BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHOTIP ULTRA HIGH DEFINITION ULTRASOUND ACCESS NEEDLE

    MDR report key: 9149660 · Received October 3, 2019

    Report

    Report Number
    3001845648-2019-00503
    Event Type
    Malfunction
    Date Received
    October 3, 2019
    Date of Event
    August 13, 2019
    Report Date
    September 4, 2019
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FCG
    UDI-DI
    00827002520127
    PMA / PMN Number
    K092359
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PMA/510(K) #K092359. 1 UNIT OF LOT NUMBER C1572180 OF ECHO-HD-19-A WAS RETURNED OPENED IN ITS ORIGINAL PACKAGING. THE DEVICE RELATED TO THIS OCCURRENCE UNDERWENT A LABORATORY EVALUATION. THE TIP OF THE SHEATH WAS OBSERVED TO BE DAMAGED. THE NEEDLE WAS ABLE TO BE ADVANCED AND RETRACTED WITHOUT ISSUE. NO ISSUE OBSERVED WITH THE NEEDLE TIP. 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 C1572180 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 C1572180. THE NOTES SECTION OF THE INSTRUCTIONS FOR USE, 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. 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 A COMBINATION OF TORTUOUS POSITION AND FLEXED OR TWISTED ENDOSCOPE POSITION AS INDICATED IN THE ADDITIONAL INFORMATION WHICH MAY HAVE CAUSED ISSUES ADVANCING THE NEEDLE AND POSSIBLY THEN RESULTED IN THE NEEDLE/STYLET DAMAGING THE SHEATH. COMPLAINT IS CONFIRMED BASED ON THE CUSTOMER'S TESTIMONY. 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 · 1

    USER ADVANCE THE DEVICE TO STOMACH BUT FOUND OUT THE NEEDLE CANNOT BE ADVANCED FROM SHEATH. USER RETRACTED THE DEVICE FROM PATIENT AND FOUND OUT THE TIP OF NEEDLE SLIGHTLY BENT WHICH CAUSE THE ADVANCEMENT DIFFICULTY. USER CHANGED ANOTHER SAME DEVICE TO COMPLETE THE PROCEDURE. DEVICE WAS RETURNED AND EVALUATED ON 04-SEP-2019 AND THE TIP OF THE SHEATH WAS NOTED TO BE DAMAGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    944894 ECHOTIP ULTRA HIGH DEFINITION ULTRASOUND ACCESS NEEDLE FCG KIT, NEEDLE, BIOPSY FCG COOK IRELAND LTD G52012 C1572180 00827002520127

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR