BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE

    MDR report key: 3697669 · Received January 8, 2014

    Report

    Report Number
    3001845648-2014-00001
    Event Type
    Malfunction
    Date Received
    January 8, 2014
    Date of Event
    December 13, 2013
    Report Date
    December 13, 2013
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FCG
    PMA / PMN Number
    K934356
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    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 PT OUTCOME. THE COMPLAINT INFO PROVIDED WAS AS FOLLOWS: "THE PHYSICIAN COMPLETED THE FIRST PASS. WHEN EXPELLING THE SPECIMEN ON THE SLIDE NOTHING WOULD COME OUT. ATTEMPTED TO CLEAN THE DEVICE AND WHEN SALINE WAS INTRODUCED, A STREAM OF SALINE CAME OUT OF THE SIDE OF THE NEEDLE BY THE HANDLE. THE PHYSICIAN WAS NOT ABLE TO EXPEL THE SAMPLE BUT OPENED ANOTHER OF THE SAME DEVICE TO COMPLETE THE PROCEDURE." THERE WERE NO ECHO-25 (ECHO) DEVICES OF LOT # C914495 IN STOCK AT THE TIME OF THE COMPLAINT INVESTIGATION. THE ECHO DEVICE INVOLVED IN THIS COMPLAINT HAS NOT BEEN REC'D FOR EVAL. THEREFORE THE CUSTOMER'S COMPLAINT REMAINS CONFIRMED. WITH THE INFO PROVIDED A DOCUMENT BASED INVESTIGATION WAS CARRIED OUT. FROM THE COMPLAINT INFO PROVIDED, IT IS ASSUMED THE CUSTOMER IS REPORTING A NEEDLE BREAKAGE WITHIN THE HANDLE OF THE ECHO DEVICE. A NEEDLE BREAKAGE WITHIN THE HANDLE WOULD ALSO ACCOUNT FOR THE SALINE LEAKING FROM THE HANDLE. A POSSIBLE CAUSE OF THIS COMPLAINT MAY BE DUE TO THE NEEDLE KINKING IN THE HANDLE. AS THE NEEDLE WAS ADVANCED/RETRACTED THIS KINK MAY HAVE RESULTED IN A NEEDLE BREAKAGE. HOWEVER, AS THE ECHO DEVICE INVOLVED IN THIS COMPLAINT WAS NOT RETURNED FOR EVAL IT IS NOT POSSIBLE TO DEFINITIVELY STATE IF THIS IS THE ROOT CAUSE OF THIS COMPLAINT. IT MAY BE NOTED THAT THIS SPECIFIC ISSUE [NEEDLE KINKING IN THE HANDLE] IS CURRENTLY BEING ADDRESSED. THE COMPLAINT INFO REC'D INDICATED THAT NO PART OF THE NEEDLE BROKE INSIDE OF THE PT. NO ADVERSE EFFECTS TO THE PT WERE REPORTED AS A RESULT OF THIS OCCURRENCE. PRIOR TO DISTRIBUTION, ALL ECHO DEVICES ARE SUBJECTED TO FUNCTIONAL CHECKS AND VISUAL INSPECTION TO ENSURE DEVICE INTEGRITY. A REVIEW OF MFG RECORDS FOR ECHO DEVICES OF LOT NUMBER SPECIFIED ABOVE DID NOT REVEAL ANY DISCREPANCIES RELATED TO THE COMPLAINT ISSUE. NO CORRECTIVE ACTION IS WARRANTED AT THIS TIME. THIS EVENT DID NOT IMPACT THE PT OR USER. A HEALTH RISK ASSESSMENT WAS CARRIED OUT TO ASSESS THE RISK OF NEEDLE BREAKAGE ACROSS THE ECHO PRODUCT FAMILY AND WAS DETERMINED TO BE LOW RISK. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 1

    THE PHYSICIAN COMPLETED THE FIRST PASS. WHEN EXPELLING THE SPECIMEN ON THE SLIDE NOTHING WOULD COME OUT. THE PHYSICIAN ATTEMPTED TO CLEAN THE DEVICE AND WHEN SALINE WAS INTRODUCED, A STREAM OF SALINE CAME OUT OF THE SIDE OF THE NEEDLE BY THE HANDLE. THE PHYSICIAN WAS NOT ABLE TO EXPEL THE SAMPLE BUT OPEN ANOTHER OF THE SAME DEVICE TO COMPLETE THE PROCEDURE. FROM THIS PROVIDED INFO IT IS REASONABLE TO ASSUME THAT THIS COMPLAINT REPORT MAY INVOLVE A PROXIMAL NEEDLE BREAKAGE AS THE SALINE IS FLUSHED THROUGH THE NEEDLE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PT'S BODY. THE PT DID NOT REQUIRE ANY ADD'L PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL RPTR, THE PT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    14997 ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE FCG KIT, NEEDLE, BIOPSY FCG COOK IRELAND LTD C914495

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK