BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 12485813 · Received September 16, 2021

    Report

    Report Number
    9610877-2021-00973
    Event Type
    Malfunction
    Date Received
    September 16, 2021
    Date of Event
    August 10, 2021
    Report Date
    December 23, 2021
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    ODG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    EVALUATION SUMMARY: OP CHANNEL BUCKLED. CORRECTION INFORMATION G6: FOLLOW UP #1 H2: TYPE OF FOLLOW UP H6: CODING CHANGED BASED ON THE INVESTIGATION RESULT.

    Additional Manufacturer Narrative · 0

    IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED WITH THE NEW INFORMATION. THIS DEVICE IS CLASSIFIED AS IMPORT FOR EXPORT, THEREFORE 510K IS NOT APPLICABLE. MODEL EG34-J10U-US IS AVAILABLE IN THE USA WITH A 510K NUMBER K200090.

    Description of Event or Problem · 0

    THE NOZZLE IS CLOGGED. THIS PROBLEM WAS FOUND AT A DEMO SCOPE DURING THE (ROUTIENE) INCOMING INSPECTION IN PENTAX (B)(4). NO USER / PATIENT AFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1382899 PENTAX DIGITAL SLIM LINEAR ULTRASOUND SCOPE ODG HOYA CORPORATION PENTAX TOKYO OFFICE EG34-J10U

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Disability