BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHOTIP ULTRA ENDOBRONCHIAL HD ULTRASOUND NEEDLE

    MDR report key: 6536360 · Received May 2, 2017

    Report

    Report Number
    3001845648-2017-00156
    Event Type
    Injury
    Date Received
    May 2, 2017
    Date of Event
    March 29, 2017
    Report Date
    May 2, 2017
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FCG
    UDI-DI
    00827002534087
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    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. PMA/510(K) # K160229. 1 X ECHO-HD-22-EBUS-P LOT NUMBER C1320162 WAS RETURNED TO CIRL FOR EVALUATION. UPON EVALUATION OF THE DEVICE THE FOLLOWING WAS NOTED: THE NEEDLE WAS FULLY RETRACTED, THE STYLET WAS PARTIALLY OUT. THE NEEDLE WAS KINKED AT MARK ONE IN RETURN, PACKAGED AT MARK THREE BUT RETURNED AT MARK ONE. THERE WAS APPROXIMATELY 2-2.5CM OF THE NEEDLE TIP MISSING, NOT RETURNED. THE CUSTOMER COMPLAINT IS CONSIDERED TO BE CONFIRMED DUE TO NEEDLE BEING BROKEN. R&D ROOT CAUSE RESPONSE :THE MOST PLAUSIBLE CAUSE IS EXCESSIVE FORCE APPLIED DURING PUNCTURE. APPROACHING FROM AN DIFFICULT POSITION LIKELY CONTRIBUTED TO THIS TYPE OF FAILURE ALSO. PRIOR TO DISTRIBUTION, ALL ECHO-HD-22-EBUS-P DEVICES ARE SUBJECTED TO FUNCTIONAL CHECKS AND VISUAL INSPECTION TO ENSURE INTEGRITY OF THE PRODUCT. THESE INSPECTIONS AND FUNCTIONAL CHECKS ARE OUTLINED IN INTERNAL PROCEDURES IN PLACE AT CIRL. A REVIEW OF THE MANUFACTURING RECORDS FOR ECHO DEVICES OF LOT# C1320162 DID NOT REVEAL ANY DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. THE NOTES SECTION OF THE INSTRUCTIONS FOR USE IFU0060-2 THAT ACCOMPANIES THIS DEVICE INSTRUCTS THE USER TO INSPECT THE DEVICE PRIOR TO USE FOR ANY DAMAGE: "VISUALLY INSPECT WITH PARTICULAR ATTENTION TO KINKS, BENDS AND BREAKS. IF AN ABNORMALITY IS DETECTED THAT WOULD PROHIBIT PROPER WORKING CONDITION, DO NOT USE". FROM THE INFORMATION PROVIDED TO US 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.

    Additional Manufacturer Narrative · 0

    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. PMA/510(K) # K160229. 1 X ECHO-HD-22-EBUS-P LOT NUMBER C1320162 WAS RETURNED TO CIRL FOR EVALUATION. UPON EVALUATION OF THE DEVICE THE FOLLOWING WAS NOTED: THE NEEDLE WAS FULLY RETRACTED, THE STYLET WAS PARTIALLY OUT. THE NEEDLE WAS KINKED AT MARK ONE IN RETURN, PACKAGED AT MARK THREE BUT RETURNED AT MARK ONE. THERE WAS APPROXIMATELY 2-2.5CM OF THE NEEDLE TIP MISSING, NOT RETURNED. THE CUSTOMER COMPLAINT IS CONSIDERED TO BE CONFIRMED DUE TO NEEDLE BEING BROKEN. PRIOR TO DISTRIBUTION, ALL ECHO-HD-22-EBUS-P DEVICES ARE SUBJECTED TO FUNCTIONAL CHECKS AND VISUAL INSPECTION TO ENSURE INTEGRITY OF THE PRODUCT. THESE INSPECTIONS AND FUNCTIONAL CHECKS ARE OUTLINED IN INTERNAL PROCEDURES IN PLACE AT CIRL. A REVIEW OF THE MANUFACTURING RECORDS FOR ECHO DEVICES OF LOT# C1320162 DID NOT REVEAL ANY DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. THE NOTES SECTION OF THE INSTRUCTIONS FOR USE IFU0060-2 THAT ACCOMPANIES THIS DEVICE INSTRUCTS THE USER TO INSPECT THE DEVICE PRIOR TO USE FOR ANY DAMAGE: "VISUALLY INSPECT WITH PARTICULAR ATTENTION TO KINKS, BENDS AND BREAKS. IF AN ABNORMALITY IS DETECTED THAT WOULD PROHIBIT PROPER WORKING CONDITION, DO NOT USE". FROM THE INFORMATION PROVIDED TO US 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

    A FOLLOW-UP MDR IS BEING SUBMITTED DUE TO THE RECEIPT OF ADDITIONAL INFORMATION. INITIAL REPORT DETAILS: DURING PUNCTION THE DISTAL TIP BROKE OFF IN THE PATIENT..

    Description of Event or Problem · 0

    DURING PUNCTION THE DISTAL TIP BROKE OFF IN THE PATIENT..

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319446 ECHOTIP ULTRA ENDOBRONCHIAL HD ULTRASOUND NEEDLE FCG KIT, NEEDLE, BIOPSY FCG COOK IRELAND LTD 00827002534087

    Patients

    Seq Age Sex Outcome Treatment
    1