BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE

    MDR report key: 17841322 · Received September 29, 2023

    Report

    Report Number
    3001845648-2023-00746
    Event Type
    Injury
    Date Received
    September 29, 2023
    Date of Event
    August 22, 2023
    Report Date
    December 7, 2023
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FCG
    UDI-DI
    10827002347851
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) # K210476. INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Additional Manufacturer Narrative · 0

    PMA/510(K) # K210476. DEVICE EVALUATION: 1 UNIT OF LOT NUMBER C1996056 OF ECHO-HD-3-20-C WAS RETURNED OPENED IN ITS ORIGINAL PACKAGING. WITH THE INFORMATION PROVIDED, A PHYSICAL EXAMINATION AND DOCUMENT BASED INVESTIGATION WAS CONDUCTED. THE DEVICE INVOLVED IN THE COMPLAINT WAS EVALUATED IN THE LABORATORY ON 26 SEP 2023. THE RETURNED DEVICE LAB FINDINGS AND OBSERVATIONS CAN BE REFERRED THROUGH THE ATTACHED FILES. VISUAL INSPECTION: DISTAL END OF NEEDLE EXAMINED, AND NO ISSUE OBSERVED. NEEDLE REMOVED FROM DEVICE AND BREAK OBSERVED BELOW THE SHEATH EXTENDER FUNCTIONAL INSPECTION: SHEATH EXTENDER ABLE TO ADVANCE AND RETRACT WITHOUT ISSUE. NEEDLE HANDLE ABLE TO ADVANCE AND RETRACT WITHOUT ISSUE BUT NEEDLE DID NOT RETRACT WHEN HANDLE RETRACTED. MANUFACTURING RECORDS: PRIOR TO DISTRIBUTION, ALL ECHO-HD-3-20-C DEVICES ARE SUBJECTED TO FUNCTIONAL CHECKS AND VISUAL INSPECTION TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE MANUFACTURING RECORDS FOR ECHO-HD-3-20-C DEVICE OF LOT NUMBER C1996056 DID NOT REVEAL ANY DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. REVIEW HISTORICAL DATA: A REVIEW OF THE MANUFACTURING RECORDS FOR THE ECHO-HD-3-20-C DEVICE 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 C1996056. INSTRUCTIONS FOR USE AND LABEL: THE NOTES SECTION OF THE INSTRUCTIONS FOR USE (IFU0077), 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) IMAGE REVIEW: AN IMAGE WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE ANALYSIS: A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO THE ENDOSCOPE BEING USED IN A SLIGHTLY FLEXED/TWISTED POSITION AS INDICATED BY THE ADDITIONAL INFORMATION WHICH BECAME EXACERBATED AFTER THE TWO SUCCESSFUL PASSES CAUSING THE NEEDLE TO BREAK DURING THE THIRD PASS. ANOTHER POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO EXCESSIVE FORCE WHICH MAY HAVE BEEN APPLIED WHEN TRYING TO RETRACT THE NEEDLE INTO THE SCOPE DURING THE THIRD PASS LEADING TO THE PROXIMAL BREAK. CONFIRMATION OF COMPLAINT: COMPLAINT IS CONFIRMED BASED ON VISUAL AND/OR FUNCTIONAL INSPECTION. CORRECTIVE ACTION/CORRECTION: COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS. SUMMARY OF INVESTIGATION: ACCORDING TO THE CUSTOMER, NEEDLE BROKEN. CONFIRMED QUANTITY OF 1 DEVICE, CONFIRMED USED. ACCORDING TO THE INITIAL REPORT, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. INVESTIGATION FINDINGS CONCLUDE THAT A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO THE ENDOSCOPE BEING USED IN A SLIGHTLY FLEXED/TWISTED POSITION AS INDICATED BY THE ADDITIONAL INFORMATION WHICH BECAME EXACERBATED AFTER THE TWO SUCCESSFUL PASSES CAUSING THE NEEDLE TO BREAK DURING THE THIRD PASS. ANOTHER POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO EXCESSIVE FORCE WHICH MAY HAVE BEEN APPLIED WHEN TRYING TO GET THE NEEDLE OUT OF THE SCOPE DURING ADVANCEMENT FOR THE THIRD PASS POTENTIALLY CAUSING THE NEEDLE TO BREAK.

    Description of Event or Problem · 0

    USER DETECTED THE NEEDLE BROKE DURING THIRD BIOPSY AND THE NEEDLE CANNOT BE RETRACTED. 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)? HANDLE END. 2. PLEASE DESCRIBE THE LOCATION IN THE BODY FOR THE INTENDED TARGET SITE (PANCREAS, STOMACH, ETC). PANCREAS. 3. PLEASE DESCRIBE THE SIZE OF THE INTENDED TARGET SITE. DIAMETER 1.2MM. 4. WHAT IS THE ENDOSCOPE MANUFACTURER AND MODEL NUMBER THAT WAS USED WITH THIS DEVICE? OLYMPUS TJF-260V. 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? 3. 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

    SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 07-DEC-2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2277419 ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE FCG KIT, NEEDLE, BIOPSY FCG COOK IRELAND LTD C1996056 10827002347851

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female Required Intervention