BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE

    MDR report key: 8850175 · Received August 1, 2019

    Report

    Report Number
    3001845648-2019-00380
    Event Type
    Malfunction
    Date Received
    August 1, 2019
    Date of Event
    July 3, 2019
    Report Date
    August 1, 2019
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FCG
    UDI-DI
    00827002315204
    PMA / PMN Number
    K083330
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) # K083330. 1 X ECHO-19 OF LOT # C1594572 WAS RETURNED TO CIRL FOR EVALUATION OPEN IN ITS 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. THE TIP OF THE NEEDLE WAS FOUND TO BE DEFORMED/BENT. 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. A REVIEW OF THE MANUFACTURING RECORDS FOR ECHO-19 OF LOT NUMBER C1594572 DID NOT REVEAL ANY DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. THE NOTES SECTION OF THE INSTRUCTIONS FOR USE, WHICH ACCOMPANIES THIS DEVICE INSTRUCTS THE USER TO; "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. THE FAILURE OF NEEDLE KINKED/BENT WAS OBSERVED IN THE LABORATORY. 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 ADVANCEMENT INTO A HARD LESION. 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

    THEY CHECKED THAT MASS LOCATION WAS BODY OF PANCREAS BEFORE THE PROCEDURE IN EUS. THEY ADVANCED ECHO-19 TO MASS IN THROUGH THE SCOPE. HOWEVER, THE NEEDLE DIDN'T FUNCTURE TO MASS IN EUS. CONSEQUENTLY, THE NEEDLE REMOVED OUT OF THE SCOPE.SO THEY USED ANOTHER ECHO-19.

    Additional Manufacturer Narrative · 1

    PMA/510(K) # K083330. INVESTIGATION IS STILL PENDING. A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Description of Event or Problem · 1

    THEY CHECKED THAT MASS LOCATION WAS BODY OF PANCREAS BEFORE THE PROCEDURE IN EUS. THEY ADVANCED ECHO-19 TO MASS IN THROUGH THE SCOPE. HOWEVER, THE NEEDLE DIDN'T PUNCTURE TO MASS IN EUS. CONSEQUENTLY, THE NEEDLE REMOVED OUT OF THE SCOPE. SO THEY USED ANOTHER ECHO-19.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    646110 ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE FCG KIT, NEEDLE, BIOPSY FCG COOK IRELAND LTD G31520 C1594572 00827002315204

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR