BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE

    MDR report key: 14117053 · Received April 15, 2022

    Report

    Report Number
    3001845648-2022-00229
    Event Type
    Malfunction
    Date Received
    April 15, 2022
    Report Date
    July 15, 2022
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FCG
    UDI-DI
    10827002347851
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) #K146288. INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Additional Manufacturer Narrative · 0

    PMA/510(K) #K210476. DEVICE EVALUATION: 1 UNIT OF LOT C1872367 OF ECHO-HD-3-20-C WAS RETURNED OPENED IN ITS ORIGINAL PACKAGING. LAB EVALUATION: THE DEVICE INVOLVED IN THE COMPLAINT WAS EVALUATED IN THE LABORATORY ON 04 APRIL 2022. THE RETURNED DEVICE LAB FINDINGS AND OBSERVATIONS CAN BE REFERRED THROUGH THE ATTACHED FILES. (B)(4) WAS CREATED TO INVESTIGATE THE USE OF THE DAMAGED DEVICE DOCUMENT REVIEW INCLUDING IFU REVIEW 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 C1872367 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 C1872367 . THE NOTES SECTION OF THE INSTRUCTIONS FOR USE, IFU0077, 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 EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE (IFU0077). IMAGE REVIEW: N/A. ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE OF THE USER NOT READING OR FOLLOWING THE IFU WAS IDENTIFIED FROM THE INFORMATION PROVIDED. IT IS KNOWN THAT THE USER OBSERVED A KINK ON THE DEVICE UPON OPENING THE PACKAGING. THE USER PROCEEDED TO USE THE DAMAGE DEVICE SUMMARY: COMPLAINT IS CONFIRMED BASED ON THE CUSTOMERS TESTIMONY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT 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

    IT WAS REPORTED THAT THE SHEATH WAS ALREADY KINKED IN THE PACKAGE AND ISSUE WAS NOTICED WHEN THE USER UNPACKED THE DEVICE. HOWEVER, THE DEVICE WAS STILL USED ON THE PATIENT. CONFIRMED BY SALES REPRESENTATIVE ON 28-MAR-2022 THAT "THEY TOLD ME THAT THEY SAW THE KINK WHEN THEY UNPACK THE DEVICE BUT EVEN THEN THEY USE THE PRODUCT." LAB EVALUATION: 04 APRIL 2022. VISUAL INSPECTION: NO ISSUES OBSERVED WITH THE DEVICE. FUNCTIONAL INSPECTION: SHEATH EXTENDER ABLE TO ADVANCE AND RETRACT WITHOUT ISSUE. NEEDLE ABLE TO ADVANCE AND RETRACT WITHOUT ISSUE. STYLET ABLE TO BE REMOVED FROM DEVICE AND NO ISSUE OBSERVED. STYLET RE-INSERTED WITHOUT ISSUE. NEEDLE REMOVED FROM DEVICE AND NO ISSUE OBSERVED.

    Description of Event or Problem · 0

    SUPPLEMENTAL REPORT IS BEING SUBMITTED AS A CANCELLATION REPORT FOLLOWING THE COMPLETION OF THE INVESTIGATION AS THE COMPLAINT NO LONGER MEETS THE DESCRIPTION OF A REPORTABLE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    167073 ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE FCG KIT, NEEDLE, BIOPSY FCG COOK IRELAND LTD C1872367 10827002347851

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown