BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE

    MDR report key: 3057603 · Received April 9, 2013

    Report

    Report Number
    3001845648-2013-00033
    Event Type
    Malfunction
    Date Received
    April 9, 2013
    Date of Event
    February 18, 2013
    Report Date
    March 13, 2013
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FCG
    PMA / PMN Number
    K083330
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER REPORTED THE FOLLOWING COMPLAINT ISSUE: "AT THE FIRST USE THE NEEDLE DID NOT EXIT FROM THE SHEATH. THE DOCTOR TRIED TO REMOVE THE NEEDLE FROM THE ECHO ENDOSCOPE BUT THE NEEDLE WAS BLOCKED. HE FINALLY SUCCEEDED TO REMOVE IT WHEN IT BROKE AND THE PROXIMAL PART." THERE WERE NO ECHO-HD-25-C (ECHO) DEVICES OF LOT # C813573 IN STOCK AT THE TIME OF THE COMPLAINT INVESTIGATION. 1 X ECHO DEVICE OF LOT # C813573 WAS RETURNED FOR EVALUATION. THE DEVICE WAS RETURNED IN THE ORIGINAL PACKAGING AND WAS OPENED ON RECEIPT. THIS ECHO DEVICE WAS RETURNED WITH THE OUTER HANDLE DETACHED FROM THE INNER HANDLE. THE STYLET WAS RETURNED INSERTED IN THE DEVICE. APPROX 45 CM OF THE PROXIMAL END OF THE NEEDLE AND STYLET WAS EXPOSED BETWEEN THE DETACHED OUTER HANDLE AND THE INNER HANDLE. THE NEEDLE WAS CONFIRMED BROKEN AT APPROX 22 CM FROM THE PROXIMAL END OF THE NEEDLE. THE INSERTED STYLET WAS HOLDING THE BROKEN NEEDLE TOGETHER. A KINK WAS ALSO NOTED ON THE NEEDLE AT APPROX 41 CM FROM THE PROXIMAL END OF THE NEEDLE. DURING THE LABORATORY EVALUATION GLUE WAS EVIDENT ON THE JOINTS OF THE OUTER HANDLE INDICATING NO ISSUE WITH THE MANUFACTURING GLUING PROCESS. THEREFORE THE CAUSE OF THE OUTER HANDLE DETACHING FROM THE INNER HANDLE HAS BEEN ATTRIBUTED TO EXCESSIVE FORCE IN THE HANDLING OF THIS ECHO DEVICE. IT WAS NOTED THAT A POSSIBLE CAUSE OF THE NEEDLE BREAKING WAS DUE TO A KINK ON THE NEEDLE. ADDITIONAL FORCE DURING THE ATTEMPT BY THE USER TO ADVANCE/ RETRACT THE NEEDLE MAY HAVE CONTRIBUTED TO THIS KINK RESULTING IN A NEEDLE BREAKAGE. IT IS ALSO POSSIBLE THAT THE INITIAL DIFFICULTY EXPERIENCED BY THE USER IN ADVANCING THE NEEDLE MAY BE DUE TO THE NEEDLE BEING KINKED IN THE OUTER HANDLE. A POSSIBLE CAUSE OF THE NEEDLE KINKING IN THE OUTER HANDLE CANNOT BE CONCLUSIVELY DETERMINED. HOWEVER IT IS POSSIBLE THAT SIGNIFICANT FORCE DURING THE INITIAL NEEDLE ADVANCEMENT MAY HAVE RESULTED IN THE NEEDLE KINKING. AS THE CONDITIONS OF USE CANNOT BE REPLICATED DURING THE LABORATORY EVALUATION IT IS NOT POSSIBLE TO CONCLUSIVELY STATE THE CAUSE OF THIS COMPLAINT. PRIOR TO DISTRIBUTION, ALL ECHO DEVICES ARE SUBJECTED TO FUNCTIONAL CHECKS AND VISUAL INSPECTION TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE RELEVANT MANUFACTURING RECORDS FOR THIS ECHO DEVICE DID NOT REVEAL ANY DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. NO CORRECTIVE ACTION IS WARRANTED AT THIS TIME. THIS EVENT DID NOT IMPACT THE PATIENT OR USER. THE 2 YEAR COMPLAINT HISTORY HAS BEEN REVIEWED FOR THIS SPECIFIC RPN AND THE LIKELIHOOD OF THIS TYPE OF OCCURRENCE IS LOW. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 1

    INITIAL INFORMATION RECEIVED STATED THAT AT THE FIRST USE THE NEEDLE DID NOT EXIT FROM THE SHEATH. THE DOCTOR TRIED TO REMOVE THE NEEDLE FROM THE ECHO ENDOSCOPE BUT THE NEEDLE WAS BLOCKED. HE FINALLY SUCCEEDED TO REMOVE IT WHEN IT BROKE AT THE PROXIMAL PART. THIS COMPLAINT DESCRIPTION WAS CLARIFIED AS MEANING THE PROXIMAL HANDLE BROKE. HOWEVER THE RETURNED ECHO DEVICE WAS EVALUATED ON THE (B)(6) 2013 AND IT WAS CONFIRMED THAT THE NEEDLE WAS BROKEN. THIS NEEDLE BREAKAGE MAY HAVE BEEN DIFFICULT TO VISUALIZE BY THE USER DUE TO THE STYLET HOLDING THE NEEDLE IN PLACE. 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 DUE TO THIS OCCURRENCE - UNDER STUDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144524 ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE FCG KIT, NEEDLE, BIOPSY FCG COOK IRELAND LTD C813573

    Patients

    Seq Age Sex Outcome Treatment
    1