BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE

    MDR report key: 3851595 · Received April 18, 2014

    Report

    Report Number
    3001845648-2014-00067
    Event Type
    Malfunction
    Date Received
    April 18, 2014
    Report Date
    March 24, 2014
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FCG
    PMA / PMN Number
    K083330
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT REPORT MEETS THE REPORTING CRITERIA OF AN FDA MDR REPORT BASED ON THE REPORTING PRECEDENCE ESTABLISHED FOR THIS PRODUCT FAMILY FOR THE NON RETRACTION OF THE NEEDLE DURING USE AND PROXIMAL NEEDLE BREAKAGE; REGARDLESS OF PT OUTCOME. THE COMPLAINT INFO PROVIDED WAS AS FOLLOWS: "AS THEY WITHDREW THE NEEDLE TO COLLECT TISSUE, THE NEEDLE BECAME STUCK IN THE OUTSIDE POSITION OUT OF THE SHEATH AND THE HANDLE BROKE." ADDITIONAL INFO REPORTED THAT THE REP PRESENT WHEN THE SAME PHYSICIAN DR. WYSE RE-SCOPED THE SAME PT. HE USED ANOTHER COOK ECHO-25 NEEDLE THAT WORKED FLAWLESSLY. THE REP DID NOTICE THAT HIS SCOPE POSITION WAS VERY AWKWARD AS IT REQUIRED BOTH NURSES TO HOLD VARIOUS PORTIONS OF THE SCOPE BEFORE INTRODUCING THE NEEDLE. THERE WERE NO ECHO-25 (ECHO) DEVICES OF LOT # C959119 IN STOCK AT THE TIME OF THE COMPLAINT INVESTIGATION. 2 X ECHO DEVICES OF LOT # C959119 WERE RETURNED FOR EVALUATION. ONE DEVICE WAS RETURNED IN THE ORIGINAL PACKAGE AND WAS OPENED ON RECEIPT AND THE SECOND DEVICE WAS RETURNED IN A SEALED PACKAGE. THIS ECHO DEVICE WAS RETURNED IN THREE SEPARATE PARTS. THE NEEDLE AND SHEATH WERE BROKEN APART FROM THE ECHO DEVICE APPROX. 1.7 CM BELOW THE SHEATH EXTENDER, WHEN THE SHEATH EXTENDER WAS POSITIONED AT REFERENCE MARK 5. A SEVERE KINK WAS OBSERVED ON THE EXPOSED PART OF NEEDLE ATTACHED TO THE ECHO HANDLE, HOWEVER NO KINKS WERE NOTED ON THE SHEATH ATTACHED TO THE ECHO HANDLE, HOWEVER NO KINKS WERE NOTED ON THE SHEATH ATTACHED TO THE ECHO HANDLE, BELOW THE SHEATH EXTENDER. THE SHEATH THAT HAD SEPARATED FROM THE DEVICE MEASURED APPROX. 140.5 CM AND WAS NOTED TO BE DAMAGED AT THE PROXIMAL END, INDICATING THAT FORCE WAS REQUIRED TO SEPARATE THE SHEATH. THE STYLET WAS RETURNED OUTSIDE THE DEVICE. THE STYLET WAS INSERTED INTO THE DEVICE HOWEVER IT COULD NOT BE ADVANCED; RESISTANCE WAS ENCOUNTERED AT THE PROXIMAL END OF THE HANDLE. THE DISTAL NEEDLE TIP AS EXAMINED AND WAS CONFIRMED TO BE INTACT. THERE WAS NO DAMAGE OBSERVED TO THE NOTCH OF THE NEEDLE. TO FURTHER EVALUATE THIS COMPLAINT THE HANDLE OF THE DEVICE WAS DISMANTLED AND THE NEEDLE WAS REMOVED FROM THE DEVICE. THE NEEDLE WAS CONFIRMED TO BE BROKEN APPROX. 3.5CM FROM THE BASE OF THE PROXIMAL LUER LOCK; THIS COINCIDES WITH A BREAKAGE AT THE PROXIMAL END OF THE HANDLE. THE POINT AT WHICH THE NEEDLE BREAKAGE OCCURRED WAS CONFIRMED TO BE KINKED. THE SECOND POINT OF NEEDLE BREAKAGE WAS APPROX. 25 CM FROM THE BASE OF THE PROXIMAL LUER LOCK; COINCIDING WITH A NEEDLE BREAKAGE BELOW THE SHEATH EXTENDER. THE DEVICE THAT WAS RETURNED IN THE SEALED PACKAGE WAS OPENED AND WAS CONFIRMED TO FUNCTION AS INTENDED. THE NEEDLE COULD BE ADVANCED AND RETRACTED EASILY WITHOUT ISSUE. THE CUSTOMER COMPLAINT WAS CONFIRMED AS NEEDLE BREAKAGE WAS CONFIRMED IN THE HANDLE AND BELOW THE SHEATH EXTENDER. IT WAS DETERMINED DURING THE DEVICE EVALUATION THAT THE CAUSE OF THE NEEDLE BREAKAGE AT THE PROXIMAL END OF THE HANDLE MAY BE ATTRIBUTED TO THE NEEDLE KINKING AT THIS POINT. A POSSIBLE CAUSE OF THE NEEDLE KINKING WITHIN THE HANDLE MAY BE DUE TO PT ANATOMY IF THE LESION BEING PUNCTURED WAS A HARD LESION AND REQUIRED A PARTICULARLY FORCEFUL ADVANCEMENT OF THE NEEDLE. AS THE NEEDLE WAS ADVANCED/RETRACTED DURING THE PROCEDURE THE KINK WOULD HAVE RESULTED IN A NEEDLE BREAKAGE AND ACCOUNT FOR THE DIFFICULTY THE CUSTOMER EXPERIENCED WITH NEEDLE ADVANCEMENT/RETRACTION. THE COMPLAINT INFO RECEIVED INDICATED THAT GAINING ACCESS TO THE TARGETED SITE WAS DIFFICULT AND NEEDLE PENETRATION INTO THE TARGET SITE WAS DIFFICULT; THE ENDOSCOPE WAS POSITIONED AT D2 (VERY TORQUED) TWISTED POSITION DURING THE PROCEDURE. IT WAS ALSO CONFIRMED THAT THE STYLET WAS REMOVED BEFORE THE NEEDLE WAS ADVANCED IN THE ENDOSCOPE. AS PER THE INSTRUCTIONS FOR USE THE USER IS NOT INSTRUCTED TO REMOVE THE STYLET UNTIL AFTER THE NEEDLE HAS BEEN ADVANCED INTO THE LESION. SEE SCANNED PAGE. THESE CONDITIONS MAY HAVE CONTRIBUTED TO NEEDLE BREAKAGE. AS THE CONDITIONS OF DEVICE USAGE COULD NOT BE REPLICATED DURING THE LAB EVALUATION THE ROOT CAUSE COULD NOT BBE CONCLUSIVELY DETERMINED. PRIOR TO DISTRIBUTION, ALL ECHO DEVICES ARE SUBJECTED TO FUNCTIONAL CHECKS AND VISUAL INSPECTION TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE MFG RECORDS FOR ECHO DEVICES OF LOT # SPECIFIED ABOVE DID NOT REVEAL ANY DISCREPANCIES RELATED TO THE COMPLAINT ISSUE. THE COMPLAINT INFO RECEIVED INDICATED THAT NO PART OF THE NEEDLE BROKE INSIDE OF THE PT. IT WAS CONFIRMED THAT THE PT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 1

    AS THEY WITHDREW THE NEEDLE TO COLLECT THE TISSUE, THE NEEDLE BECAME STUCK IN THE OUTSIDE POSITION OUT OF THE SHEATH AND THE HANDLE BROKE. ON RECEIPT OF THE DEVICE THE NEEDLE WAS ALSO CONFIRMED TO BE BROKEN. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PT'S BODY. THE PT WAS RESCHEDULED FOR AN ADDITIONAL PROCEDURE TO HAVE THE PROCEDURE COMPLETED DUE TO THIS OCCURENCE. ACCORDING TO THE INITIAL REPORTER, THE PT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238173 ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE FCG KIT, NEEDLE, BIOPSY FCG COOK IRELAND LTD C959119

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK