BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE

    MDR report key: 3396737 · Received September 18, 2013

    Report

    Report Number
    3001845648-2013-00102
    Event Type
    Malfunction
    Date Received
    September 18, 2013
    Date of Event
    August 13, 2013
    Report Date
    August 20, 2013
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FCG
    PMA / PMN Number
    K934356
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    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 ((B)(4)). 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 THE OUTCOME. IT IS ASSUMED THE OBSERVATION OF A 'CRACKING' NOISE IS A NEEDLE BREAKAGE OCCURRING IN THE HANDLE OF THE ECHO DEVICE. ADD'L INFO REC'D INDICATED THIS SPECIFIC INCIDENT OCCURRED PRIOR TO PT CONTACT. THERE WERE NO ECHO-25 (ECHO) DEVICES OF LOT # C881742 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 CUSTOMERS' COMPLAINT REMAINS UNCONFIRMED. WITH THE INFO PROVIDED A DOCUMENT BASED ON INVESTIGATION WAS CARRIED OUT. A POSSIBLE CAUSE OF THE REPORTED DIFFICULTIES WITH THE ADVANCEMENT/RETRACTION OF THE NEEDLE AND THE REPORTED NEEDLE BREAKAGE IN THE HANDLE MAY BE DUE TO THE NEEDLE KINKING IN THE HANDLE. 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 ISSUE [NEEDLE KINKING IN HANDLE] HAS BEEN INVESTIGATED IN-HOUSE AND A DEVIATION WAS APPROVED TO INTRODUCE A CANNULA PUSHER TOOL WHICH HAS AN END STOP TO PREVENT THE CANNULA BEING PUSHED IN TOO FAR. THE CANNULA HAD THE POTENTIAL TO BE PUSHED IN TOO FAR LEADING TO RESISTANCE IN THE ACTIVATION OF THE HANDLE. THIS NEW TOOL WILL PREVENT THE OVER INSERTION OF THE CANNULA REDUCING OCCURRENCES OF THE NEEDLE KINKING IN THE DISTAL END OF THE HANDLE. THE ECHO DEVICE INVOLVED IN THIS COMPLAINT WAS MANUFACTURED PRIOR TO THE APPROVAL OF THIS DEVIATION. A PROJECT HAS ALSO OPENED TO ADDRESS THIS SPECIFIC ISSUE [NEEDLE KINKING IN THE PROXIMAL END OF THE HANDLE]. THE COMPLAINT INFO REC'D INDICATED THAT NO PART OF THE NEEDLE BROKE INSIDE OF THE PT. THIS INCIDENT OCCURRED PRIOR TO PT CONTACT. 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 THE RELEVANT MFG RECORDS FOR THIS DEVICE DID NOT REVEAL A DISCREPANCY WHICH COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. NO CORRECTIVE ACTION IS WARRANTED AT THIS TIME. THIS EVENT DID NOT IMPACT THE PT OR USER. THIS INCIDENT PRIOR TO PT CONTACT. NO PART OF THE NEEDLE BROKE INSIDE THE PT. THE 2 YR COMPLAINT HISTORY HAS BEEN REVIEWED FOR THIS RPN AND THE LIKELIHOOD OF THIS TYPE OF OCCURRENCE IS LOW. 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.

    Description of Event or Problem · 1

    THE PHYSICIAN IS EXPERIENCING DIFFICULTY IN REMOVING THE ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLES FROM THE SHEATH. THE SLIDING IS VERY ROUGH AND IF THE NEEDLE IS ABLE TO BE REMOVED THE PHYSICIAN HEARS A "CRACK" AS IF THE MECHANISM JUST BROKE. DIFFICULTY WITH RETRACTION OF THE NEEDLE ALSO REPORTED. FROM THE PROVIDED INFO THE 'CRACKING' NOISE OBSERVED BY USER IS ASSUMED TO BE A NEEDLE BREAKAGE WITHIN THE HANDLE. THIS INCIDENT OCCURRED PRIOR TO PT CONTACT. 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
    469795 ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE FCG KIT, NEEDLE, BIOPSY FCG COOK IRELAND LTD C881742

    Patients

    Seq Age Sex Outcome Treatment
    1