BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE

    MDR report key: 3070246 · Received April 16, 2013

    Report

    Report Number
    3001845648-2013-00034
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Report Date
    March 21, 2013
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FCG
    PMA / PMN Number
    K083330
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFO PROVIDED INDICATED THE DEVICE INVOLVED IN THIS COMPLAINT TO BE AN ECHO-HD-19-C (ECHO) DEVICE. THE LOT NUMBER WAS NOT PROVIDED, THEREFORE, IT WAS NOT POSSIBLE TO CHECK IF ANY OF THE AFFECTED LOT REMAINED IN STOCK. THE ECHO DEVICE INVOLVED IN THIS COMPLAINT WAS NOT RETURNED FOR EVAL. THEREFORE, THE CUSTOMER'S COMPLAINT REMAINS UNCONFIRMED. WITH THE INFO PROVIDED A DOCUMENT BASED INVESTIGATION WAS CARRIED OUT. INFO PROVIDED BY THE USER INDICATED THE TIP OF THE NEEDLE OF THIS ECHO DEVICE BROKE. FURTHER INFO RECEIVED INDICATED THE USER WAS USING THIS DEVICE WITHOUT THE STYLET IN PLACE. AS PER THE INSTRUCTIONS FOR USE FOR THIS DEVICE, IFU0077-2, THE USER IS CAUTIONED AS FOLLOWS: "ENSURE THE STYLET IS FULLY INSERTED WHEN ADVANCING THE NEEDLE INTO THE BIOPSY SITE." A POSSIBLE CAUSE OF THE USER REPORTED ISSUE OF A BROKEN NEEDLE MAY BE ATTRIBUTED TO THE STYLET NOT BEING IN PLACE WHILE ADVANCING THE NEEDLE INTO THE BIOPSY SITE. HOWEVER AS THE ECHO DEVICE INVOLVED IN THIS COMPLAINT WAS NOT RETURNED FOR EVAL, IT IS NOT POSSIBLE TO CONCLUSIVELY STATE THE ROOT CAUSE OF THIS COMPLAINT. THE INFO RECEIVED IN RELATION TO THIS COMPLAINT INDICATED A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY, THE PATIENT DID NOT REQUIRE ANY ADD'L PROCEDURES DUE TO THIS OCCURRENCE AND THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. PRIOR DISTRIBUTION, ALL ECHO DEVICES ARE SUBJECTED TO FUNCTIONAL CHECKS AND VISUAL INSPECTION TO ENSURE DEVICE INTEGRITY. THE LOT NUMBER OF THE ECHO DEVICE INVOLVED IN THIS COMPLAINT WAS NOT PROVIDED. THEREFORE, IT WAS NOT POSSIBLE TO CONDUCT A REVIEW OF THE RELEVANT MFG RECORDS. NO CORRECTIVE ACTION IS WARRANTED AT THIS TIME. THIS EVENT DID NOT IMPACT THE PATIENT OR USER. 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

    AFTER THE BIOPSY OF A CHRONIC PANCREATITIS, IT HAD BEEN NOTICED THAT THE TIP OF THE ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE BROKE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163105 ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE FCG KIT, NEEDLE, BIOPSY FCG COOK IRELAND LTD UNK

    Patients

    Seq Age Sex Outcome Treatment
    1