BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHOTIP PROCORE ENDOBRONCHIAL HD BIOPSY NEEDLE

    MDR report key: 12133323 · Received July 8, 2021

    Report

    Report Number
    3001845648-2021-00545
    Event Type
    Injury
    Date Received
    July 8, 2021
    Date of Event
    June 8, 2021
    Report Date
    September 20, 2021
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FCG
    UDI-DI
    10827002342795
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    510(K) NUMBER: K160229. 1 UNIT OF LOT C1591140 OF ECHO-HD-22-EBUS-P-C WAS RETURNED OPENED 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. IN SUMMARY THE FOLLOWING RESULTS WERE OBSERVED IN THE LAB EVALUATION: THE DISTAL END OF THE NEEDLE WAS FOUND TO BE BROKEN AND KINKED. DISTAL END OF NEEDLE WAS RETURNED SEPARATELY. SHEATHE EXTENDER ABLE TO ADVANCE AND RETRACT. NEEDLE ABLE TO ADVANCE AND RETRACT. PRIOR TO DISTRIBUTION, ALL ECHO-HD-22-EBUS-P-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-22-EBUS-P-C OF LOT NUMBER C1591140 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. 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 IS DIFFICULT TO DETERMINE BUT COULD BE ATTRIBUTED TO ADVANCEMENT INTO A HARD LESION OR THROUGH HARD TISSUE SUCH AS CARTILAGE CAUSING THE DISTAL TIP OF THE NEEDLE TO BREAK. IT IS ALSO POSSIBLY THAT THE NEEDLE MAY HAVE JERKED WHEN THE DISTAL END OF THE NEEDLE BROKE, POTENTIALLY CAUSING PRESSURE BACK UP THE NEEDLE RESULTING IN THE DISTAL KINK. COMPLAINT IS CONFIRMED AS THE FAILURE WAS VERIFIED IN THE LABORATORY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    510(K) NUMBER: K160229. 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 COMPLETION OF THE INVESTIGATION AND AN UPDATE TO THE INVESTIGATION CONCLUSIONS.

    Description of Event or Problem · 0

    THE DEVICE WAS RETURNED AND EVALUATED ON THE 22-JUL, THIS SUPPLEMENT REPORT IS BEING SUBMITTED TO REFLECT THIS IN SECTION F & H OF THE REPORT.

    Additional Manufacturer Narrative · 1

    510(K) NUMBER: K160229. THE INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Description of Event or Problem · 1

    USER ADVANCED THE DEVICE TO RIGHT LUNG THEN ADVANCED THE NEEDLE WHILE FOUND OUT THE NEEDLE BROKEN. USER IMMEDIATELY PICKED THE BROKEN NEEDLE OUT FROM PATIENT PREVENT MASSIVE BLEEDING. "A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENTS BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. IF THE REPORT INVOLVES A KINK OR BEND IN THE NEEDLE, WHERE IS THIS LOCATED ON THE DEVICE (HANDLE END (PROXIMAL END) OR PATIENT END (DISTAL END))? PLEASE DESCRIBE THE LOCATION IN THE BODY FOR THE INTENDED TARGET SITE (PANCREAS, STOMACH, LUNGS ETC.). A. IF THE LUNGS, WHICH LYMPH NODE WAS BEING TARGETED? E.G. 2R, 2L, 4R, AO, AR, 11RI, 11S ETC. B. 2R, 2L, 4R, AO, AR, 11RI, 11S. PLEASE DESCRIBE THE SIZE OF THE INTENDED TARGET SITE. IF NOT WITH THE DEVICE IN QUESTION, HOW WAS THE PROCEDURE PERFORMED AND/OR FINISHED? WAS THE DEVICE USED IN A TORTUOUS POSITION? ARE IMAGES OF THE DEVICE OR PROCEDURE AVAILABLE? WAS IT DAMAGED IN PACKAGING BEFORE REMOVAL? WAS IT DAMAGED ON REMOVAL FROM PACKAGING? WAS FORCE REQUIRED TO REMOVE THE DEVICE? FOR COMPLAINTS OCCURRING DURING USE (ONCE IN CONTACT WITH ENDOSCOPE) ALSO ASK: WHAT IS THE ENDOSCOPE MANUFACTURER AND MODEL NUMBER THAT WAS USED? WAS FORCE REQUIRED ON INSERTION OF DEVICE INTO SCOPE? WHEN WAS THE ISSUED NOTED? E.G. ON ADVANCEMENT OF THE SHEATH/NEEDLE OR ON NEEDLE RETRACTION? 13. WAS DIFFICULTY EXPERIENCED WHILE RETRACTING THE NEEDLE? WAS THE SYRINGE USED DURING THE PROCEDURE, AFTER THE STYLET WAS REMOVED? WAS THE NEEDLE ABLE TO BE FULLY RETRACTED BEFORE REMOVING FROM THE PATIENT? WAS GAINING ACCESS TO THE TARGETED SITE DIFFICULT? WAS THE ENDOSCOPE IN A FLEXED OR TWISTED POSITION AT ANY TIME DURING THE PROCEDURE? WAS NEEDLE PENETRATION OF THE TARGETED SITE DIFFICULT? WAS THE STYLET PARTIALLY REMOVED PRIOR TO ADVANCEMENT OF NEEDLE? HOW MANY BIOPSIES/PASSES WERE OBTAINED WITH USE OF THIS NEEDLE? DID ANY SECTION OF THE DEVICE DETACH INSIDE THE PATIENT? IF KINKED BELOW THE SHEATH EXTENDER, DID THEY NOTICE THE KINK BEFORE PLACING THE DEVICE INTO THE SCOPE? WAS THERE DIFFICULTY OR SLIPPING EXPERIENCED OF THE SHEATH EXTENDER OR LOCK RING DURING USE? WAS THERE DIFFICULTY IN ATTACHMENT / DETACHMENT OF THE LEUR TO THE SCOPE? IF THE DEVICE IS PROCORE AND IT IS KINKED DISTALLY, IS THE KINK AT THE NOTCH / CORE TRAP? PROCORE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1035080 ECHOTIP PROCORE ENDOBRONCHIAL HD BIOPSY NEEDLE FCG KIT, NEEDLE, BIOPSY FCG COOK IRELAND LTD C1591140 10827002342795

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention