BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE

    MDR report key: 4021338 · Received July 9, 2014

    Report

    Report Number
    3001845648-2014-00127
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    June 10, 2014
    Report Date
    June 10, 2014
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FCG
    PMA / PMN Number
    K083330
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT REPORT MEETS THE REPORTING CRITERIA OF AN FDA MDR REPORT BASE DON THE REPORTING PRECEDENCE ESTABLISHED FOR THIS PRODUCT FAMILY FOR THE NON RETRACTION OF THE NEEDLE; REGARDLESS OF PATIENT OUTCOME. THIS REPORT IS RELATED TO REPORT REF #3001845648-2014-00128. THERE WERE NO ECHO-HD-19-C (ECHO) DEVICES OF LOT # C974535 IN STOCK AT THE TIME OF THE COMPLAINT INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED FOR EVALUATION, THEREFORE A DOCUMENT BASED INVESTIGATION WAS CARRIED OUT. DUE TO LIMITED INFORMATION PROVIDED FOR THIS COMPLAINT IT IS NOT POSSIBLE TO DETERMINE THE CAUSE OF THE CUSTOMERS DIFFICULTY. THE MOST LIKELY CAUSE OF THIS COMPLAINT IS THAT THE NEEDLE MAY HAVE BEEN DAMAGED ON ITS INTRODUCTION INTO THE ENDOSCOPE OR IF THE DEVICE WAS BEING USED IN A TORTUOUS ANATOMY. IF THE NEEDLE WAS KINKED/BENT DURING USE THIS COULD PREVENT NEEDLE RETRACTION INTO THE SHEATH. AS THE DEVICE WAS NOT RETURNED FOR EVALUATION AND CONDITIONS OF DEVICE USAGE CANNOT BE REPLICATED IN THE LABORATORY IT IS NOT POSSIBLE TO DEFINITIVELY STATE IF THIS IS THE ROOT CAUSE OF THE COMPLAINT. THE CUSTOMER COMPLAINT WAS CONFIRMED BASED ON THE CUSTOMER TESTIMONY. THE COMPLAINT INFORMATION RECEIVED INDICATED THAT NO SECTION OF THE DEVICE REMAINED 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 DUE TO THIS OCCURRENCE. PRIOR TO DISTRIBUTION, ALL ECHO DEVICES ARE SUBJECTED TO FUNCTIONAL CHECKS AND VISUAL INSPECTION TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE MANUFACTURING RECORDS DID NOT REVEAL A DISCREPANCY WHICH COULD HAVE CONTRIBUTED TO THE COMPLAINT ISSUE. IT WAS CONFIRMED THAT 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

    DURING AN ENDOSCOPIC ULTRASONOGRAPHY (EUS) PROCEDURE, WHEN THE PHYSICIAN ATTEMPTED TO INTRODUCE THE NEEDLE INTO THE ATRIUM OF THE STOMACH THE NEEDLE WOULD NOT EXIT THE SHEATH. ATTEMPTED TO RETRACT THE NEEDLE BACK UP THE SHEATH AND THE NEEDLE WOULD NOT RETRACT (THIS REPORT). THE WHOLE DEVICE WAS REMOVED FROM THE SCOPE AND ANOTHER OF THE SAME WITH LOT NUMBER C904981 WAS USED TO PROCEED. THE PHYSICIAN EXPERIENCED THE SAME OCCURRENCE WITH THIS NEEDLE AS WELL (REPORT REF #3001845648-2014-00128). THIS DEVICE WAS ALSO REMOVED AND THE PROCEDURE WAS COMPLETED WITH A 22 GAUGE NEEDLE. NO ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED AS OCCURRING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400903 ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE FCG, KIT, NEELDE, BIOPSY FCG COOK IRELAND LTD C974535

    Patients

    Seq Age Sex Outcome Treatment
    1