BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHOTIP ULTRA ENDOBRONCHIAL ULTRASOUND NEEDLE

    MDR report key: 3018961 · Received March 15, 2013

    Report

    Report Number
    3001845648-2013-00028
    Event Type
    Malfunction
    Date Received
    March 15, 2013
    Date of Event
    February 18, 2013
    Report Date
    February 19, 2013
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FCG
    PMA / PMN Number
    K093195
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S COMPLAINT ISSUE WAS CONFIRMED AS FOLLOWS: "WHEN THE NEEDLE WAS WITHDRAWING FROM THE ENDOSCOPE IT WAS NOTED TO BE 'STIFF', WOULD NOT WITHDRAW EASILY AND WHEN IT WAS FULLY REMOVED FROM THE ENDOSCOPE THE BOTTOM OF THE NEEDLE SNAPPED OFF. THERE WAS NO DAMAGE TO THE BRONCHOSCOPE." THERE WERE NO ECHO-HD-22-EBUS-P (ECHO) DEVICES OF LOT #C823681 IN STOCK AT THE TIME OF THE COMPLAINT INVESTIGATION. ONE X ECHO DEVICE OF LOT C823681 WAS RETURNED FOR EVAL. THE DEVICE WAS RETURNED IN THE ORIGINAL PACKAGING AND WAS OPEN ON RECEIPT. THIS ECHO DEVICE WAS RETURNED WITH THE STYLET EXTENDED APPROX 2CM FROM THE HANDLE. IT WAS POSSIBLE TO REMOVE AND INSERT THE STYLET. A KINK WAS NOTED ON THE SHEATH APPROX 2.8CM FROM THE SHEATH EXTENDER. IT IS POSSIBLE THIS KINK OCCURRED DURING THE USE OF THIS DEVICE AS INFORMATION RECEIVED CONFIRMED THIS INCIDENT OCCURRED AT THE FOURTH NEEDLE PASS. WHEN THIS KINK WAS STRAIGHTENED IT WAS POSSIBLE TO ADVANCE AND RETRACT THE NEEDLE. THE NEEDLE WAS EXAMINED UNDER A MICROSCOPE AND WAS CONFIRMED TO BE BROKEN AT THE DISTAL END. NO OTHER ISSUES NOTED WITH THE NEEDLE. ENGINEERING CONFIRMED APPROX 1.5CM OF THE NEEDLE WAS MISSING AND WAS NOT RETURNED. THE PHYSICIAN INVOLVED IN THIS COMPLAINT PROVIDED THE FOLLOWING INFORMATION: "ACCESSING THE TARGET SITE WAS DIFFICULT. THIS WAS THE SECOND PASS INTO THE NODE AND IT WAS NOT COMPLETED BECAUSE OF NEEDLE IMPACTION ON A TRACHEAL CARTILAGE WHEN THE NEEDLE WAS DEPLOYED. THE NEEDLE HAD ALREADY BEEN USED TO UNDERTAKE 2 SAMPLES FROM A SEPARATE L HILAR NODE AND ONE FROM THE PARATRACHEAL NODE SO THIS ATTEMPT WAS THE FOURTH NEEDLE PASS. ENDOSCOPE HAD TO BE IN THE FLEXED POSITION IN ORDER TO MAINTAIN AN ULTRASOUND IMAGE OF THE NODE. IT IS POSSIBLE THAT THE NEEDLE END MAY HAVE BEEN WEAKENED BY THE PREVIOUS THREE PASSES AND THE IMPACT ON TRACHEAL CARTILAGE WAS SUFFICIENT TO KINK THE NEEDLE WHICH THEN FRACTURED AFTER BEING WITHDRAWN INTO THE SHEATH." NO CONCLUSIVE ROOT CAUSE FOR THE NEEDLE BREAKING COULD BE DETERMINED DURING THE LAB INVESTIGATION. NO ISSUES WITH THE FUNCTIONALITY OF THE RETURNED ECHO DEVICE WERE NOTED. THE NEEDLE WAS EXAMINED UNDER A MICROSCOPE AND NO ISSUES WERE NOTED THAT COULD HAVE CONTRIBUTED TO THE BREAKAGE. AS THE PHYSICIAN STATED A CAUSE OF THIS NEEDLE BREAKING COULD BE ATTRIBUTED TO IMPACTION DURING THE PROCEDURE; HOWEVER, AS THE CONDITIONS OF USE CANNOT BE REPLICATED DURING LAB INVESTIGATION, IT IS NOT POSSIBLE TO CONCLUSIVELY STATE IF THIS IS A CAUSE OF THIS NEEDLE BREAKAGE. INFORMATION RECEIVED CONFIRMED THE NEEDLE OF THIS ECHO DEVICE BROKE WHEN THE DEVICE WAS FULLY REMOVED FROM THE ENDOSCOPE. THE LAB INVESTIGATION CONFIRMED APPROX 1.5CM OF THE NEEDLE WAS MISSING. THE PIECE OF THE NEEDLE THAT BROKE WAS NOT RETURNED. INFORMATION RECEIVED CONFIRMED NO PIECE OF THE DEVICE REMAINED INSIDE THE PT AND THERE WERE NO ADVERSE EFFECTS TO THE PT AS A RESULT OF THIS INCIDENT. PRIOR TO DISTRIBUTION, ALL ECHO DEVICES ARE SUBJECTED TO FUNCTIONAL CHECKS AND VISUAL INSPECTION TO ENSURE INTEGRITY OF THE PRODUCT. A REVIEW OF THE RELEVANT MANUFACTURING RECORDS FOR THE ECHO DEVICE INVOLVED IN THIS COMPLAINT DID NOT REVEAL ANY DISCREPANCIES WHICH COULD HAVE CONTRIBUTED TO THE COMPLAINT ISSUE. NO CORRECTIVE ACTION IS REQUIRED AS A RESULT OF THIS COMPLAINT. NO ADVERSE EFFECTS TO THE PT WERE REPORTED. THE 2 YEAR COMPLAINT HISTORY HAS BEEN REVIEWED AND THE LIKELIHOOD OF THIS TYPE OF OCCURRENCE IS LOW. CUSTOMER QUALITY ASSURANCE WILL CONTINUE TO MONITOR COMPLAINTS OF THIS NATURE FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 1

    "WHEN THE NEEDLE WAS WITHDRAWING FROM THE ENDOSCOPE IT WAS NOTED TO BE 'STIFF', WOULD NOT WITHDRAW EASILY AND WHEN IT WAS FULLY REMOVED FROM THE ENDOSCOPE THE BOTTOM END OF THE NEEDLE SNAPPED OFF. THERE WAS NO DAMAGE TO THE BRONCHOSCOPE." A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PT'S BODY. THE PT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTED, THE PT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110069 ECHOTIP ULTRA ENDOBRONCHIAL ULTRASOUND NEEDLE FCG KIT, NEEDLE, BIOPSY FCG COOK IRELAND LTD C823681

    Patients

    Seq Age Sex Outcome Treatment
    1