BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHOTIP PROCARE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE

    MDR report key: 2906825 · Received January 4, 2013

    Report

    Report Number
    3001845648-2013-00002
    Event Type
    Malfunction
    Date Received
    January 4, 2013
    Date of Event
    December 11, 2012
    Report Date
    December 20, 2012
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FCG
    PMA / PMN Number
    K083330
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WERE NO ECHO DEVICES OF LOT C771465 IN STOCK AT THE TIME OF THE INVESTIGATION; 1X ECHO DEVICE OF LOT C771465 WAS RETURNED FOR EVAL. IT WAS RETURNED IN ITS ORIGINAL PACKAGING AND WAS OPEN ON RECEIPT. THE COMPLAINT INFO STATED THAT USER OF THE DEVICE HAD THE FOLLOWING ISSUE ¿WHILE REPLACING THE STYLET IN THE SHEATH, THE NEEDLE IS COMING OUT OF THE SHEATH. IT¿S NOT POSSIBLE TO PUSH THE STYLET IN THE NEEDLE.¿ NEEDLE BREAKAGE WAS NOT REPORTED. HOWEVER, ON EVAL OF THE RETURNED DEVICE, IT WAS NOTED THAT THE NEEDLE HAD BROKEN AWAY FROM THE DEVICE WITHIN ITS SHEATH BELOW THE SHEATH EXTENDER. THE REMAINING PIECE OF THE NEEDLE RETURNED ATTACHED TO THE DEVICE. THERE WAS NO PART OF THE NEEDLE MISSING. THE STYLET AND CAP WAS RETURNED SEPARATE TO THE DEVICE. THE NEEDLE TIP AND NOTCH WAS INTACT. THE STYLET COULD ADVANCE AND RETRACT WITHIN THE DEVICE. THE SHEATH AT THE DISTAL END WAS INTACT. DESPITE NUMEROUS ATTEMPTS REQUESTING INFO AS TO HOW THE NEEDLE BROKE, NO FURTHER DETAILS HAVE BEEN RECEIVED AND THEREFORE IT IS UNK AS TO HOW THE NEEDLE AND SHEATH DETACHED FROM THE DEVICE. THE CUSTOMER COMPLAINT ISSUE COULD NOT CONFIRM AS THE NEEDLE WAS RETURNED BROKEN AWAY FROM THE DEVICE AND COULD NOT FUNCTION AS INTENDED DUE TO THE BREAKAGE. A POSSIBLE CAUSE OF THE COMPLAINT COULD BE THAT THE DEVICE MAY HAVE BEEN DAMAGED DURING ITS INTRODUCTION INTO THE ENDOSCOPE OR DURING USE. FROM THE INFO PROVIDED THE ENDOSCOPE WAS IN A FLEXED OR TWISTED POSITION DURING THE PROCEDURE. AS THE ENDOSCOPE WAS BEING USED IN A FLEXED OR TWISTED POSITION THEN THIS MAY HAVE CAUSED THE NEEDLE TO KINK AND BREAK BELOW THE SHEATH EXTENDER. HOWEVER, NO KINK OR BEND WAS REPORTED AS PER THE INFO PROVIDED. PRIOR TO DISTRIBUTION, ALL ECHO DEVICES ARE SUBJECTED TO FUNCTIONAL CHECKS AND VISUAL INSPECTION TO ENSURE INTEGRITY OF THE PRODUCT. A REVIEW OF THE MFG RECORDS FOR ECHO DEVICE OF LOT NUMBER C771465 DID NOT REVEAL ANY DISCREPANCIES WHICH COULD HAVE CONTRIBUTED TO THE COMPLAINT REPORT THE (B)(4) COMPLAINT HISTORY HAS BEEN REVIEWED AND THIS TYPE OF COMPLAINT ¿NEEDLE BREAKAGE¿ OCCURRENCE IS LOW. NO CORRECTIVE ACTION IS WARRANTED AT THIS TIME. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 1

    WHILE REPLACING THE STYLET IN THE SHEATH, THE NEEDLE IS COMING OUT OF THE SHEATH. IT¿S NOT POSSIBLE TO PUSH THE STYLET IN THE NEEDLE. THE NEEDLE WAS BROKEN ON RETURN OF THE DEVICE FOR EVAL. NO SECTION OF THE DEVICE REMAINED IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5304 ECHOTIP PROCARE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE KIT, NEEDLE, BIOPSY FCG COOK IRELAND LTD C771465

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK