BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHOTIP PROCORE HD ENDORONCHIAL BIOPSY NEEDLE

    MDR report key: 3805412 · Received April 30, 2014

    Report

    Report Number
    3001845648-2014-00075
    Event Type
    Injury
    Date Received
    April 30, 2014
    Date of Event
    April 4, 2014
    Report Date
    April 4, 2014
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FCG
    PMA / PMN Number
    K093195
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WERE NO ECHO-HD-25-EBUS-O-C (ECHO) DEVICES OF LOT #C951585 IN STOCK AT THE TIME OF THE COMPLAINT INVESTIGATION. THE ECHO DEVICE INVOLVED IN THIS COMPLAINT WAS NOT RETURNED FOR EVALUATION. WITH THE INFO PROVIDED A DOCUMENT BASED INVESTIGATION WAS CARRIED OUT. THE COMPLAINT INFO REPORTED THAT THE PHYSICIAN HAD DIFFICULTY PENETRATING THE LESION. A POSSIBLE CAUSE OF NEEDLE BREAKAGE IN THIS INCIDENT MAY BE ATTRIBUTED TO THE PT'S ANATOMY AS THE LESION BEING PUNCTURED WAS A HARD LESION AND REQUIRED A PARTICULARLY FORCEFUL ADVANCEMENT OF THE NEEDLE. AS THE DEVICE WAS NOT RETURNED FOR EVALUATION AND CONDITIONS OF DEVICE USAGE CANNOT BE REPLICATED INT HE LABORATORY IT IS NOT POSSIBLE TO DEFINITIVELY STATE IF THIS IS THE ROOT CAUSE OF THIS COMPLAINT. THE CUSTOMER COMPLAINT WAS CONFIRMED BASED ON CUSTOMER TESTIMONY. PRIOR TO DISTRIBUTION, ALL ECHO DEVICES ARE SUBJECTED TO FUNCTIONAL CHECKS AND VISUAL INSPECTION TO ENSURE INTEGRITY OF THE PRODUCT. THESE INSPECTIONS AND FUNCTIONAL CHECKS ARE OUTLINED IN THE PROCEDURES REFERENCE ABOVE AND ATTACHED. THE NOTES SECTION OF THE INSTRUCTIONS FOR USE IFU0109-1 THAT ACCOMPANIES THIS DEVICE INSTRUCTS THE USER TO "VISUALLY INSPECT WITH PARTICULAR ATTENTION TO KINKS, BENDS AND BREAKS. IF ANY ABNORMALITY IS DETECTED THAT WOULD PROHIBIT PROPER WORKING CONDITION, DO NOT USE". A FORCEPS WERE USED TO RETRIEVE THE NEEDLE PIECE FROM THE PT. ONCE THE ET TUBE WAS REMOVED, THE NEEDLE WAS FOUND STUCK INSIDE. IT WAS CONFIRMED THAT NO PART OF THE NEEDLE REMAINED IN THE PT. NO FURTHER ADVERSE EFFECTS TO THE PT WERE REPORTED AS A RESULT OF THIS OCCURRENCE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 1

    THE COMPLAINT INFO RECEIVED INDICATED THE PHYSICIAN EXPERIENCED DIFFICULTY WHEN PUNCTURING THE LESION. AFER A FEW "JABS" AT THE LESION, THE NEEDLE PUNCTURED THE LESION. AFTER REMOVAL OF THE NEEDLE FROM THE LESION, IT WAS NOTED THAT A PIECE OF THE NEEDLE HAD BROKEN OFF. A FORCEPS WAS USED TO RETRIEVE THE BROKEN NEEDLE PIECE FROM THE PT. THE NEEDLE PIECE WAS LOST WHILE TRYING TO REMOVE THE NEEDLE WITH THE FORCEPS. ONCE THE ET TUBE WAS REMOVED, THE NEEDLE WAS FOUND STUCK INSIDE. NO PORTION OF THE DEVICE REMAINS INSIDE THE PT. NO FURTHER ADVERSE EFFECTS TO THE PT REPORTED AS OCCURRING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258636 ECHOTIP PROCORE HD ENDORONCHIAL BIOPSY NEEDLE FCG KIT, NEEDLE, BIOPSY FCG COOK IRELAND LTD C951585

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention