BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 12423874 · Received September 3, 2021

    Report

    Report Number
    9610877-2021-00781
    Event Type
    Malfunction
    Date Received
    September 3, 2021
    Date of Event
    August 4, 2021
    Report Date
    September 3, 2021
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    FDS
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS DEVICE IS CLASSIFIED IS IMPORT FOR EXPORT AND IS NOT AVAILABLE FOR SALE IN THE UNITED STATES, THEREFORE THERE IS NO 510K APPLICABLE. THERE IS A SIMILAR MODEL AVAILABLE FOR SALE IN THE UNITED STATES EG34-I10-US WITH A 510K NUMBER OF K180292. (B)(4). IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED WITH THE NEW INFORMATION.

    Description of Event or Problem · 0

    PENTAX MEDICAL WAS MADE AWARE OF AN EVENT WHICH OCCURRED IN THE EMEA REGION INVOLVING PENTAX VIDEO SCOPE EG34-I10. IN THE EVENT REPORTED, IT WAS STATED THAT THE BENDING RUBBER WAS LEAKY. THE ANOMALY WAS OBSERVED IN THE WORKSHOP DURING INSPECTION. THERE WAS NO ADVERSE EVENT REPORTED WITH THIS COMPLAINT. THE DEVICE IS PENDING REPAIR WHERE THE DEFECTIVE PART WILL BE REPLACED. NO ADDITIONAL INFORMATION WAS PROVIDED THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1319401 PENTAX VIDEO GASTROSCOPE FDS HOYA CORPORATION PENTAX TOKYO OFFICE EG34-I10

    Patients

    Seq Age Sex Outcome Treatment
    1