BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 2470681 · Received February 24, 2012

    Report

    Report Number
    2518897-2012-00002
    Event Type
    Malfunction
    Date Received
    February 24, 2012
    Report Date
    February 25, 2012
    Manufacturer
    PENTAX MEDICAL COMPANY
    Product Code
    KOG
    PMA / PMN Number
    K09197
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). WHEN AN EUS NEEDLE IS ADVANCED THROUGH THE EG-3870UTK WORKING CHANNEL THE NEEDLE ENGAGES AN ELEVATOR MECHANISM WHICH GUIDES THE NEEDLE INTO ULTRASONIC AND ENDOSCOPIC IMAGE FIELDS. IF THE NEEDLE DOES NOT PROPERLY ENGAGE THE ELEVATOR AND THE OPERATOR CONTINUES TO ADVANCE THE NEEDLE W/O ULTRASONIC OR ENDOSCOPIC VISUALIZATION THERE IS A POTENTIAL FOR PT INJURY. THE INVESTIGATION IS ONGOING. RESULTS: ENDOSCOPIC ACCESSORY, NEEDLE.

    Description of Event or Problem · 1

    ON (B)(4) 2012, AN EMPLOYEE OF PENTAX (B)(4) LIFECARE VISITED HOSPITAL (B)(6). THE CUSTOMER REPORTED THAT WHEN USING THE EG-387OUTK ULTRASOUND VIDEO GASTROSCOPE WITH CERTAIN ANGULATION, THE EUS-FNA NEEDLE CAN RIP OUT OF ITS NOZZLE AND HURT PTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENTAX ULTRASOUND VIDEO GASTROSCOPE KOG PENTAX MEDICAL COMPANY EG-3870UTK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK 19G EUS-FNA NEEDLE