BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHOTIP ULTRA ENDOBRONCHIAL HD ULTRASOUND NEEDLE

    MDR report key: 6604062 · Received June 1, 2017

    Report

    Report Number
    3001845648-2017-00197
    Event Type
    Injury
    Date Received
    June 1, 2017
    Date of Event
    April 12, 2017
    Report Date
    October 6, 2017
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FCG
    UDI-DI
    00827002534087
    Report Source
    Manufacturer report
    Reporter Location
    ES
    Reporter Occupation
    PHYSICIAN

    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 1 X ECHO-HD-22-EBUS-P FROM LOT NUMBER C1333777 WAS RETURNED TO CIRL FOR EVALUATION. UPON EVALUATION OF THE RETURNED DEVICE THE FOLLOWING WAS NOTED THERE WAS A DISTAL BREAK OF THE NEEDLE IN THE DIMPLED SECTION. THE BROKEN PART OF THE NEEDLE WAS NOT RETURNED. THE CUSTOMER COMPLAINT IS CONSIDERED CONFIRMED AS NEEDLE 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# C1315041 DID NOT REVEAL ANY DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. 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

    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 ADDITIONAL INFORMATION RECEIVED -8 JUNE 2017 :"YES, AN ADDITIONAL GASTROSCOPY WAS PERFORMED TO REMOVE THE BROKEN PIECE." 1 X ECHO-HD-22-EBUS-P FROM LOT NUMBER C1333777 WAS RETURNED TO CIRL FOR EVALUATION. UPON EVALUATION OF THE RETURNED DEVICE THE FOLLOWING WAS NOTED THERE WAS A DISTAL BREAK OF THE NEEDLE IN THE DIMPLED SECTION. THE BROKEN PART OF THE NEEDLE WAS NOT RETURNED. THE CUSTOMER COMPLAINT IS CONSIDERED CONFIRMED AS NEEDLE BROKEN. A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO EXCESSIVE FORCE HOWEVER THIS CANNOT BE REPLICATED IN THE LAB. 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. (QSI0975, FQC0228 AND FQC0120) AS PER QSI0975 ALL PRODUCTS AND PACKAGING ARE 100% INSPECTED FOR VISUAL IRREGULARITIES SUCH AS HOLES, DENTS, KINKS OR TEARS. AS PER FQC0228, THERE IS A CHECK ON EACH DEVICE TO MEASURE THE NEEDLE EXTENSION AND INSPECT IT TO ENSURE IT IS FREE FROM ANY DAMAGE / KINKS. THE NEEDLE TIP AND NOTCH CUT-OUT AREA IS ALSO INSPECTED TO ENSURE IT IS FREE FROM ANY DAMAGE. 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

    TRYING TO DO A BIOPSY IN PULMONARY NODULE LOCATED IN L4 REGION THE NEEDLE BROKE, THE REGION WAS NO CARTILAGE. THEY DID THE JAB WITH THE STYLET IN THE NEEDLE IN THE CORRECT PLACE. THEY DIDN'T REMOVE THE STYLET BEFORE JAG THE LESION. THE RESULT WAS THAT THE END OF THE NEEDLE WAS BROKEN AND THIS PART WAS LOCATED AFTER WITH A GASTROSCOPE IN THE STOMACH OF THE PATIENT.

    Description of Event or Problem · 0

    THIS FOLLOW UP MDR IS BEING SUBMITTED DUE TO ADDITIONAL INFORMATION PROVIDED BY THE REP: GASTROSCOPY CONDUCTED TO RETRIEVE BROKEN NEEDLE AND ROOT CAUSE PROVIDED BY INVESTIGATIONS. TRYING TO DO A BIOPSY IN PULMONARY NODULE LOCATED IN L4 REGION THE NEEDLE BROKE, THE REGION WAS NO CARTILAGE. THEY DID THE JAB WITH THE STYLET IN THE NEEDLE IN THE CORRECT PLACE. THEY DIDN'T REMOVE THE STYLET BEFORE JAG THE LESION. THE RESULT WAS THAT THE END OF THE NEEDLE WAS BROKEN AND THIS PART WAS LOCATED AFTER WITH A GASTROSCOPE IN THE STOMACH OF THE PATIENT.

    Additional Manufacturer Narrative · 1

    PMA/510(K) # K160229. (B)(4). EXEMPTION NUMBER: E2016031. IMPORTER SITE CONTACT AND ADDRESS: (B)(4). IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: (B)(4). 1 X ECHO-HD-22-EBUS-P WAS RETURNED TO CIRL FOR EVALUATION. UPON EVALUATION OF THE RETURNED DEVICE THE FOLLOWING WAS NOTED THERE WAS A DISTAL BREAK OF THE NEEDLE IN THE DIMPLED SECTION . THE BROKEN PART OF THE NEEDLE WAS NOT RETURNED. THE CUSTOMER COMPLAINT IS CONSIDERED CONFIRMED AS NEEDLE BROKEN. A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO A TORTUROUS ANATOMY OR A TORTUROUS POSITION HOWEVER THIS CANNOT BE REPLICATED IN THE LAB. 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# C1315041 DID NOT REVEAL ANY DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. THE NOTES SECTION OF THE INSTRUCTIONS FOR USE 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 · 1

    THIS FOLLOW UP MDR IS BEING SUBMITTED DUE TO UPDATE IN THE INVESTIGATION. TRYING TO DO A BIOPSY IN PULMONARY NODULE LOCATED IN L4 REGION THE NEEDLE BROKE, THE REGION WAS NO CARTILAGE. THEY DID THE JAB WITH THE STYLET IN THE NEEDLE IN THE CORRECT PLACE. THEY DIDN'T REMOVE THE STYLET BEFORE JAG THE LESION. THE RESULT WAS THAT THE END OF THE NEEDLE WAS BROKEN AND THIS PART WAS LOCATED AFTER WITH A GASTROSCOPE IN THE STOMACH OF THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387289 ECHOTIP ULTRA ENDOBRONCHIAL HD ULTRASOUND NEEDLE FCG KIT, NEEDLE, BIOPSY FCG COOK IRELAND LTD G53408 00827002534087

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention