BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE

    MDR report key: 7906154 · Received September 25, 2018

    Report

    Report Number
    3001845648-2018-00442
    Event Type
    Malfunction
    Date Received
    September 25, 2018
    Date of Event
    August 27, 2018
    Report Date
    September 24, 2018
    Manufacturer
    COOK INC
    Product Code
    FCG
    UDI-DI
    00827002315198
    PMA / PMN Number
    K083330
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    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: K851962. 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 CLSO-10-7 DEVICE OF LOT C1476463 INVOLVED IN THIS COMPLAINT WAS RETURNED FOR EVALUATION, OPENED BUT WITH THE ORIGINAL PACKAGING. WITH THE INFORMATION PROVIDED, A PHYSICAL EXAMINATION AND DOCUMENT BASED INVESTIGATION WAS CONDUCTED. THE DEVICE RELATED TO THIS OCCURRENCE UNDERWENT A LABORATORY EVALUATION ON THE (B)(6) 2018. IT SHOULD BE NOTED THAT THE CUSTOMER STATED IN ADDITIONAL INFORMATION THAT A 7 FRENCH PUSHING CATHETER (PC-7 WAS USED TO PUSH THE STENT, HOWEVER THE PC-7 IS NOT COMPATIBLE WITH THE CLSO-10-7 THEREFORE IT WOULD NOT BE ABLE TO PUSH THE STENT PASSED THE STRICTURE. THE COMPLAINT IS CONFIRMED AS USER ERROR BASED ON CUSTOMER TESTIMONY. THE RELEVANT COOK PRODUCT MANAGER HAS BEEN CONTACTED TO OFFER RETRAINING TO THE CUSTOMER INVOLVED IN THIS COMPLAINT, TO PREVENT FUTURE OCCURRENCE DOCUMENTS REVIEW: A REVIEW OF THE MANUFACTURING RECORDS FOR THE CLSO-10-7 OF LOT C1476463 DID NOT REVEAL ANY DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT. UPON REVIEW OF THE COMPLAINTS HISTORY, THIS FAILURE HAS NOT OCCURRED PREVIOUSLY WITH THIS LOT. PRIOR TO DISTRIBUTION, ALL CLSO-10-7 DEVICES ARE SUBJECT TO VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. THERE IS ALSO A VISUAL INSPECTION OF THE PRODUCT AND PACKAGING AT PACKAGING, PACKAGING QC, AND POST STERILE QC. IT SHOULD BE NOTED THAT THIS COMPLAINT IS NOT RELATED TO A DEVICE MALFUNCTION, THIS COMPLAINT IS RELATED TO USER ERROR. IFU REVIEW: IT SHOULD BE NOTED THAT AS PER THE INSTRUCTIONS FOR USE (IFU0045-6) PRECAUTIONS SECTION THE USER IS INSTRUCTED TO "SELECT THE COOK INTRODUCER SYSTEM(IF NOT INCLUDED) IN THE APPROPRIATE FRENCH SIZE" AND IN THE CONTRAINDICATIONS SECTION THE USER IS ADVISED THAT "AN INABILITY TO PASS WIRE OR STENT THROUGH THE OBSTRUCTED AREA" IS CONTRAINDICATED. ROOT CAUSE: A POSSIBLE ROOT CAUSE OF USER ERROR AS PER THE EVIDENCE RECEIVED IN THE CUSTOMER ADDITIONAL INFORMATION. THE CUSTOMER STATED IN ADDITIONAL INFORMATION RECEIVED THAT A 7 FRENCH SIZED PUSHING CATHETER WAS USED TO PUSH THE 10 FRENCH SIZED STENT, HOWEVER THESE DEVICES ARE NOT COMPATIBLE THEREFORE IT WAS NOT POSSIBLE TO PUSH THE STENT. THE PRODUCT MANAGER HAS BEEN CONTACTED TO OFFER RETRAINING TO THE CUSTOMER TO PREVENT FURTHER OCCURRENCE. SUMMARY THE COMPLAINT IS CONFIRMED AS USER ERROR BASED ON CUSTOMER TESTIMONY. THE RISK WAS DETERMINED TO BE NO RISK (CATEGORY III). ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Description of Event or Problem · 0

    AS REPORTED TO CUSTOMER RELATIONS, "IT CAME OUT OF THE PACKAGE WITH A KINK IN THE SHEATH AND THE NEEDLE WOULD NOT ADVANCE. THEY OPENED ANOTHER DEVICE TO COMPLETE THE PROCEDURE SUCCESSFULLY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    748373 ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE FCG KIT, NEEDLE, BIOPSY FCG COOK INC G31519 C1448439 00827002315198

    Patients

    Seq Age Sex Outcome Treatment
    1