BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE

    MDR report key: 6499615 · Received April 18, 2017

    Report

    Report Number
    3001845648-2017-00129
    Event Type
    Malfunction
    Date Received
    April 18, 2017
    Date of Event
    March 22, 2017
    Report Date
    March 22, 2017
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FCG
    UDI-DI
    00827002347854
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    PHYSICIAN

    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. PMA/510(K) #K142688. 3 X ECHO-HD-3-20-C LOT NUMBER C1326743 WAS RETURNED TO CIRL FOR EVALUATION. UPON EVALUATION OF THE RETURNED DEVICE, IT WAS NOTED TWO UNUSED DEVICES WERE RETURNED ALONG WITH ONE USED DEVICE. THE USED DEVICE, THE NEEDLE WAS IN SHEATH UPON RETURN, THE STYLET WAS IN PLACE. THERE WAS A WRINKLE NOTED IN THE SHEATH. THE NEEDLE WAS ABLE TO BE ADVANCED AND RETRACTED. THE NEEDLE WAS BROKEN AT THE NOTCH. THE BROKEN TIP WAS RETURNED, AS PER INFORMATION PROVIDED THE STYLET WAS NOT FULLY INSERTED WHEN PENETRATING THE TARGET SITE THEREFORE, THIS COMPLAINT IS DEEMED USER-ERROR. THE CUSTOMER COMPLAINT WAS CONFIRMED AS THE NEEDLE BROKEN- USER ERROR. AS PER THE INSTRUCTIONS FOR USE: "ENSURE THE STYLET IS FULLY INSERTED WHEN ADVANCING THE NEEDLE INTO BIOPSY SITE" 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 MANUFACTURING RECORDS FOR ECHO-HD-3-20-C OF LOT NUMBER C1326743 DID NOT REVEAL ANY DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS 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 · 0

    DR (B)(6) & HIS TRAINEE, DR (B)(6), WERE UNDERTAKING EUS-FNB IN A MALE PATIENT WITH A LARGE PANCREATIC MASS WITH INVASION INTO SURROUNDING STRUCTURES. A FIRST PASS WAS COMPLETED SUCCESSFULLY AND LARGE SPECIMEN RETRIEVED WITH NO INDICATION OF EQUIPMENT FAILURE. UPON EXPELLING THE SAMPLE, DR (B)(6) NOTED THAT HE THOUGHT THE NEEDLE TIP LOOKED SLIGHTLY BENT, HOWEVER ON INSPECTION NO VISIBLE DAMAGE COULD BE SEEN THE CHOICE WAS MADE TO CONTINUE WITH A SECOND PASS. THE SCOPE WAS THEN HANDED TO DR (B)(6), WHO WANTED TO EVALUATE THE FEELING OF THE NEEDLE. IT WAS NOTED THAT DR (B)(6) EXPERIENCED DIFFICULTY PENETRATING THE LESION, HOWEVER AFTER 3-4 ATTEMPTS, WAS ABLE TO GAIN ACCESS TO THE SITE. AFTER REMOVING THE DEVICE, THE NEEDLE WAS ADVANCED TO RETRIEVE THE SECOND SAMPLE WHERE THE ASSISTING NURSE NOTICED THE NEEDLE WAS BENT AT A 90 DEGREE ANGLE AT THE CORE TRAP, WHICH WAS SUBSEQUENTLY REMOVED TO EXPEL AND FINISH THE CASE. UPON DISCUSSION, THE GENTS INDICATED THEY MAY HAVE SLIGHTLY RETRACED THE STYLET WHEN PENETRATING THE TARGET SITE. THE BROKEN TIP AND DEVICE WERE RETRIEVED FOR RETURN AND INSPECTION, ALONG WITH TWO UNUSED PRODUCTS OF THE SAME LOT NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281788 ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE FCG KIT, NEEDLE, BIOPSY FCG COOK IRELAND LTD 00827002347854

    Patients

    Seq Age Sex Outcome Treatment
    1