BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE

    MDR report key: 2842173 · Received November 15, 2012

    Report

    Report Number
    3001845648-2012-00068
    Event Type
    Malfunction
    Date Received
    November 15, 2012
    Date of Event
    October 19, 2012
    Report Date
    October 20, 2012
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FCG
    PMA / PMN Number
    K934356
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL LOT NUMBER OF THE ECHO DEVICE INVOLVED IN THIS COMPLAINT WAS NOT PROVIDED. AS A CONFIRMED LOT NUMBER WAS NOT PROVIDED, IT IS NOT POSSIBLE TO ESTABLISH IF THERE WERE ANY DEVICES FROM THE AFFECTED LOT NUMBER IN STOCK AT THE TIME OF THE COMPLAINT INVESTIGATION. THE DEVICE RELATED TO THIS COMPLAINT WAS NOT AVAILABLE TO BE RETURNED FOR EVALUATION. THE COMPLAINT INFO STATED THE USE OF THE DEVICE HAD THE FOLLOWING ISSUE: "THE PHYSICIAN ATTEMPTED TO PENETRATE THE TUMOR WITH THE ECHOTIP ULTRASOUND NEEDLE BUT IT WOULD NOT GO THROUGH. THE TIP OF THE NEEDLE BROKE OFF AND A ROTH ENT WAS USED TO RETRIEVE IT." AS THE DEVICE WAS NOT RETURNED FOR EVALUATION, THE CUSTOMER COMPLAINT COULD NOT BE CONFIRMED AND THE CAUSE OF THE COMPLAINT COULD NOT BE CONCLUSIVELY DETERMINED. FROM THE INFO PROVIDED GAINING ACCESS AND PENETRATION TO THE TARGETED SITE WAS DIFFICULT. NO BIOPSY WAS OBTAINED WITH THE USE OF THIS DEVICE. PRIOR TO DISTRIBUTION, ALL ECHO-19 DEVICES ARE SUBJECTED TO FUNCTIONAL CHECKS AND VISUAL INSPECTION TO ENSURE INTEGRITY OF THE PRODUCT. A REVIEW OF THE MFG RECORDS FOR ECHO-19 DEVICES COULD NOT BE CARRIED OUT AS THE LOT NUMBER WAS NOT PROVIDED. FROM THE INFO PROVIDED, THE PT DID NOT EXPERIENCE ANY ADVERSE EFFECTS. THE TIP OF THE NEEDLE WAS SUCCESSFULLY RETRIEVED FROM THE PT. THE (B)(4) COMPLAINT HISTORY HAS BEEN REVIEWED AND THE OCCURRENCE OF THIS COMPLAINT TYPE IS LOW. NO CORRECTIVE ACTION IS WARRANTED AT THIS TIME. HOWEVER CUSTOMER QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS.

    Description of Event or Problem · 1

    THE PHYSICIAN ATTEMPTED TO PENETRATE THE TUMOR WITH THE ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE BUT IT WOULD NOT GO THROUGH. THE TIP OF THE NEEDLE BROKE OFF AND A ROTH NET WAS USED TO RETRIEVE IT. THE TIP OF THE NEEDLE WAS REMOVED FROM THE PT. IT WAS CONFIRMED THAT THE NEEDLE TIP WAS RETRIEVED AS PART OF THE ORIGINAL PROCEDURE. NO ADVERSE EFFECTS ON THE PT WERE REPORTED DUE TO THIS OCCURRENCE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1