BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE

    MDR report key: 6168956 · Received December 13, 2016

    Report

    Report Number
    3001845648-2016-00359
    Event Type
    Injury
    Date Received
    December 13, 2016
    Date of Event
    November 16, 2016
    Report Date
    January 6, 2017
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FCG
    Report Source
    Manufacturer report
    Reporter Location
    KR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PMA/510(K) # K142688. ON EVALUATION OF THE RETURNED DEVICE, IT WAS NOTED THAT THE NEEDLE WAS BROKEN APPROXIMATELY 3.5CM FROM THE TIP. THE SYRINGE WAS RETURNED WITH THE NEEDLE. THE STYLET WAS PARTIALLY OUT. THE TIP OF THE NEEDLE WAS FINE AND THE REMAINING PART OF THE NEEDLE COULD BE ADVANCED AND RETRACTED. THE CUSTOMER COMPLAINT WAS CONFIRMED AS THE NEEDLE WAS BROKEN. PRIOR TO DISTRIBUTION, ALL ECHO-HD-3-20-C DEVICES ARE SUBJECTED TO FUNCTIONAL CHECKS AND VISUAL INSPECTION TO ENSURE DEVICE INTEGRITY. THESE INSPECTIONS AND FUNCTIONAL CHECKS ARE OUTLINED IN INTERNAL PROCEDURES IN PLACE AT CIRL. FROM THE INFORMATION PROVIDED, THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT AS A RESULT OF THIS OCCURRENCE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Additional Manufacturer Narrative · 1

    PMA/510(K) # K142688. THE COMPLAINT DEVICE IS AWAITING RETURN TO CIRL FOR EVALUATION. ON RETURN OF THE DEVICE A LAB EVALUATION WILL BE CARRIED OUT AND THE INVESTIGATION UPDATED. THE CUSTOMER COMPLAINT IS CONSIDERED CONFIRMED BASED ON THE CUSTOMER TESTIMONY. HOWEVER, AS THE DEVICE IS AWAITING RETURN FOR EVALUATION AND THE CONDITIONS OF DEVICE USAGE CANNOT BE REPLICATED IN THE LABORATORY IT IS THEREFORE NOT POSSIBLE TO CONCLUSIVELY DETERMINE THE ROOT CAUSE OF THIS COMPLAINT. WITH THE INFORMATION PROVIDED, A DOCUMENT BASED INVESTIGATION WAS CARRIED OUT. AS THE LOT NUMBER WAS NOT PROVIDED, A REVIEW OF MANUFACTURING INSTRUCTIONS COULD NOT BE COMPLETE. PRIOR TO DISTRIBUTION, ALL ECHO-HD-3-20-C DEVICES ARE SUBJECTED TO FUNCTIONAL CHECKS AND VISUAL INSPECTION TO ENSURE DEVICE INTEGRITY. THESE INSPECTIONS AND FUNCTIONAL CHECKS ARE OUTLINED IN INTERNAL PROCEDURES IN PLACE AT CIRL. FROM THE INFORMATION PROVIDED, THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT AS A RESULT OF THIS OCCURRENCE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 1

    THIS FOLLOW UP IS BEING SUBMITTED DUE TO RECEIPT AND EVALUATION OF THE DEVICE. THE NEEDLE WAS BROKEN DURING THE PROCEDURE. THE PHYSICIAN USED THE SCOPE ELEVATOR AND THAT IS THE REASON WHY THE PHYSICIAN THINKS THE NEEDLE WAS BROKEN. FORTUNATELY, THE DOCTOR WAS ABLE TO SEE THE BROKEN NEEDLE SO IT COULD BE REMOVED. THE DOCTOR WAS ABLE TO FINISH THE PROCEDURE USING ANOTHER PRODUCT (ECHO-HD-3-20C).

    Description of Event or Problem · 1

    THE NEEDLE WAS BROKEN DURING THE PROCEDURE. THE PHYSICIAN USED THE SCOPE ELEVATOR AND THAT IS THE REASON WHY THE PHYSICIAN THINKS THE NEEDLE WAS BROKEN. FORTUNATELY, THE DOCTOR WAS ABLE TO SEE THE BROKEN NEEDLE SO IT COULD BE REMOVED. THE DOCTOR WAS ABLE TO FINISH THE PROCEDURE USING ANOTHER PRODUCT (ECHO-HD-3-20C).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    822107 ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE FCG KIT, NEEDLE, BIOPSY FCG COOK IRELAND LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention