BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHOTIP ULTRA HIGH DEFINITION ULTRASOUND ACCESS NEEDLE

    MDR report key: 6834276 · Received August 31, 2017

    Report

    Report Number
    3001845648-2017-00372
    Event Type
    Malfunction
    Date Received
    August 31, 2017
    Report Date
    October 6, 2017
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FCG
    UDI-DI
    00827002520127
    PMA / PMN Number
    K092359
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    COOK IRELAND LTD (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI)(IMPORTER). EXEMPTION NUMBER: E2016031. INFORMATION PERTAINING TO SECTION G.1 AS FOLLOWS: IMPORTER SITE CONTACT AND ADDRESS: (B)(4) COOK MEDICAL INCORPORATED (CMI) 1025 ACUFF ROAD P.O BOX 4195 BLOOMINGTON INDIANA 47402-4195 IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: 3005580113 ADDITIONAL INFORMATION WAS REQUESTED 08 AUG: WAS THE NEEDLE INTENTIONALLY CUT? (WAS THE NEEDLE CUT BY THE USER IN ORDER TO REMOVE DEVICE FROM THE SCOPE?) PLEASE CLARIFY IF THE NEEDLE BROKE DURING THE PROCEDURE. DURING THE INITIAL PASS WAS THE STYLET IN PLACE? WERE THEY ABLE TO SEE THE SHEATH EXITING THE SCOPE? WAS IT THE NEEDLE OR THE NEEDLE TIP THEY HAD TROUBLE VISUALIZING? DID THEY KINK THE NEEDLE ON LOADING / REMOVAL OF THE DEVICE FROM THE SCOPE? 1 X ECHO-HD-19-A WAS RETURNED TO CIRL FOR EVALUATION. UPON EVALUATION OF THE RETURNED DEVICE THE FOLLOWING WAS NOTED: THE STYLET WAS RETURNED BUT NOT IN PLACE. THERE WAS NO NEEDLE EXPOSURE. THE NEEDLE WAS BROKEN BELOW THE SHEATH EXTENDER. THE DIMPLES ARE PRESENT ON THE NEEDLE TIP (DISTAL END) IT IS ASSUMED THE NEEDLE/SHEATH WAS CUT BY THE USER THIS IS INDICATED BY COMPRESSED ENDS, BUT THE NEEDLE WAS FULLY COVERED AT BOTH ENDS BY THE SHEATH. THE NEEDLE BROKE AT 76.5CM FROM THE DISTAL TIP OF THE NEEDLE. THE SHEATH MEASURES 77.1CM. NOTE: THE SHEATH WAS CUT BY ENGINEERING IN ORDER TO GET TO THE NEEDLE. THE CUSTOMER COMPLAINT IS CONFIRMED AS THE NEEDLE IS BROKEN BELOW THE SHEATH EXTENDER. A POSSIBLE ROOT CAUSE OF THIS OCCURRENCE COULD BE THAT THE DEVICE BROKE WHEN LOADING IT ONTO THE SCOPE WHICH IN TURN CAUSED ADVANCEMENT ISSUES WHICH LEAD TO THE VISUALIZATION ISSUE HOWEVER THE EXACT OPERATIONAL CONDITIONS CANNOT BE REPLICATED IN THE LAB. PRIOR TO DISTRIBUTION, ALL ECHO-HD-19-A 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. THE INSTRUCTIONS FOR USE, ADVISES THE USER TO ¿IF AN ABNORMALITY IS DETECTED THAT WOULD PROHIBIT PROPER WORKING CONDITION, DO NOT USE.¿ FROM THE INFORMATION PROVIDED, 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

    THIS INITIAL MDR IS BEING SUBMITTED AS THE NEEDLE WAS RECEIVED BROKEN ON RETURN. DOCTOR COULD NOT VIEW THE DEVICE UNDER ULTRASOUND.

    Additional Manufacturer Narrative · 1

    (B)(4). EXEMPTION NUMBER: E2016031. IMPORTER SITE CONTACT AND ADDRESS: (B)(4). IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: (B)(4). 1 X ECHO-HD-19-A WAS RETURNED TO CIRL FOR EVALUATION. UPON EVALUATION OF THE RETURNED DEVICE THE FOLLOWING WAS NOTED: THE STYLET WAS RETURNED BUT NOT IN PLACE. THERE WAS NO NEEDLE EXPOSURE. THE NEEDLE/SHEATH APPEAR TO HAVE BEEN CUT AT APPROXIMATELY 76.5CM FROM THE DISTAL TIP OF THE NEEDLE. THE CUT/SHEATH MEASURES AT APPROXIMATELY 77.1CM. THE DIMPLES ARE PRESENT ON THE NEEDLE TIP (DISTAL END) IT IS ASSUMED THE NEEDLE/SHEATH WAS CUT BY THE USER THIS IS INDICATED BY COMPRESSED ENDS, BUT THE NEEDLE WAS FULLY COVERED AT BOTH ENDS BY THE SHEATH. THE SHEATH THAT REMAINED ATTACHED TO THE HANDLE WAS CUT BY ENGINEERING IN ORDER TO GET TO THE NEEDLE. THE NEEDLE WAS BROKEN BELOW THE SHEATH EXTENDER THERE WAS A NOTE ATTACHED TO THE PACKAGING WHICH STATED "ALSO, WHEN WE TRIED TO PUT THE NEEDLE BACK IN THE PACKAGE, PART OF IT SNAPPED AND BROKE" .THIS WAS DISCOVERED AFTER THE LAB EVALUATION. THIS NOTE RELATES TO THE BREAK BELOW THE SHEATH EXTENDER. THE CUSTOMER COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. A POSSIBLE ROOT CAUSE OF THIS OCCURRENCE COULD BE RELATED TO PATIENT ANATOMY WHICH CAN CONTRIBUTE TO VISUALIZATION ISSUES HOWEVER THE EXACT OPERATIONAL CONDITIONS CANNOT BE REPLICATED IN THE LAB. PRIOR TO DISTRIBUTION, ALL ECHO-HD-19-A 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. THE INSTRUCTIONS FOR USE, ADVISES THE USER TO ¿IF AN ABNORMALITY IS DETECTED THAT WOULD PROHIBIT PROPER WORKING CONDITION, DO NOT USE.¿ A REVIEW THE MANUFACTURING RECORDS FOR ECHO DEVICES OF LOT # C1245724 SHOWED NO DISCREPANCIES WERE REVEALED THAT WOULD BE RELATED TO THE COMPLAINT ISSUE. FROM THE INFORMATION PROVIDED, 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 · 1

    THIS FOLLOW UP MDR IS BEING SUBMITTED TO INCLUDE THE POSSIBLE ROOT CAUSE. DOCTOR COULD NOT VIEW THE DEVICE UNDER ULTRASOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    615994 ECHOTIP ULTRA HIGH DEFINITION ULTRASOUND ACCESS NEEDLE FCG KIT, NEEDLE, BIOPSY FCG COOK IRELAND LTD G52012 00827002520127

    Patients

    Seq Age Sex Outcome Treatment
    1