPORT ""HR-RPT-0630(AIR/WATER & JET WATER CHANNELS)"" AND/OR THE RISK ANALYSIS RESULTS, IT WAS EVALUATED TO SUBMIT MDR.

    Description of Event or Problem · 0

    THE TIME OF EVENT IS NOT DURING PROCEDURE. THERE WAS NO REPORT OF PATIENT HARM. AIR/WATER TUBE CLOGGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1914999 PENTAX VIDEO ESOPHAGOSCOPE GCL HOYA CORPORATION PENTAX TOKYO OFFICE EE17-J10

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown