BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE

    MDR report key: 7850158 · Received September 6, 2018

    Report

    Report Number
    3001845648-2018-00411
    Event Type
    Malfunction
    Date Received
    September 6, 2018
    Date of Event
    July 26, 2018
    Report Date
    September 6, 2018
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FCG
    UDI-DI
    00827002315204
    PMA / PMN Number
    K083330
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    510(K) NUMBER; K083330. 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: K083330. 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)(6). IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: 3005580113. DEVICE EVALUATION: THE ECHO-19 DEVICE OF LOT NUMBER C1463132 DEVICE INVOLVED IN THIS COMPLAINT WAS RETURNED FOR EVALUATION, WITHOUT ORIGINAL PACKAGING. WITH THE INFORMATION PROVIDED, A PHYSICAL EXAMINATION AND DOCUMENT BASED INVESTIGATION WAS CONDUCTED. ADDITIONAL INFORMATION WAS RECEIVED AS FOLLOWS: 1.IF THE REPORT INVOLVES A KINK OR BEND IN THE NEEDLE, WHERE IS THIS LOCATED ON THE DEVICE (HANDLE END (PROXIMAL END) OR PATIENT END (DISTAL END))? DISTAL END 2.PLEASE DESCRIBE THE LOCATION IN THE BODY FOR THE INTENDED TARGET SITE (PANCREAS, STOMACH, LUNGS ETC.). STOMACH A.IF THE LUNGS, WHICH LYMPH NODE WAS BEING TARGETED? E.G. 2R, 2L, 4R, AO, AR, 11RI, 11S ETC. 3.PLEASE DESCRIBE THE SIZE OF THE INTENDED TARGET SITE. AROUND 2CM 4.IF NOT WITH THE DEVICE IN QUESTION, HOW WAS THE PROCEDURE PERFORMED AND/OR FINISHED? NO. 5.WAS THE DEVICE USED IN A TORTUOUS POSITION? NO. 6.ARE IMAGES OF THE DEVICE OR PROCEDURE AVAILABLE? NO. 7.WAS IT DAMAGED IN PACKAGING BEFORE REMOVAL? NO. 8.WAS IT DAMAGED ON REMOVAL FROM PACKAGING? NO. 9.WAS FORCE REQUIRED TO REMOVE THE DEVICE? A LITTLE 10.WHAT IS THE ENDOSCOPE MANUFACTURER AND MODEL NUMBER THAT WAS USED? OLYMPUS GF-UCT240-AL5 11.WAS THE SCOPE RECENTLY SERVICED / REPAIRED? NO. 12.WAS FORCE REQUIRED ON INSERTION OF DEVICE INTO SCOPE? NO. 13.WHEN WAS THE ISSUED NOTED? E.G. ON ADVANCEMENT OF THE SHEATH/NEEDLE OR ON NEEDLE RETRACTION? ON NEEDLE 15.WAS DIFFICULTY EXPERIENCED WHILE RETRACTING THE NEEDLE? YES 16.WAS THE NEEDLE ABLE TO BE FULLY RETRACTED BEFORE REMOVING FROM THE PATIENT? NO. 17.WAS GAINING ACCESS TO THE TARGETED SITE DIFFICULT? NO. 18.WAS THE ENDOSCOPE IN A FLEXED OR TWISTED POSITION AT ANY TIME DURING THE PROCEDURE? FLEXED. 19.WAS NEEDLE PENETRATION OF THE TARGETED SITE DIFFICULT? NO. 20.WAS THE STYLET FULLY IN PLACE INSIDE THE NEEDLE WHEN ADVANCING INTO THE TARGETED SITE? YES. 21.WAS THE STYLET PARTIALLY REMOVED PRIOR TO ADVANCEMENT OF NEEDLE? YES. 22.HOW MANY BIOPSIES/PASSES WERE OBTAINED WITH USE OF THIS NEEDLE? 1. 23.DID ANY SECTION OF THE DEVICE DETACH INSIDE THE PATIENT? NO. 24.IF KINKED BELOW THE SHEATH EXTENDER, DID THEY NOTICE THE KINK BEFORE PLACING THE DEVICE INTO THE SCOPE? NO. 25.WAS THERE DIFFICULTY OR SLIPPING EXPERIENCED OF THE SHEATH EXTENDER OR LOCK RING DURING USE? NO. 26.WAS THERE DIFFICULTY IN ATTACHMENT / DETACHMENT OF THE LEUR TO THE SCOPE? NO. 27.IF THE DEVICE IS PROCORE AND IT IS KINKED DISTALLY, IS THE KINK AT THE NOTCH / CORE TRAP? THE COMPLAINT DEVICE UNDERWENT A LABORATORY EVALUATION ON THE (B)(6) 2018. ON EVALUATION OF THE RETURNED DEVICE IT WAS NOTED THAT THERE WAS A PROXIMAL NEEDLE BREAKAGE. VISUAL AND FUNCTIONAL CHECK WERE CARRIED OUT. DEVICE DISMANTLED, PROXIMAL END OF BROKEN NEEDLE MEASURED 31.1 CM (FROM BOTTOM OF HUB). REST OF NEEDLE MEASURED AT 139.1 CM (SPECIFICATION FOR SHEATH HOLDER 1705MM +2MM/-2MM). FOLLOWING THE LABORATORY EVALUATION ADDITIONAL INFORMATION WAS REQUESTED. AS PER ADDITIONAL INFORMATION RECEIVED, COMPLAINT DEVICE INVOLVES A DISTAL KINK IN THE NEEDLE. HOWEVER AS PER IMAGES RECEIVED FROM CUSTOMER AND AS PER LABORATORY EVALUATION THERE IS NO EVIDENCE OF A DISTAL KINK IN THE NEEDLE. THEREFORE, THERE IS NO EVIDENCE TO SUPPORT DISTAL KINK FAILURE. COMPLAINT IS CONFIRMED AS THE FAILURE WAS VERIFIED IN THE LABORATORY. ROOT CAUSE: A DEFINITIVE ROOT CAUSE FOR THE CUSTOMER COMPLAINT COULD NOT BE DETERMINED HOWEVER POSSIBLE CAUSES MAY BE THAT THE NEEDLE BREAKAGE OCCURRED WHILE THE ENDOSCOPE OF THE DEVICE WAS IN THE TWISTED POSITION. ADDITIONALLY ANOTHER POSSIBLE CAUSE OF THIS COMPLAINT IS THAT THE DEVICE WAS USED WITH EXCESSIVE FORCE POSSIBLY WHEN ATTACHING OR DETACHING OF THE DEVICE, THIS IS TURN LED TO A BROKEN NEEDLE. A CAPA HAS BEEN INITIATED TO DOCUMENT AND TRACK THE ACTIONS TAKEN TO INVESTIGATE AND TO ADDRESS KINKING OR BREAKING OF THE SHEATH AT THE SHEATH/SHEATH EXTENDER JUNCTION DOCUMENT REVIEW: COMPONENTS FROM EXTERNAL SUPPLIERS ARE SUBJECT TO INCOMING INSPECTION. A REVIEW OF MANUFACTURING RECORDS WERE PERFORMED FOR LOT C1463132 AND THERE WERE NO DISCREPANCIES WHICH COULD HAVE CONTRIBUTED TO THIS OCCURRENCE. THERE IS NO EVIDENCE TO SUGGEST THAT THIS ISSUE EFFECTS THE ENTIRE LOT # C1463132; UPON REVIEW OF COMPLAINTS THIS FAILURE MODE HAS NOT OCCURRED PREVIOUSLY WITH THIS LOT # C1463132. PRIOR TO DISTRIBUTION, ALL ECHO-19 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 INSTRUCTIONS FOR USE, IFU0101-0, ADVISES THE USER TO ¿ADVANCE NEEDLE INTO LESION. REMOVE STYLET FROM NEEDLE BY GENTLY PULLING BACK ON PLASTIC HUB SEATED IN METAL FITTING OF HANDLE." THERE IS EVIDENCE TO SUGGEST THAT THE USER DID NOT FOLLOW THE INSTRUCTIONS FOR USE (IFU0101-0). AS PER ADDITIONAL INFORMATION RECEIVED THE STYLET WAS PARTIALLY REMOVED PRIOR TO ADVANCEMENT OF NEEDLE. HOWEVER IT MAY BE NOTED THAT THIS WOULD NOT CAUSE THE PROXIMAL NEEDLE BREAKAGE. SUMMARY COMPLAINT IS CONFIRMED AS THE FAILURE WAS VERIFIED IN THE LABORATORY. THE RISK WAS DETERMINED TO BE NO RISK (CATEGORY III). FROM THE INFORMATION PROVIDED, NO ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED 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

    NEEDLE DETACHED FROM HANDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    693048 ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE FCG KIT, NEEDLE, BIOPSY FCG COOK IRELAND LTD G31520 C1463132 00827002315204

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR