BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE

    MDR report key: 11963924 · Received June 9, 2021

    Report

    Report Number
    3001845648-2021-00443
    Event Type
    Malfunction
    Date Received
    June 9, 2021
    Date of Event
    April 2, 2021
    Report Date
    June 10, 2021
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FCG
    UDI-DI
    10827002347851
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    510(K) CODE: K142688. 1 UNIT OF LOT C1782691 OF ECHO-HD-3-20-C WAS RETURNED OPENED IN THE ORIGINAL PACKAGING. THE DEVICE INVOLVED IN THE COMPLAINT WAS EVALUATED IN THE LABORATORY ON 10 JUNE 2021. A DISTAL NEEDLE BREAK WAS OBSERVED. 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 C1782691 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 C1782691. 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 . 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 THE DISTAL PART OF THE NEEDLE BREAKING POSSIBLE DUE TO THE ACTUAL LESION COULD HAVE BEEN HARD CAUSING THE NEEDLE TO BREAK COMPLAINT IS CONFIRMED AS THE FAILURE WAS VERIFIED IN THE LABORATORY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    510(K) CODE: K142688. THE INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Description of Event or Problem · 0

    SUPPLEMENTAL FOLLOW-UP REPORT IS BEING SUBMITTED DUE TO THE RECEIPT AND EVALUATION OF THE COMPLAINT DEVICE, COMPLETION OF THE INVESTIGATION AND AN UPDATE TO THE INVESTIGATION CONCLUSIONS. INITIAL REPORT DETAILS: USER CONDUCT THE BIOPSY THROUGH STOMACH, THE NEEDLE BROKEN AT SECOND ATTEMPT. "A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE." 1. IF THE REPORT INVOLVES A KINK OR BEND IN THE NEEDLE, WHERE IS THIS LOCATED ON THE DEVICE (HANDLE END OR PATIENT END)? NO. 2. PLEASE DESCRIBE THE LOCATION IN THE BODY FOR THE INTENDED TARGET SITE (PANCREAS, STOMACH, ETC). BODY OF PANCREAS 3. PLEASE DESCRIBE THE SIZE OF THE INTENDED TARGET SITE.48MMX24MM. 4. WHAT IS THE ENDOSCOPE MANUFACTURER AND MODEL NUMBER THAT WAS USED WITH THIS DEVICE? OLYMPUS GF-UCT260. 5. WAS GAINING ACCESS TO THE TARGETED SITE DIFFICULT? NO. 6. WAS THE ENDOSCOPE IN A FLEXED OR TWISTED POSITION AT ANY TIME DURING THE PROCEDURE? NO. 7. WAS NEEDLE PENETRATION OF THE TARGETED SITE DIFFICULT? NO. 8. WAS THE STYLET IN PLACE INSIDE THE NEEDLE WHEN ADVANCING INTO THE TARGETED SITE? YES. 9. HOW MANY BIOPSIES WERE OBTAINED WITH USE OF THIS NEEDLE? 2. 10. DID ANY SECTION OF THE DEVICE DETACH INSIDE THE PATIENT? NO. 11. IF NOT WITH THE DEVICE IN QUESTION, HOW WAS THE PROCEDURE PERFORMED AND/OR FINISHED? WITH ANOTHER SAME DEVICE TO COMPLETE THE PROCEDURE.

    Description of Event or Problem · 0

    USER CONDUCT THE BIOPSY THROUGH STOMACH, THE NEEDLE BROKEN AT SECOND ATTEMPT. "A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE." IF THE REPORT INVOLVES A KINK OR BEND IN THE NEEDLE, WHERE IS THIS LOCATED ON THE DEVICE (HANDLE END OR PATIENT END)? NO. PLEASE DESCRIBE THE LOCATION IN THE BODY FOR THE INTENDED TARGET SITE (PANCREAS, STOMACH, ETC). BODY OF PANCREAS . PLEASE DESCRIBE THE SIZE OF THE INTENDED TARGET SITE.48MMX24MM . WHAT IS THE ENDOSCOPE MANUFACTURER AND MODEL NUMBER THAT WAS USED WITH THIS DEVICE? OLYMPUS GF-UCT260 . WAS GAINING ACCESS TO THE TARGETED SITE DIFFICULT? NO. . WAS THE ENDOSCOPE IN A FLEXED OR TWISTED POSITION AT ANY TIME DURING THE PROCEDURE? NO. WAS NEEDLE PENETRATION OF THE TARGETED SITE DIFFICULT? NO. . WAS THE STYLET IN PLACE INSIDE THE NEEDLE WHEN ADVANCING INTO THE TARGETED SITE? YES . HOW MANY BIOPSIES WERE OBTAINED WITH USE OF THIS NEEDLE? 2 . DID ANY SECTION OF THE DEVICE DETACH INSIDE THE PATIENT? NO. . IF NOT WITH THE DEVICE IN QUESTION, HOW WAS THE PROCEDURE PERFORMED AND/OR FINISHED? WITH ANOTHER SAME DEVICE TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    863003 ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE FCG KIT, NEEDLE, BIOPSY FCG COOK IRELAND LTD C1782691 10827002347851

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR