BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE

    MDR report key: 3946269 · Received July 16, 2014

    Report

    Report Number
    3001845648-2014-00132
    Event Type
    Injury
    Date Received
    July 16, 2014
    Date of Event
    June 20, 2014
    Report Date
    June 20, 2014
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FCG
    PMA / PMN Number
    K083330
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PMA/510(K) #: K083330 (K934356).

    Description of Event or Problem · 1

    DURING AN ENDOSCOPIC ULTRASONOGRAPHY (EUS) WITH A FINE NEEDLE ASPIRATION PROCEDURE, THE PHYSICIAN WAS ATTEMPTING TO PUT THE NEEDLE INTO THE BODY OF THE PANCREAS LESION. THE NEEDLE WOULD NOT PENETRATE THE WALL, THEN IT WAS NOTED THE TIP OF THE NEEDLE HAD BROKEN OFF INSIDE OF THE PATIENT. THE PHYSICIAN USED A ROTHNET TO RETRIEVE THE TIP. AN ECHO-322 WAS USED TO COMPLETE THE PROCEDURE. NO FURTHER ADVERSE EFFECTS TO THE PATIENT REPORTED AS OCCURRING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    415816 ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE FCG KIT, NEEDLE, BIOPSY FCG COOK IRELAND LTD C994935

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention