BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHOTIP PROCORE ENDOBRONCHIAL HD BIOPSY NEEDLE

    MDR report key: 6810656 · Received August 22, 2017

    Report

    Report Number
    3001845648-2017-00350
    Event Type
    Injury
    Date Received
    August 22, 2017
    Date of Event
    July 25, 2017
    Report Date
    August 21, 2017
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FCG
    UDI-DI
    00827002342798
    Report Source
    Manufacturer report
    Reporter Location
    GB
    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 IT WAS ORIGINALLY INDICATED THAT THE DEVICE INVOLVED IN THIS COMPLAINT WAS BEING RETURNED TO COOK IRELAND FOR EVALUATION; THE DEVICE HAS NOT YET BEEN RECEIVED, HOWEVER, IF IT IS RETURNED, THE DEVICE WILL BE EVALUATED AND THE INVESTIGATION WILL BE UPDATED. AS THE DEVICE WAS NOT RETURNED FOR EVALUATION; THE CAUSE OF THIS COMPLAINT COULD NOT BE CONCLUSIVELY DETERMINED. HOWEVER, A POSSIBLE CAUSE MAY BE THAT THE NEEDLE COULD HAVE HIT A TRACHEAL RING POTENTIALLY CAUSING THE NEEDLE TO BREAK. WITH THE INFORMATION PROVIDED A DOCUMENT BASED INVESTIGATION WAS CARRIED OUT. THE CUSTOMER COMPLAINT IS CONSIDERED TO BE CONFIRMED BASED ON CUSTOMER TESTIMONY. PRIOR TO DISTRIBUTION, ALL ECHO-HD-22-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. A REVIEW OF THE MANUFACTURING RECORDS FOR ECHO-HD-22-EBUS-P-C DEVICES OF LOT# C1345553 DID NOT REVEAL ANY DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. THE NOTES SECTION OF THE INSTRUCTIONS FOR USE, IFU0110-5, INSTRUCTS THE USER TO VISUALLY 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". FROM THE INFORMATION PROVIDED, THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT AS A RESULT OF THIS OCCURRENCE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    CUSTOMER ADVISED THEY HAVE AN EBUS NEEDLE THAT BROKE OFF THE MIDDLE OF THE PROCEDURE AND EMBEDDED IN THE PATIENT TRACHEA ABOUT 1.5 CM IN LENGTH BUT WAS RETRIEVED USING BRONCHOSCOPY BIOPSY FORCEPS.

    Additional Manufacturer Narrative · 1

    (B)(4). EXEMPTION NUMBER: E2016031. (B)(4). PMA/510(K) #: K160229. 1 X ECHO-HD-22-EBUS-P-C FROM LOT NUMBER C1345553 WAS RETURNED TO COOK (B)(4) FOR EVALUATION. UPON EVALUATION OF THE RETURNED DEVICE THE FOLLOWING WAS NOTED: THE STYLET WAS IN PLACE BUT NOT FULLY INSERTED. THE BROKEN PART OF THE NEEDLE WAS RETURNED IN A CONTAINER. THE NEEDLE BROKE AT THE DISTAL END, 18MM FROM THE DISTAL TIP. THE HANDLE ADVANCES AND RETRACTS FINE THE STYLET WAS PROTRUDING FROM THE NEEDLE LUER APPROXIMATELY 18MM WHICH MATCHES THE LENGTH OF THE BROKEN NEEDLE. THE CUSTOMER COMPLAINT IS CONFIRMED AS THE NEEDLE WAS BROKEN DISTALLY. A POSSIBLE ROOT CAUSE FOR THIS OCCURRENCE COULD BE DUE TO A TORTUROUS ANATOMY OR POSSIBLY BROKE WHEN THE NEEDLE WAS ADVANCED INTO THE TRACHEAL RINGS. PRIOR TO DISTRIBUTION, ALL ECHO-HD-22-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 COOK (B)(4). A REVIEW OF THE MANUFACTURING RECORDS FOR ECHO-HD-22-EBUS-P-C DEVICES OF LOT# C1345553 DID NOT REVEAL ANY DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. FROM THE INFORMATION PROVIDED, THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT AS A RESULT OF THIS OCCURRENCE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 1

    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: CUSTOMER ADVISED THEY HAVE AN EBUS NEEDLE THAT BROKE OFF THE MIDDLE OF THE PROCEDURE AND EMBEDDED IN THE PATIENT TRACHEA ABOUT 1.5CM IN LENGTH BUT WAS RETRIEVED USING BRONCHOSCOPY BIOPSY FORCEPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590587 ECHOTIP PROCORE ENDOBRONCHIAL HD BIOPSY NEEDLE FCG KIT, NEEDLE, BIOPSY FCG COOK IRELAND LTD G34279 00827002342798

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention