BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHOTIP PROCORE HIGH DEFINITATION ULTRASOUND BIOPSY NEEDLE

    MDR report key: 4440417 · Received January 19, 2015

    Report

    Report Number
    3001845648-2015-00010
    Event Type
    Injury
    Date Received
    January 19, 2015
    Date of Event
    December 18, 2014
    Report Date
    December 22, 2014
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FCG
    PMA / PMN Number
    K083330
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. WITH THE INFO PROVIDED, A DOCUMENT BASED INVESTIGATION WAS CARRIED OUT. A REVIEW OF THE MANUFACTURING RECORDS FOR ECHO DEVICES OF LOT #C991293 DID NOT REVEAL ANY DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. THE CUSTOMER COMPLAINT IS CONSIDERED CONFIRMED BASED ON THE CUSTOMER TESTIMONY. A POSSIBLE CAUSE OF THIS COMPLAINT IS THAT THE NEEDLE TIP BENT DURING USE RESULTING IN NEEDLE BREAKAGE. THE ISSUE OCCURED ON THE THIRD PASS; THEREFORE, THE DEVICE WAS MOST LIKELY DAMAGED DURING THE PREVIOUS PASS. THE NEEDLE CAN KINK/BEND DUE TO PRODUCT HANDLING DURING THE PROCEDURE. A NEEDLE KINK/BEND MAY ALSO BE ATTRIBUTED TO PT ANATOMY IF THE LESION BEING PUNCTURED WAS A HARD LESION OR IF THE ENDOSCOPE WAS USED IN A TORTUOUS ANATOMY. AS THE NEEDLE IS ADVANCED/RETRACTED DURING THE PROCEDURE IT IS POSSIBLE THAT THE KINK/BEND RESULTED IN A BREAKAGE. PRIOR TO DISTRIBUTION, ALL ECHO-HD-19-C DEVICES ARE SUBJECTED TO FUNCTIONAL CHECKS AND VISUAL INSPECTION TO ENSURE INTEGRITY OF THE PRODUCT. THE INSTRUCTIONS FOR USE THAT ACCOMPANIES THIS DEVICE ADVISED THE USER TO INSPECT THE DEVICE PRIOR TO USE FOR ANY DAMAGE: "VISUALLY INSPECT WITH PARTICULAR ATTENTION TO KINKS, BENDS, AND BREAKS. IF AN ABNORMALITY IS DETECTED THAT WOULD PROHIBIT PROPER WORKING CONDITION, DO NOT USE." NO FURTHER ADVERSE EFFECTS HAVE BEEN REPORTED. IT IS NOT KNOWN IF THE NEEDLE TIP WAS SUCCESSFULLY RETRIEVED FROM THE PT. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 1

    WHILE PERFORMING EUS BIOPSY OF TUMOR, THE NEEDLE BROKE OFF INSIDE THE PT DURING THE THIRD PASS. AFTER IT WAS DETERMINED THAT THE TIP OF NEEDLE BROKE OFF IN THE PT, THE PHYSICIAN CONTINUED TO PERFORM FOUR MORE PASSES WITH ANOTHER COOK NEEDLE. THE NEEDLE TIP WAS NOT RETRIEVABLE. THE PT WAS REFERRED TO SURGERY FOR AN ADDITIONAL PROCEDURE TO ADDRESS THE TUMOR ITSELF AND ALSO TO REMOVE THE BROKEN NEEDLE TIP. ADDITIONAL INFO RECEIVED STATES THAT THE PT WOULD HAVE HAD TO GO TO SURGERY FOR THE TUMOR EVEN IF THE NEEDLE HAD NOT BROKEN INSIDE THE PT. FURTHER INFO IN RELATION TO THE ADDITIONAL PROCEDURE, NEEDLE RETRIEVAL AND PT OUTCOME HAS BEEN REQUESTED BUT HAS NOT BEEN RECEIVED TO DATE YET. IT IS NOT KNOWN IF THE NEEDLE TIP WAS SUCCESSFULLY RETRIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    43449 ECHOTIP PROCORE HIGH DEFINITATION ULTRASOUND BIOPSY NEEDLE KIT, NEEDLE, BIOPSY FCG COOK IRELAND LTD C991293

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention