BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHOTIP PROCORE ENDOBRONCHIAL HD BIOPSY NEEDLE

    MDR report key: 7133671 · Received December 20, 2017

    Report

    Report Number
    3001845648-2017-00597
    Event Type
    Malfunction
    Date Received
    December 20, 2017
    Date of Event
    November 27, 2017
    Report Date
    January 17, 2018
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FCG
    UDI-DI
    00827002342804
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) # 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 PENDING. A FOLLOW UP MDR WILL BE SUBMITTED WITH THE INVESTIGATION CONCLUSIONS.

    Additional Manufacturer Narrative · 0

    PMA/510(K) # 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. LAB EVALUATION: 1 X ECHO-HD-25-EBUS-P-C FROM LOT NUMBER C1328131 WAS RETURNED TO CIRL FOR EVALUATION. UPON EVALUATION THE FOLLOWING WAS NOTED THE DEVICE WAS RETURNED IN ITS ORIGINAL PACKAGING, THE STYLET WAS PARTIALLY OUT ON RETURN. THERE WAS NO NEEDLE EXPOSURE. THERE WAS NO CRACKING A THE THUMBSCREWS OR THE MLLA. THERE IS A DISTAL BEND APPROXIMATELY 95CM FROM THE TIP AND THERE IS A PROXIMAL BEND APPROXIMATELY 25.8CM FROM THE SHEATH EXTENDER. THE NEEDLE CAN ADVANCE RETRACT WITHOUT ANY ISSUES. AN ADDITIONAL PR HAS BEEN OPENED TO ADDRESS THE PROXIMAL BEND. THE CUSTOMER COMPLAINT IS CONSIDERED TO BE CONFIRMED AS THERE WAS A BEND IN THE NEEDLE DISTALLY. THE COMPLAINT WAS VERIFIED IN LAB. ROOT CAUSE: A POSSIBLE ROOT CAUSE FOR THE OCCURRENCE MAY BE DUE TO THE DEVICE HITTING OFF THE TRACHEAL RINGS CAUSING THE NEEDLE TO BEND. DOCUMENTS REVIEW: A REVIEW OF THE MANUFACTURING RECORDS FOR ECHO-HD-25-EBUS-P-C DEVICE OF LOT# C1328131 DID NOT REVEAL ANY DISCREPANCIES THAT MAY HAVE LEAD TO THIS OCCURRENCE. THERE IS NO EVIDENCE TO SUGGEST THAT THIS ISSUE EFFECTS THE ENTIRE LOT # C1328131; UPON REVIEW OF COMPLAINTS THIS FAILURE MODE HAS NOT OCCURRED PREVIOUSLY WITH THIS LOT # C1328131. PRIOR TO DISTRIBUTION, ALL ECHO-HD-25-EBUS-P-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. IFU REVIEW: THE NOTES SECTION OF THE INSTRUCTIONS FOR USE, IFU0110-5 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, IT STATES IN THE IFU THAT AN OLYMPUS EBUS SCOPE IS INTENDED TO BE USED WITH THE DEVICE". FROM THE INFORMATION PROVIDED: THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE COMPLAINTS OF THIS NATURE WILL CONTINUE TO ME MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    NEEDLE REACHED ENDOBRONCHIAL(4R) AND COMPLETED FIRST PUNCTURE THEN WITHDRAW THE DEVICE OUT OF PATIENT WHEN THE TIP BENT WAS DETECTED. REPLACE A NEW SAME DEVICE TO CONTINUE THE PROCEDURE WITH TIP BENT AGAIN. WITH ANOTHER NEW SAME DEVICE TO COMPLETE THE PROCEDURE.

    Description of Event or Problem · 0

    THIS FOLLOW UP REPORT IS BEING SUBMITTED DUE TO THE CONCLUSION INTO THE INVESTIGATION OF THIS EVENT. NEEDLE REACHED ENDOBRONCHIAL(4R) AND COMPLETED FIRST PUNCTURE THEN WITHDREW THE DEVICE OUT OF PATIENT WHEN THE NEEDLE TIP BEND WAS DETECTED. REPLACED WITH A NEW SAME DEVICE TO CONTINUE THE PROCEDURE WITH TIP BENT AGAIN. THEN WITH ANOTHER NEW SAME DEVICE TO COMPLETE THE PROCEDURE.

    Additional Manufacturer Narrative · 1

    PMA/510(K) # K160229. COOK (B)(4) (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI)(IMPORTER). EXEMPTION NUMBER: E2016031. INFORMATION PERTAINING TO MFR SITE AS FOLLOWS: IMPORTER SITE CONTACT AND ADDRESS: (B)(4). IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: (B)(4). INVESTIGATION IS PENDING. A FOLLOW UP MDR WILL BE SUBMITTED WITH THE INVESTIGATION CONCLUSIONS. COOK (B)(4) (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI)(IMPORTER). EXEMPTION NUMBER: E2016031. INFORMATION PERTAINING TO MFR SITE AS FOLLOWS: IMPORTER SITE CONTACT AND ADDRESS: (B)(4). IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: (B)(4). INVESTIGATION IS PENDING. A FOLLOW UP MDR WILL BE SUBMITTED WITH THE INVESTIGATION CONCLUSIONS.

    Description of Event or Problem · 1

    NEEDLE REACHED ENDOBRONCHIAL(4R) AND COMPLETED FIRST PUNCTURE THEN WITHDRAW THE DEVICE OUT OF PATIENT WHEN THE TIP BENT WAS DETECTED. REPLACE A NEW SAME DEVICE TO CONTINUE THE PROCEDURE WITH TIP BENT AGAIN. WITH ANOTHER NEW SAME DEVICE TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    914588 ECHOTIP PROCORE ENDOBRONCHIAL HD BIOPSY NEEDLE FCG KIT, NEEDLE, BIOPSY FCG COOK IRELAND LTD G34280 00827002342804

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR