BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHO TIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE

    MDR report key: 3943543 · Received April 30, 2014

    Report

    Report Number
    3001845648-2014-00074
    Event Type
    Malfunction
    Date Received
    April 30, 2014
    Date of Event
    April 1, 2014
    Report Date
    April 1, 2014
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FCG
    PMA / PMN Number
    K083330
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER HAS INDICATED THE NEEDLE COULD NOT BE RETRACTED DURING USE. THIS COMPLAINT IS REPORTABLE TO THE FDA ON THE BASIS OF A PREVIOUS ADVERSE EVENT FOR AN ECHO-HD-19-C. THE REPORTING PRECEDENCE COVERS THE ENTIRE PRODUCT FAMILY. THEREFORE ALL ECHO DEVICES INVOLVING A PROXIMAL NEEDLE BREAKAGE AND OR THE NON RETRACTION OF THE NEEDLE ARE REPORTABLE REGARDLESS OF PATIENT OUTCOME. THE CUSTOMERS' COMPLAINT ISSUE WAS REPORTED AS FOLLOWS: THE NEEDLE NOTCH BECAME BENT AND NEEDLE COULD NOT BE RETRACTED INTO THE SHEATH, SO THE DEVICE WAS REMOVED FROM THE ENDOSCOPE WITH THE NEEDLE TIP OUT OF THE SHEATH. ANOTHER PRODUCT WAS USED TO COMPLETE THE PROCEDURE. WHEN THE SALES REP WAS PLACING THE DEVICE IN A PLASTIC BAG, THE NEEDLE TIP GOT CAUGHT IN THE PLASTIC BAG AND BROKE AT THE BENT PART IN THE NOTCH. THERE WERE NO ECHO-HD-19-C (ECHO) DEVICES OF LOT# C920954 IN STOCK AT THE TIME OF THE COMPLAINT INVESTIGATION. 1 X ECHO DEVICE OF UNKNOWN LOT NUMBER WAS RETURNED FOR EVALUATION. THE DEVICE WAS NOT RETURNED IN THE ORIGINAL PACKAGE AND WAS OPENED ON RECEIPT. THIS ECHO DEVICE WAS RECEIVED WITH THE NEEDLE FULLY RETRACTED AND THE STYLET FULLY INSERTED THROUGH THE DEVICE. UPON EVALUATION OF THIS ECHO DEVICE IT WAS POSSIBLE TO ADVANCE/RETRACT THE NEEDLE. THE NEEDLE EXTENSION WAS EXAMINED AND CONFIRMED BROKEN AT THE DISTAL TIP OF THE NEEDLE. THE DISTAL TIP OF THE SHEATH WAS NOTED TO BE PERFORATED. A SMALL SECTION OF THE SHEATH AT THE DISTAL TIP WAS MISSING DUE TO THE PERFORATION. THE BROKEN NEEDLE PIECE WAS RETURNED. IT WAS CONFIRMED TO BE THE DISTAL NEEDLE TIP OF THIS ECHO DEVICE. THE NEEDLE PIECE MEASURED APPROX 4MM. EXAMINATION UNDER A MICROSCOPE CONFIRMED THE NEEDLE WAS BROKEN AT THE NOTCH/CORE TRAP. THE TIP WAS NOTED TO BE SEVERELY BENT AND KINKED. THE BROKEN NEEDLE TIP RETURNED CORRESPONDED WITH THE DISTAL NEEDLE END OF THIS ECHO DEVICE. ALL PARTS OF THE NEEDLE OF THIS ECHO DEVICE WERE ACCOUNTED FOR DURING THE LABORATORY EVALUATION. THE CUSTOMER COMPLAINT WAS CONFIRMED ON RETURN OF THE DEVICE AS THE DISTAL PART OF THE NEEDLE WAS CONFIRMED TO BE BROKEN APPROX. 4MM FROM THE TIP OF THE NEEDLE AT THE NOTCH. THE NEEDLE TIP WAS ALSO NOTED TO BE SEVERELY KINKED. THE MOST LIKELY CAUSE OF THIS COMPLAINT IS THAT THE NEEDLE BENT AT THE NOTCH DURING USE RESULTING IN A NEEDLE BREAKAGE. THE NEEDLE BENDING AT THE NOTCH MAY BE ATTRIBUTED TO THE PHYSICIAN ADJUSTING THE NEEDLE POSITION USING THE ELEVATOR OF THE ENDOSCOPE. THE COMPLAINT INFORMATION REPORTED INDICATED THAT IT WAS A DIFFICULT PROCEDURE. THE ENDOSCOPE WAS CONFIRMED TO BE IN A FLEXED/TWISTED POSITION. GAINING ACCESS TO THE TARGETED SITE AND NEEDLE PENETRATION OF THE TARGETED SITE WERE DIFFICULT. THESE CONDITIONS MAY ALSO HAVE CONTRIBUTED TO THE NEEDLE BENDING AT NOTCH AND NEEDLE TIP. IF THE DISTAL TIP OF THE NEEDLE WAS DAMAGED THIS MAY ACCOUNT FOR THE USERS' DIFFICULTY IN RETRACTING THE NEEDLE. THE NOTCH OF THE NEEDLE CAN GET CAUGHT IN SHEATH TIP DUE TO IMPROPER HANDLING OF THE DEVICE DURING THE USE. IF THE ENDOSCOPE WAS IN A TORQUED OR FLEXED POSITION DURING THE PROCEDURE, THIS MAY HAVE CONTRIBUTED TO THE ISSUE. THE NEEDLE NOTCH MOST LIKELY GOT CAUGHT ON THE SHEATH WHEN THE USER WAS RETRACTING THE NEEDLE INTO THE SHEATH, RESULTING IN THE SHEATH PERFORATION. AS THE CONDITIONS OF DEVICE USAGE CANNOT BE REPLICATED DURING THE LABORATORY EVALUATION IT IS NOT POSSIBLE TO CONCLUSIVELY STATE IF THIS IS THE CAUSE OF THIS COMPLAINT. IT WAS CONFIRMED THAT THE NEEDLE BROKE OUTSIDE OF THE PATIENT DURING AN ATTEMPT TO RETRACT THE NEEDLE. THE NEEDLE WAS REMOVED FROM THE PATIENT UNRETRACTED. PRIOR TO DISTRIBUTION, ALL ECHO DEVICES ARE SUBJECTED TO FUNCTIONAL CHECKS AND VISUAL INSPECTION TO ENSURE INTEGRITY OF THE PRODUCT. A REVIEW OF THE MANUFACTURING RECORDS FOR C920954 DETERMINED NO ISSUES WHICH MAY HAVE ATTRIBUTED TO THIS FAILURE. THE NOTES SECTION OF THE INSTRUCTIONS FOR USE 1FU0077-2 THAT ACCOMPANIES THIS DEVICE INSTRUCTS THE USER TO "VISUALLY INSPECT WITH PARTICULAR ATTENTION TO KINKS, BENDS AND BREAKS. IF AN ABNORMALITY IS DETECTED THAT WOULD PROHIBIT PROPER WORKING CONDITION, DO NOT USE". IT WAS CONFIRMED THAT THE NEEDLE BROKE OUTSIDE OF THE PATIENT. NO ADVERSE EFFECTS TO THE PATIENT WERE REPORTED AS A RESULT OF THIS OCCURRENCE. A SECOND NEEDLE WAS USED TO COMPLETE THE PROCEDURE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 1

    THE PHYSICIAN PLANNED TO PUNCTURE THE PANCREAS VIA THE STOMACH BUT THE TARGET SITE WAS FAR FROM THE STOMACH, SO THE DOCTOR HAD TO USE LEFT/RIGHT ANGLE A LOT. IT WAS DIFFICULT PUNCTURE. WHEN HE WAS REMOVING THE NEEDLE FROM THE SCOPE, HE ADJUSTED THE NEEDLE POSITION USING THE ELEVATOR OF THE ENDOSCOPE AND HE NEEDLE NOTCH BECAME BENT. THE NEEDLE COULD NOT BE RETRACTED IN THE SHEATH, SO HE REMOVED THE DEVICE AS THE NEEDLE TIP WAS OUT OF THE SHEATH FROM THE ENDOSCOPE. ANOTHER PRODUCT WAS USED TO COMPLETE THE PROCEDURE. WHEN THE SALES REP PUT THE DEVICE IN A PLASTIC BAG, THE NEEDLE TIP GOT CAUGHT IN THE PLASTIC BAG AND BROKE AT THE BENT PART IN THE NOTCH. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DOE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258511 ECHO TIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE FCG KIT, NEEDLE, BIOPSY FCG COOK IRELAND LTD C920954

    Patients

    Seq Age Sex Outcome Treatment
    1