BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE

    MDR report key: 3140187 · Received May 29, 2013

    Report

    Report Number
    3001845648-2013-00049
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    April 12, 2013
    Report Date
    May 8, 2013
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FCG
    PMA / PMN Number
    K934356
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER COMPLAINT ISSUE WAS REPORTED AS FOLLOWS: "DYSFUNCTION OF THE NEEDLE DURING THE PROCEDURE, THEY COULDN'T PLACE THE NEEDLE INTO THE SHEATH ANYMORE." THERE WERE NO ECHO-1-22 (ECHO) DEVICES OF LOT # C856031 IN STOCK AT THE TIME OF THE COMPLAINT INVESTIGATION. THE 1 X ECHO DEVICE OF LOT # C856031 WAS RETURNED FOR EVAL. THE DEVICE WAS RETURNED IN THE ORIGINAL PACKAGE AND WAS OPEN ON RECEIPT. UPON EVAL OF THIS ECHO DEVICE THE OUTER HANDLE WOULD NOT ADVANCE PAST THE "5 1/2" MARKER; THEREFORE, THE NEEDLE COULD NOT BE FULLY ADVANCED. THE DISTAL NEEDLE TIP WAS VISIBLE AT THE SHEATH TIP AND WAS CONFIRMED INTACT. THE NEEDLE WAS REMOVED FROM THE DEVICE AND WAS CONFIRMED TO BE BROKEN. THE NEEDLE OF THIS DEVICE BROKE APPROX 21.5CM FROM THE PROXIMAL TIP OF THE NEEDLE WHICH CORRESPONDS TO A BREAKAGE AT THE BASE OF THE INNER HANDLE. IT MAY BE NOTED THAT NO INFO WAS RECEIVED PRIOR TO THIS EVAL THAT INDICATED THIS COMPLAINT INVOLVED A BROKEN NEEDLE. A POSSIBLE CAUSE OF THIS NEEDLE BREAKAGE MAY BE DUE TO A KINK WITHIN THE INNER HANDLE WHICH RESULTED IN A BREAKAGE FOLLOWING THE ADVANCEMENT OR RETRACTION OF THE NEEDLE. IT IS MOST LIKELY THIS KINK OCCURRED DURING THE USE OF THIS DEVICE. A POSSIBLE CAUSE OF THE NEEDLE KINKING WITHIN THE HANDLE MAY BE DUE TO PT ANATOMY IF THE LESION BEING PUNCTURED WAS A HARD LESION AND REQUIRED A PARTICULARLY FORCEFULLY ADVANCEMENT OF THE NEEDLE. THE COMPLAINT INFO RECEIVED CONFIRMED THE AREA BEING SAMPLED WAS A PANCREATIC TUMOR. AS THE CONDITION OF USE CANNOT BE REPLICATED DURING THE LAB EVAL IT IS NOT POSSIBLE TO DEFINITIVELY STATE A ROOT CAUSE OF THIS COMPLAINT. THE COMPLAINT INFO RECEIVED CONFIRMED NO SECTION OF THE DEVICE DETACHED INSIDE THE PT. THE PT INVOLVED DID NOT REQUIRE ANY ADD'L PROCEDURES AND NO ADVERSE EFFECTS WERE REPORTED TO THE PT AS A RESULT OF THIS INCIDENT. ALL PARTS OF THE NEEDLE WERE ACCOUNTED FOR DURING THE LAB EVAL AND THE DISTAL TIP OF THE NEEDLE WAS CONFIRMED INTACT. 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 ECHO DEVICE DID NOT REVEAL ANY DISCREPANCIES WHICH COULD HAVE CONTRIBUTED TO THE COMPLAINT ISSUE. NO CORRECTIVE ACTION IS WARRANTED AT THIS TIME. THIS EVENT DID NOT IMPACT THE PT OR USER. 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 REPORTER, THE PT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. THE 2 YEAR COMPLAINT HISTORY HAS BEEN REVIEWED FOR THIS 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

    DYSFUNCTION OF THE NEEDLE DURING THE PROCEDURE, THEY COULD NOT RETRACT THE NEEDLE INTO THE SHEATH ANYMORE. LAB EVAL CONDUCTED ON THE (B)(6) 2013, CONFIRMED THE NEEDLE WAS BROKEN. 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 REPORTER, THE PT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236225 ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE FCG KIT, NEEDLE, BIOPSY FCG COOK IRELAND LTD C856031

    Patients

    Seq Age Sex Outcome Treatment
    1