BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE

    MDR report key: 14013030 · Received April 5, 2022

    Report

    Report Number
    3001845648-2022-00198
    Event Type
    Malfunction
    Date Received
    April 5, 2022
    Date of Event
    March 4, 2022
    Report Date
    July 11, 2022
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FCG
    UDI-DI
    10827002557366
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    PMA/510(K) # K142688. 1 UNIT OF LOT C1881454 OF ECHO-HD-22-C WAS RETURNED OPENED IN ITS ORIGINAL PACKAGING. THE DEVICE INVOLVED IN THIS COMPLAINT WAS EVALUATED IN THE LABORATORY . THE RETURNED DEVICE LAB FINDINGS AND OBSERVATIONS CAN BE REFERRED THROUGH THE ATTACHED FILES. THE DISTAL END OF THE NEEDLE WAS OBSERVED TO BE BROKEN. PRIOR TO DISTRIBUTION, ALL ECHO-HD-22-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-22-C OF LOT NUMBER C1881454 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 C1881454 . 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 FOR THE CUSTOMER COMPLAINT COULD NOT BE DETERMINED AS CIRCUMSTANCES OF USE CANNOT BE REPLICATED IN THE LABORATORY. A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO THE ACTUAL LESION WAS HARD LEADING TO THE DISTAL END OF THE NEEDLE TO BREAK. 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. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    USER DETECTED THERE WAS OBVIOUS RESISTANCE DURING FIRST ATTEMPT, THEN RETRACTED THE NEEDLE FROM PATIENT AND FOUND OUT THE NEEDLE TIP BROKEN. USER THEN CHANGED TO ANOTHER SAME DEVICE TO COMPLETE THE BIOPSY. 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.

    Description of Event or Problem · 0

    SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE RETURN AND EVALUATION OF THE COMPLAINT DEVICE. THE INVESTIGATION WAS CONCLUDED ON THE 29-JUL-2021, THIS SUPPLEMENT REPORT WILL ALSO INCLUDE THE INVESTIGATION CONCLUSIONS. EVALUATION OF THE COMPLAINT DEVICE ON 11-JUL-2022: VISUAL INSPECTION: - DISTAL END OF NEEDLE EXAMINED AND DISTAL BREAK APPROXIMATELY 7.1CM FROM TIP OF THE SHEATH. FUNCTIONAL INSPECTION: - SHEATH EXTENDER ABLE TO ADVANCE AND RETRACT WITH NO ISSUE - NEEDLE ABLE TO ADVANCE AND RETRACT WITH NO ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94761 ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE FCG KIT, NEEDLE, BIOPSY FCG COOK IRELAND LTD C1881454 10827002557366

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male