BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHOTIP PROCORE ENDOBRONCHIAL HD BIOPSY NEEDLE

    MDR report key: 8184440 · Received December 20, 2018

    Report

    Report Number
    3001845648-2018-00613
    Event Type
    Injury
    Date Received
    December 20, 2018
    Date of Event
    November 30, 2018
    Report Date
    January 17, 2019
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FCG
    UDI-DI
    00827002342828
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    510(K) NUMBER: K160229. COOK IRELAND LTD (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI)(IMPORTER). EXEMPTION NUMBER: E2016031. INFORMATION PERTAINING TO SECTION G. 1 AS FOLLOWS: IMPORTER SITE CONTACT AND ADDRESS: (B)(4) COOK MEDICAL INCORPORATED (CMI) 1025 ACUFF ROAD P.O BOX 4195 BLOOMINGTON INDIANA 47402-4195. IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: 3005580113. INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Additional Manufacturer Narrative · 0

    510 (K) NUMBER; K160229. COOK IRELAND LTD (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI)(IMPORTER). EXEMPTION NUMBER: E2016031. INFORMATION PERTAINING TO SECTION G. 1 AS FOLLOWS: IMPORTER SITE CONTACT AND ADDRESS: (B)(4). COOK MEDICAL INCORPORATED (CMI) 1025 ACUFF ROAD P.O BOX 4195 BLOOMINGTON INDIANA 47402-4195. IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: 3005580113. THIS FOLLOW UP REPORT IS BEING SUBMITTED DUE TO THE EVALUATION OF THE DEVICE INVOLVED IN THIS EVENT AND THE CONCLUSION OF THIS INVESTIGATION. 1 X ECHO-HD-25-EBUS-O-C WAS RETURNED TO CIRL FOR EVALUATION. THE NEEDLE WAS OBSERVED TO BE BROKEN AT THE DISTAL END. COMPLAINT IS CONFIRMED AS THE FAILURE WAS VERIFIED DURING LAB EVALUATION. FROM THE INFORMATION PROVIDED ¿SCOPE WAS FLEXED INITIALLY SO IT HAD CONTACT WITH THE TRACHEAL WALL. IT IS BELIEVED THE NEEDLE TIP MUST HAVE BROKEN OFF AS SCOPE WAS BEING ADVANCED.¿ PRIOR TO DISTRIBUTION, ALL ECHO-HD-25-EBUS-O-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-25-EBUS-O-C DEVICE OF LOT NUMBER C1327235 DID NOT REVEAL ANY DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THE ISSUE. THE INSTRUCTIONS FOR USE, WHICH ACCOMPANIES THIS DEVICE, INSTRUCTS THE USER TO; "VISUALLY INSPECT WITH PARTICULAR ATTENTION TO KINKS, BENDS AND BREAKS. IF AN ABNORMALITY IS DETECTED THAT WOULD PROHIBIT PROPER WORKING CONDITION, DO NOT USE". AS PER INFORMATION PROVIDED, ¿PATIENT COUGHED NEEDLE TIP UP AND IT WAS THEN RETRIEVED FROM THE TRACHEA.¿ ¿A BRONCHOSCOPE WAS PERFORMED AND THE TIP WAS RETRIEVED.¿ ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED AS THE CIRCUMSTANCES OF USE CANNOT BE REPLICATED IN THE LABORATORY. FROM THE INFORMATION PROVIDED ¿SCOPE WAS FLEXED INITIALLY SO IT HAD CONTACT WITH THE TRACHEAL WALL. IT IS BELIEVED THE NEEDLE TIP MUST HAVE BROKEN OFF AS SCOPE WAS BEING ADVANCED.¿ COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    510 (K) NUMBER; K160229. COOK IRELAND LTD (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI)(IMPORTER). EXEMPTION NUMBER: E2016031. INFORMATION PERTAINING TO SECTION G. 1 AS FOLLOWS: IMPORTER SITE CONTACT AND ADDRESS: (B)(6). COOK MEDICAL INCORPORATED (CMI) (B)(4). IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: (B)(4). INVESTIGATION IS STILL PENDING. A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Description of Event or Problem · 0

    DR (B)(6) PERFORMED AN EBUS. AT THE END OF THE PROCEDURE IT WAS NOTED THAT THE TIP OF THE NEEDLE HAD SHEARED OFF. THE PROCEDURE WAS NOT A DIFFICULT ONE. A CT WAS PERFORMED AND THE TIP WAS IN THE NODE. A BRONCHOSCOPE WAS PERFORMED AND THE TIP WAS RETRIEVED.

    Description of Event or Problem · 0

    THIS FOLLOW UP REPORT IS BEING SUBMITTED DUE TO THE EVALUATION OF THE DEVICE INVOLVED IN THIS EVENT AND THE CONCLUSION OF THIS INVESTIGATION. INITIAL REPORT DETAILS: DR. (B)(6)PERFORMED AN EBUS. AT THE END OF THE PROCEDURE IT WAS NOTED THAT THE TIP OF THE NEEDLE HAD SHEARED OFF. THE PROCEDURE WAS NOT A DIFFICULT ONE. A CT WAS PERFORMED AND THE TIP WAS IN THE NODE. A BRONCHOSCOPE WAS PERFORMED AND THE TIP WAS RETRIEVED.

    Description of Event or Problem · 0

    DR. (B)(6) PERFORMED AN EBUS. AT THE END OF THE PROCEDURE IT WAS NOTED THAT THE TIP OF THE NEEDLE HAD SHEARED OFF. THE PROCEDURE WAS NOT A DIFFICULT ONE. A CT WAS PERFORMED AND THE TIP WAS IN THE NODE. A BRONCHOSCOPE WAS PERFORMED AND THE TIP WAS RETRIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1023579 ECHOTIP PROCORE ENDOBRONCHIAL HD BIOPSY NEEDLE FCG KIT, NEEDLE, BIOPSY FCG COOK IRELAND LTD G34282 C1327235 00827002342828

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention