BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHOTIP ULTRA HIGH DEFINITION ULTRASOUND ACCESS NEEDLE

    MDR report key: 8231786 · Received January 9, 2019

    Report

    Report Number
    3001845648-2019-00006
    Event Type
    Malfunction
    Date Received
    January 9, 2019
    Date of Event
    December 7, 2018
    Report Date
    January 9, 2019
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FCG
    UDI-DI
    00827002520127
    PMA / PMN Number
    K092359
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    510 (K) NUMBER; K092359. 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; K092359. COOK IRELAND LTD (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI)(IMPORTER). EXEMPTION NUMBER: E2016031. INFORMATION PERTAINING (B)(4). IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: (B)(4). THE DEVICE RELATED TO THIS OCCURRENCE UNDERWENT A LABORATORY EVALUATION ON 09 JAN 2019. THE NEEDLE WAS FOUND TO BE KINKED DISTALLY. A PROXIMAL KINK WAS ALSO OBSERVED DURING THE LAB EVALUATION. A NEW PR WAS REQUESTED TO BE OPENED FOR THIS EXTRA FAILURE MODE DOCUMENT REVIEW PRIOR TO DISTRIBUTION, ALL ECHO-HD-19-A 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-19-A OF LOT NUMBER C1487122 DID NOT REVEAL ANY DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. THE REVIEW OF RELEVANT MANUFACTURING RECORDS, CONFIRMS THE FAILURE MODE HAS NOT PREVIOUSLY OCCURRED WITH THE CURRENT LOT NUMBER. BASED ON THE INFORMATION AVAILABLE TO DATE, THERE IS NO EVIDENCE TO SUGGEST THAT THERE ARE ANY MANUFACTURING ISSUES ASSOCIATED WITH LOT NUMBER C1487122. IFU REVIEW THE NOTES SECTION OF THE INSTRUCTIONS FOR USE, IFU0050-2, WHICH 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". THERE IS NO EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE (IFU0050-2). ROOT CAUSE REVIEW THE FAILURE OF NEEDLE KINKED/BENT WAS CONCLUDED FROM THE AVAILABLE INFORMATION. A DEFINITIVE ROOT CAUSE FOR THE CUSTOMER COMPLAINT COULD NOT BE DETERMINED AS CIRCUMSTANCES OF USE CANNOT BE REPLICATED IN THE LABORATORY. A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO HANDLING ERROR DURING REMOVAL OF NEEDLE OVER WIRE GUIDE. SUMMARY COMPLAINT IS CONFIRMED AS THE FAILURE WAS VERIFIED IN THE LABORATORY. ACCORDING TO THE INITIAL REPORTER, 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

    THE DOCTOR TRIED THE EUS - PSEUDOCYST DRAINAGE. SO HE PUNCTURED TO THE TARGET BY USING ECHO-HD-19-A. AND INSERTED GUIDE WIRE THROUGH THE NEEDLE. AND REMOVED THE ECHO-HD-19-A. BUT GUIDE WIRE WAS MISSED, CAME OUT. SO HE HAD TO USE ECHO-HD-19-A,. BUT, THE NURSE REALIZED THE SHEATH TIP WAS BENT, AND TOUCHED IT. THEN, TIP WAS BROKEN. SO, THEY USED A NEW ONE.

    Description of Event or Problem · 0

    DEVICE WAS EVALUATED THE 09-JAN-2019: NO NEEDLE BREAK PRESENT, THE NEEDLE WAS KINKED DISTALLY THE DOCTOR TRIED THE EUS - PSEUDOCYST DRAINAGE. SO HE PUNCTURED TO THE TARGET BY USING ECHO-HD-19-A. AND INSERTED GUIDE WIRE THROUGH THE NEEDLE. AND REMOVED THE ECHO-HD-19-A. BUT GUIDE WIRE WAS MISSED, CAME OUT. SO HE HAD TO USE ECHO-HD-19-A,. BUT, THE NURSE REALIZED THE SHEATH TIP WAS BENT, AND TOUCHED IT. THEN, TIP WAS BROKEN. SO, THEY USED A NEW ONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24817 ECHOTIP ULTRA HIGH DEFINITION ULTRASOUND ACCESS NEEDLE FCG KIT, NEEDLE, BIOPSY FCG COOK IRELAND LTD G52012 C1487122 00827002520127

    Patients

    Seq Age Sex Outcome Treatment
    1