BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE

    MDR report key: 7282233 · Received February 20, 2018

    Report

    Report Number
    3001845648-2018-00071
    Event Type
    Malfunction
    Date Received
    February 20, 2018
    Date of Event
    January 11, 2018
    Report Date
    February 20, 2018
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FCG
    UDI-DI
    00827002315204
    PMA / PMN Number
    K083330
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    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. INVESTIGATION IS STILL PENDING. A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    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 (B)(4). IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: (B)(4). LAB EVALUATION : 1 X ECHO-19 FROM LOT# C1405819 WAS RETURNED TO CIRL FOR EVALUATION. UPON EVALUATION OF THE RETURNED DEVICE THE FOLLOWING WAS NOTED: THE DEVICE RETURNED IN ITS ORIGINAL PACKAGING. THERE IS A KINK VISIBLE BELOW THE SHEATH EXTENDER. THE STYLET WAS RETURNED OUTSIDE OF THE DEVICE. THE STYLET HAD BEEN INSERTED IN THE WRONG SIDE OF THE DEVICE. THE STYLET WAS TAKEN OUT AND INSERTED INTO THE DEVICE BUT WOULD NOT PASS THE BEND BELOW THE SHEATH EXTENDER. THE NEEDLE WAS BROKEN BELOW THE SHEATH EXTENDER AND WAS ALSO BROKEN DISTALLY. THE LENGTH OF THE BROKEN PIECES OF NEEDLE WERE MEASURED AND ACCOUNTED FOR. THE DISTAL AND PROXIMALLY BREAK ARE LINKED ADDITIONAL INFORMATION RECEIVED THE 27 FEB 2018: "THE NEEDLE WAS NOT BROKEN DURING THE PROCEDURE OR DURING EXTRACTION. MOST PROBABLY, IT WAS BROKEN DURING DECONTAMINATION OR PACKAGING." THE CUSTOMER COMPLAINT IS CONSIDERED TO BE CONFIRMED AS THE NEEDLE WAS BROKEN AT THE PROXIMAL END BELOW THE SHEATH EXTENDER, THE DISTAL BREAK WAS NOT DURING THE PROCEDURE BUT MAY HAVE BEEN DURING THE RE PACKAGING OF THE DEVICE BACK TO CIRL. A 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 BREAK BETWEEN THE SHEATH AND THE DEVICE. THE CUSTOMER ALSO STATED THAT THEY COULD NOT RETRACT THE NEEDLE THIS COULD HAVE POSSIBLY BEEN AN EFFECT OF THE NEEDLE BREAKAGE A REVIEW OF MANUFACTURING RECORDS WERE PERFORMED FOR LOT C1405819 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 # C1405819; UPON REVIEW OF COMPLAINTS THIS FAILURE MODE HAS NOT OCCURRED PREVIOUSLY WITH THIS LOT # C1405819. 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. THE INSTRUCTIONS FOR USE, IFU0101-0, ADVISES THE USER TO ¿VISUALLY INSPECT WITH PARTICULAR ATTENTION TO KINKS, BENDS OR BREAKS. IF AN ABNORMALITY IS DETECTED THAT WOULD PROHIBIT PROPER WORKING CONDITION, DO NOT USE¿. ON REVIEW OF THE INFORMATION PROVIDED, THERE IS NO VIABLE EVIDENCE TO SUGGEST THAT THE USER DID NOT FOLLOW THE INSTRUCTIONS FOR 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

    DURING THE BIOPSY OF THE LIVER, WITH THE SECOND INTRODUCTION OF THE NEEDLE, THE HANDLE WAS BLOCKED AND THE BLADES FAILED TO HIDE INTO THE INTRODUCER. THE PROCEDURE WAS ABANDONED AND THE NEEDLE WAS REMOVED WITH THE ENTIRE ENDOSCOPE. DEVICE WAS EVALUATED ON THE 14-FEB-2018 CONFIRMING: KINK VISIBLE BELOW THE SHEATH EXTENDER, PROXIMAL AND DISTAL NEEDLE BREAKAGE.

    Description of Event or Problem · 0

    DURING THE BIOPSY OF THE LIVER, WITH THE SECOND INTRODUCTION OF THE NEEDLE, THE HANDLE WAS BLOCKED AND THE BLADES FAILED TO HIDE INTO THE INTRODUCER. THE PROCEDURE WAS ABANDONED AND THE NEEDLE WAS REMOVED WITH THE ENTIRE ENDOSCOPE. DEVICE WAS EVALUATED ON THE 14-FEB-18 CONFIRMING: KINK VISIBLE BELOW THE SHEATH EXTENDER, PROXIMAL AND DISTAL NEEDLE BREAKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125161 ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE FCG KIT, NEEDLE, BIOPSY FCG COOK IRELAND LTD G31520 00827002315204

    Patients

    Seq Age Sex Outcome Treatment
    1