BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE

    MDR report key: 10033557 · Received May 7, 2020

    Report

    Report Number
    3001845648-2020-00290
    Event Type
    Injury
    Date Received
    May 7, 2020
    Date of Event
    April 10, 2020
    Report Date
    May 7, 2020
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FCG
    UDI-DI
    10827002347851
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) # K142688. DEVICE EVALUATION: 1 UNIT OF LOT C1689829 OF ECHO-HD-3-20-C WAS RETURNED OPENED IN ITS ORIGINAL PACKAGING. LAB EVALUATION: THE DEVICE RELATED TO THIS OCCURRENCE UNDERWENT A LABORATORY EVALUATION ON (B)(6) 2020. THE NEEDLE WAS FOUND TO BE BROKEN PROXIMALLY APPROX. 48.5CM FROM BASE OF THE HUB. TWO KINKS WERE OBSERVED BELOW THE SHEATH EXTENDER APPROX. 26.5CM AND 28CM FROM BASE OF HUB. THE DISTAL END OF THE NEEDLE WAS OBSERVED TO BE KINKED/DAMAGED APPROX. 7CM FROM THE NEEDLE TIP. CLARIFICATION WAS REQUESTED AS FOLLOWS; ¿THE KINK IN THE PHOTO BELOW WAS OBSERVED IN THE BROKEN NEEDLE SECTION RETURNED DETACHED FROM THE DEVICE. IT WAS OBSERVED APPROX. 7CM FROM THE TIP OF THE NEEDLE. CAN YOU PLEASE CHECK IF THIS KINK WOULD HAVE BEEN CAUSED BY REMOVAL OF THIS PART OF THE NEEDLE FROM THE PATIENT BY FORCEPS¿ REPLY WAS RECEIVED AS FOLLOWS; ¿THERE REMOVAL OF END PART OF THE NEEDLE FROM THE PATIENT BY FORCEPS. I THINK THERE WAS A KINK DURING THE TRANSPORT AND REMOVAL PROCEDURE¿ DOCUMENT REVIEW INCLUDING IFU REVIEW: PRIOR TO DISTRIBUTION, ALL ECHO-HD-3-20-C 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-3-20-C OF LOT NUMBER C1689829 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 C1689829. THE NOTES SECTION OF THE INSTRUCTIONS FOR USE, IFU0077-4, WHICH ACCOMPANIES THIS DEVICE INSTRUCTS THE USER TO INSPECT THE DEVICE PRIOR TO USE : "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 (IFU0077-4). ROOT CAUSE REVIEW 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 EXCESSIVE FORCE WHICH CAN BE APPLIED WHEN TRYING TO GET THE NEEDLE OUT OF THE SCOPE DURING ADVANCEMENT. THIS COULD HAVE POTENTIALLY CAUSED THE NEEDLE BREAKAGE AND THE TWO KINKS 26.5CM AND 28CM FROM THE BASE OF THE HUB. THE KINK OBSERVED APPROX. 7CM FROM THE NEEDLE TIP WOULD LIKELY HAVE BEEN CAUSED BY REMOVING THE BROKEN NEEDLE SECTION BY FORCEPS AND TRANSPORT RETURNS SUMMARY 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. THE REMAINED DEVICE WAS REMOVED WITH THE FORCEPS. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    DURING FNB OPERATION , THE STAINLESS SHEATH BROKE. IN DETAIL, WHEN DR.JO WAS PUNCTURING THE BODY OF PANCREAS FROM STOMACH, 50CM OF DISTAL STAINLESS SHEATH WAS BROKEN AND THEN THE NEEDLES WAS EMBEDDED IN THE STOMACH. AND HE REMOVED THE BROKEN PART WITH THE FORCEPS.

    Additional Manufacturer Narrative · 1

    PMA/510(K) # K142688. INVESTIGATION IS STILL PENDING. A FOLLOW-UP /FINAL VIGILANCE REPORT WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Description of Event or Problem · 1

    DURING FNB OPERATION , THE STAINLESS SHEATH BROKE. IN DETAIL, WHEN DR. (B)(6) WAS PUNCTURING THE BODY OF PANCREAS FROM STOMACH, 50CM OF DISTAL STAINLESS SHEATH WAS BROKEN AND THEN THE NEEDLES WAS EMBEDDED IN THE STOMACH. AND HE REMOVED THE BROKEN PART WITH THE FORCEPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    499401 ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE FCG KIT, NEEDLE, BIOPSY FCG COOK IRELAND LTD C1689829 10827002347851

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention