BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE

    MDR report key: 8854193 · Received August 2, 2019

    Report

    Report Number
    3001845648-2019-00385
    Event Type
    Malfunction
    Date Received
    August 2, 2019
    Date of Event
    July 8, 2019
    Report Date
    August 29, 2019
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FCG
    UDI-DI
    00827002347854
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) # K142688. INVESTIGATION IS STILL PENDING. A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Additional Manufacturer Narrative · 0

    PMA/510(K) # K142688. THE ECHO-HD-3-20-C DEVICE OF LOT NUMBER C1594386 INVOLVED IN THIS COMPLAINT WAS RETURNED FOR EVALUATION, WITH THE ORIGINAL PACKAGING. THE PACKAGING WAS OPEN ON RECEIPT. WITH THE INFORMATION PROVIDED, A PHYSICAL EXAMINATION AND DOCUMENT BASED INVESTIGATION WAS CONDUCTED. THE DEVICE RELATED TO THIS OCCURRENCE UNDERWENT A LABORATORY EVALUATION ON THE 31JUL2019. THERE WAS A DISTAL KINK IN THE NOTCH AREA, LEUR (MLLA) OFF CENTRE. PROXIMAL BREAK BELOW SHEATH EXTENDER. 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. A REVIEW OF THE RELEVANT MANUFACTURING RECORDS (C1594386) REVEALED NO DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT. THE NOTES SECTION OF THE INSTRUCTIONS FOR USE, WHICH ACCOMPANIES THIS DEVICE INSTRUCTS THE USER TO INSPECT THE DEVICE PRIOR TO USE : "VISUALLY INSPECT WITH PARTICULAR ATTENTION TO KINKS, BENDS AND BREAKS. IF AN ABNORMALITY IS DETECTED THAT WOULD PROHIBIT PROPER WORKING CONDITION, DO NOT USE". THERE IS NO EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO BE EXCESSIVE FORCE DURING USE WHILE THE SCOPE WAS IN A FLEXED POSITION, WHICH BROKE THE NEEDLE. COMPLAINT IS CONFIRMED BASED ON THE LABORATORY EVALUATION. ACCORDING TO THE INITIAL REPORTER, THE PATIENT 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 · 0

    THE NEEDLE WAS USED TO TAKE 2 SAMPLES OF A PANCREATIC MASS AS PER THE IFU. AFTER THE SECOND PASS THE NEEDLE WAS REMOVED FROM THE SCOPE AND THE NURSES WERE TRYING TO PLACE THE SECOND SAMPLE INTO A POT. WHEN REINSERTING THE STYLET IT BECAME APPARENT THE NEEDLE HAD BROKEN AS ALTHOUGH THE SAFETY RING WAS LOCKED ON 2CM THE NEEDLE WAS PROTRUDING APPROX. 10CM OUT OF THE END OF THE SHEATH AND CONTINUED TO MOVE OUT AS THE STYLET WAS PUSHED IN. THE DEVICE WAS THEN PUT ASIDE AND ANOTHER PROCORE 20 NEEDLE WAS USED TO COMPLETE THE PROCEDURE.

    Description of Event or Problem · 0

    THE NEEDLE WAS USED TO TAKE 2 SAMPLES OF A PANCREATIC MASS AS PER THE IFU. AFTER THE SECOND PASS THE NEEDLE WAS REMOVED FROM THE SCOPE AND THE NURSES WERE TRYING TO PLACE THE SECOND SAMPLE INTO A POT. WHEN REINSERTING THE STYLET IT BECAME APPARENT THE NEEDLE HAD BROKEN AS ALTHOUGH THE SAFETY RING WAS LOCKED ON 2CM THE NEEDLE WAS PROTRUDING APPROX. 10CM OUT OF THE END OF THE SHEATH AND CONTINUED TO MOVE OUT AS THE STYLET WAS PUSHED IN. THE DEVICE WAS THEN PUT ASIDE AND ANOTHER PROCORE 20 NEEDLE WAS USED TO COMPLETE THE PROCEDURE.

    Additional Manufacturer Narrative · 1

    PMA/510(K) # K142688. INVESTIGATION IS STILL PENDING. A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Description of Event or Problem · 1

    THE NEEDLE WAS USED TO TAKE 2 SAMPLES OF A PANCREATIC MASS AS PER THE IFU. AFTER THE SECOND PASS THE NEEDLE WAS REMOVED FROM THE SCOPE AND THE NURSES WERE TRYING TO PLACE THE SECOND SAMPLE INTO A POT. WHEN REINSERTING THE STYLET IT BECAME APPARENT THE NEEDLE HAD BROKEN AS ALTHOUGH THE SAFETY RING WAS LOCKED ON 2CM THE NEEDLE WAS PROTRUDING APPROX. 10CM OUT OF THE END OF THE SHEATH AND CONTINUED TO MOVE OUT AS THE STYLET WAS PUSHED IN. THE DEVICE WAS THEN PUT ASIDE AND ANOTHER PROCORE 20 NEEDLE WAS USED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    652022 ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE FCG KIT, NEEDLE, BIOPSY FCG COOK IRELAND LTD G34785 C1594386 00827002347854

    Patients

    Seq Age Sex Outcome Treatment
    1