BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE

    MDR report key: 3140009 · Received May 28, 2013

    Report

    Report Number
    3001845648-2013-00047
    Event Type
    Malfunction
    Date Received
    May 28, 2013
    Date of Event
    April 16, 2013
    Report Date
    May 15, 2013
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FCG
    PMA / PMN Number
    K083330
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S COMPLAINT ISSUE WAS CONFIRMED AS FOLLOWS: "THE PHYSICIAN MADE THE FIRST PASS WITHOUT DIFFICULTY. UPON THE SECOND PASS, THE NEEDLE WOULD NOT FUNCTION CORRECTLY LIKE IT DISENGAGED FROM THE HANDLE. EVERYTHING, NEEDLE AND SCOPE, WERE REMOVED FROM THE PT. THE NEEDLE TIP WAS NOTED TO STILL BE OUT." CLARIFICATION RECEIVED ON THIS COMPLAINT DESCRIPTION INDICATED THIS COMPLAINT REPORT DID NOT INVOLVE A BROKEN NEEDLE. HOWEVER, THE NEEDLE WAS CONFIRMED BROKEN AT A LATER DATE DURING THE LABORATORY EVALUATION. THERE WERE NO ECHO-HD-19-C (ECHO) DEVICE OF LOT #C846699 IN STOCK AT THE TIME OF THE COMPLAINT INVESTIGATION. THE 1 X ECHO DEVICE OF LOT C846699 WAS RETURNED FOR EVAL. THE DEVICE WAS NOT RETURNED IN THE ORIGINAL PACKAGING. THE ORIGINAL LABEL WAS RETURNED WITH THE ECHO DEVICE. IT WAS NOTED THAT THIS ECHO DEVICE WAS RETURNED IN EXTREMELY BAD CONDITION. THE SHEATH AND NEEDLE OF THIS ECHO DEVICE WERE SEVERELY KINKED AND DISTORTED AT NUMEROUS LOCATIONS THAT MEASUREMENTS WERE NOT POSSIBLE TO TAKE. IT WAS NOTED DURING THE EVAL THAT THE CONDITION OF THE RETURNED ECHO DEVICE INDICATED SIGNIFICANT MISHANDLING OF THE PRODUCT. THIS ECHO DEVICE WAS RECEIVED WITH APPROX 3.5CM OF THE NEEDLE EXPOSED. IT WAS NOT POSSIBLE TO ADVANCE/RETRACT THE NEEDLE. THE NEEDLE TIP WAS EXAMINED AND CONFIRMED INTACT. A SIGNIFICANT SHAPE SET WAS NOTED TO THE NEEDLE EXTENSION AND DISTAL END OF THE SHEATH INDICATING THIS DEVICE HAD BEEN USED. THE MULTIPLE KINKS AND BENDS NOTED WITH THE SHEATH/NEEDLE WERE VISUALLY EXAMINED. THE NEEDLE WAS CONFIRMED BROKEN APPROX 6.5 CM FROM THE SHEATH EXTENDER. THIS BREAKAGE WOULD ACCOUNT FOR THE INABILITY TO ADVANCE/RETRACT THE NEEDLE DURING THE EVAL. A POSSIBLE CAUSE FOR THIS NEEDLE BREAKAGE MAY BE ATTRIBUTED TO THE NEEDLE KINKING BELOW THE SHEATH EXTENDER. THIS KINK MAY HAVE OCCURRED DUE TO PRODUCT HANDLING WHEN REMOVING THE DEVICE FROM THE PACKAGING OR DURING DEVICE INTRODUCTION/REMOVAL FROM THE ENDOSCOPE. IF THE HANDLE OF THE ECHO DEVICE IS NOT APPROPRIATELY HANDLED IT IS POSSIBLE FOR THE SHEATH TO BECOME KINKED DUE TO THE WEIGHT OF THE HANDLE. AS THE NEEDLE WAS ADVANCE/RETRACTED OR DUE TO THE HANDLING OF THE DEVICE DURING THE PROCEDURE IT IS POSSIBLE THIS KINK RESULTED IN A BREAKAGE. AS STATED PREVIOUSLY THIS ECHO DEVICE WAS RECEIVED IN EXTREMELY BAD CONDITION. MULTIPLE BENDS AND KINKS WERE NOTED TO THE SHEATH/NEEDLE. A CAUSE FOR THIS DAMAGE MAY BE ATTRIBUTED TO SIGNIFICANT MISHANDLING OF THE DEVICE DURING USE. THE MANNER IN WHICH THE DEVICE WAS PACKAGED FOR RETURN MAY ALSO HAVE CONTRIBUTED TO THE CONDITION OF THE RETURNED ECHO DEVICE. AS THE CONDITIONS OF USE CANNOT BE REPLICATED DURING THE LABORATORY EVAL IT IS NOT POSSIBLE TO CONCLUSIVELY DETERMINE THE ROOT CAUSE OF THIS COMPLAINT. INFO RECEIVED CONFIRMED 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 AND THE PT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. ALL PARTS OF THE NEEDLE WAS ACCOUNTED FOR DURING A LABORATORY EVAL. 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 ADDITIONAL 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 IN LOW. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR PT EMERGING TRENDS.

    Description of Event or Problem · 1

    THE PHYSICIAN MADE THE FIRST PASS WITHOUT DIFFICULTY. UPON THE SECOND PASS, THE NEEDLE WOULD NOT FUNCTION CORRECTLY LIKE IT DISENGAGED FROM THE HANDLE. EVERYTHING, NEEDLE AND SCOPE, WERE REMOVED FROM THE PT. THE NEEDLE TIP WAS NOTED TO STILL BE OUT. A DIFFERENT NEEDLE WAS USED TO COMPLETE THE PROCEDURE WITHOUT DIFFICULTY. 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
    233041 ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE FCG KIT, NEEDLE, BIOPSY FCG COOK IRELAND LTD C846699

    Patients

    Seq Age Sex Outcome Treatment
    1