BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE

    MDR report key: 9727392 · Received February 19, 2020

    Report

    Report Number
    3001845648-2020-00101
    Event Type
    Injury
    Date Received
    February 19, 2020
    Date of Event
    January 22, 2020
    Report Date
    March 9, 2020
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FCG
    UDI-DI
    10827002347851
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) # K142688. 9 UNITS OF LOT NUMBER C1665760 OF ECHO-HD-3-20-C WERE RETURNED UN-OPENED IN THEIR ORIGINAL PACKAGING. 1 UNIT OF LOT NUMBER C1665760 OF ECHO-HD-3-20-C WAS RETURNED OPENED IN ITS ORIGINAL PACKAGING. THE DEVICE RELATED TO THIS OCCURRENCE UNDERWENT A LABORATORY EVALUATION. THE NEEDLE WAS FOUND TO BE BROKEN DISTALLY. PRIOR TO DISTRIBUTION, ALL ECHO-HD-3-20-C DEVICES ARE SUBJECTED TO FUNCTIONAL CHECKS AND VISUAL INSPECTION TO ENSURE DEVICE INTEGRITY. THESE INSPECTIONS AND FUNCTIONAL CHECKS ARE OUTLINED IN INTERNAL PROCEDURES IN PLACE AT CIRL. A REVIEW OF THE MANUFACTURING RECORDS FOR ECHO-HD-3-20-C OF LOT NUMBER C1665760 DID NOT REVEAL ANY DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. THE REVIEW OF RELEVANT MANUFACTURING RECORDS, CONFIRMS THE FAILURE MODE HAS NOT PREVIOUSLY OCCURRED WITH THE CURRENT LOT NUMBER. BASED ON THE INFORMATION AVAILABLE TO DATE, THERE IS NO EVIDENCE TO SUGGEST THAT THERE ARE ANY MANUFACTURING ISSUES ASSOCIATED WITH LOT NUMBER C1665760. THE NOTES SECTION OF THE INSTRUCTIONS FOR USE, WHICH ACCOMPANIES THIS DEVICE INSTRUCTS THE USER TO INSPECT THE DEVICE PRIOR TO USE : "VISUALLY INSPECT WITH PARTICULAR ATTENTION TO KINKS, BENDS AND BREAKS. IF AN ABNORMALITY IS DETECTED THAT WOULD PROHIBIT PROPER WORKING CONDITION, DO NOT USE". THERE IS NO EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. A POSSIBLE CAUSE COULD BE ATTRIBUTED TO HARD LESION AS INDICATED IN THE ADDITIONAL INFORMATION. COMPLAINT IS CONFIRMED AS THE FAILURE WAS VERIFIED IN THE LABORATORY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. ON CT SCAN THE LOCATION OF THE NEEDLE TIP CAN BE SEEN IN THE PANCREAS. A SECOND FRAGMENT CAN ALSO BE SEEN IN THE BOWEL 2 HOURS POST PROCEDURE. PATIENT HAS HAD TO BE ADMITTED INTO HOSPITAL FOR CLOSE OBSERVATIONS. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    NEEDLE TIP BROKE OFF IN PANCREATIC LESION. AS PER COMPLAINT FORM:"ON THE SECOND PASS THE NEEDLE TIP BROKE OFF IN PANCREATIC LESION IN BODY OF PANCREAS."

    Additional Manufacturer Narrative · 1

    PMA/510(K) # K142688. INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Description of Event or Problem · 1

    NEEDLE TIP BROKE OFF IN PANCREATIC LESION. AS PER COMPLAINT FORM:"ON THE SECOND PASS THE NEEDLE TIP BROKE OFF IN PANCREATIC LESION IN BODY OF PANCREAS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193812 ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE FCG KIT, NEEDLE, BIOPSY FCG COOK IRELAND LTD C1665760 10827002347851

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R