BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHOTIP PROCORE ENDOBRONCHIAL HD BIOPSY NEEDLE

    MDR report key: 12480273 · Received September 16, 2021

    Report

    Report Number
    3001845648-2021-00678
    Event Type
    Injury
    Date Received
    September 16, 2021
    Date of Event
    August 17, 2021
    Report Date
    November 9, 2021
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FCG
    UDI-DI
    10827002342795
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) #: K160229. COMPLAINT DEVICE WAS NOT RETURNED THEREFORE, A DOCUMENT BASED REVIEW WILL BE PERFORMED. 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 C1810465 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 C1810465. 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 COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. 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. COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. IT WAS CONFIRMED THAT THE BROKEN NEEDLE TIP WAS RETRIEVED AND NO METAL WAS LEFT BEHIND. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    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.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    AS REPORTED TO CUSTOMER RELATIONS VIA COMPLAINT FORM, ""SLIVER OF METAL BROKE OFF" UNDETERMINED IF IT WAS TIP OF NEEDLE OR STYLET. DEVICE HAS BEEN DISPOSED OF PRIOR TO NOTIFYING THE REP. ACTION TAKEN WAS IN-SERVICE OF DEVICE AND BEST PRACTICES TO TROUBLESHOOT EBUS NEEDLES." THIS IS A CONSERVATIVE ASSESSMENT SINCE IT HAS NOT YET BEEN CONFIRMED WHETHER IT WAS THE NEEDLE OR STYLET THAT BROKE, CLARIFICATION HAS BEEN REQUESTED. DID ANY SECTION OF THE DEVICE REMAIN INSIDE THE PATIENT¿S BODY? NO. PLEASE DESCRIBE THE OBJECT AND HOW IT WAS RETRIEVED: DID THE PATIENT EXPERIENCE A DELAY OR REQUIRE ANY ADDITIONAL PROCEDURE DUE TO THIS OCCURRENCE? NO. PLEASE SPECIFY DELAY OR ANY ADDITIONAL PROCEDURE(S) AND PROVIDE DETAILS: HAS THE COMPLAINANT REPORTED ANY ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE? NO. HAS THE COMPLAINANT REPORTED THAT THE PRODUCT CAUSED OR CONTRIBUTED TO THE ADVERSE EFFECTS? NO. PLEASE SPECIFY ADVERSE EFFECTS AND PROVIDE DETAILS. FOR ALL COMPLAINTS, ASK: ARE IMAGES OF THE DEVICE OR PROCEDURE AVAILABLE? N/A, YES, NO 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))? N/A, HANDLE END, PATIENT END WERE ANY OTHER DEFECTS (OTHER THAN THE COMPLAINT ISSUE) OBSERVED ON THE DEVICE PRIOR TO RETURN (E.G. KINK)? N/A, YES, NO PLEASE SPECIFY IF YES. IF THE DEVICE WAS KINKED BELOW THE SHEATH EXTENDER, WAS THE KINK OBSERVED BEFORE INSERTING THE DEVICE INTO THE SCOPE? N/A, YES, NO IF THE DEVICE IS A PROCORE NEEDLE, IS THE DEVICE DAMAGE LOCATED AT THE NOTCH / CORE TRAP? N/A, YES, NO IF NO, PLEASE SPECIFY WHERE THE DAMAGE IS LOCATED: WAS GAINING ACCESS TO THE TARGET SITE DIFFICULT? N/A, YES, NO WAS THE DEVICE USED IN A TORTUOUS POSITION? N/A, YES, NO WAS PUNCTURE OF THE TARGET SITE DIFFICULT? N/A, YES, NO PLEASE DESCRIBE THE ANATOMICAL LOCATION OF THE INTENDED TARGET SITE (PANCREAS, STOMACH, LUNGS ETC.). IF THE LUNGS, WHICH LYMPH NODE WAS BEING TARGETED? E.G. 4R, 11R, 12L ETC. 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 DAMAGED IN PACKAGING PRIOR TO REMOVAL? N/A, YES, NO WAS THE DEVICE DAMAGED ON REMOVAL FROM PACKAGING? N/A, YES, NO WAS FORCE REQUIRED TO REMOVE THE DEVICE? N/A, YES, NO DID THE PATIENT REQUIRE ANY ADDITIONAL PROCEDURES AS A RESULT OF THIS EVENT? N/A, YES, NO WHAT INTERVENTION (IF ANY) WAS REQUIRED? WAS THE SECONDARY INTERVENTION PERFORMED DURING THE SAME PROCEDURE AS THE DEVICE FAILURE OR WAS IT SCHEDULED FOR ANOTHER DAY? N/A, SAME PROCEDURE, ANOTHER DAY WERE ANY OTHER DEFECTS OBSERVED ON THE DEVICE PRIOR TO RETURN (E.G. KINKS, BENDS, BREAKS ETC.)? N/A, YES, NO IF YES, PLEASE SPECIFY WHAT WAS OBSERVED AND WHERE ON THE DEVICE IT WAS OBSERVED. WHAT IS THE SCOPE MANUFACTURER AND MODEL NUMBER THAT WAS USED? WAS RESISTANCE FELT WHILE INSERTING THE DEVICE THROUGH THE SCOPE? N/A, YES, NO WAS THE SCOPE RECENTLY SERVICED / REPAIRED? N/A, YES, NO WHEN WAS THE ISSUED WITH THE PRODUCT NOTED? ON ADVANCEMENT OF THE SHEATH/NEEDLE OR ON NEEDLE RETRACTION? WAS THE SYRINGE USED DURING THE PROCEDURE, AFTER THE STYLET WAS REMOVED? N/A, YES, NO WAS DIFFICULTY EXPERIENCED WHILE RETRACTING THE NEEDLE? N/A, YES, NO WAS IT POSSIBLE TO FULLY RETRACT THE NEEDLE INTO THE SHEATH BEFORE REMOVING THE DEVICE FROM THE PATIENT? N/A, YES, NO WAS THE ENDOSCOPE IN A FLEXED OR TWISTED POSITION AT ANY TIME DURING THE PROCEDURE? N/A, YES, NO WAS THE STYLET PARTIALLY REMOVED WHEN ADVANCING THE NEEDLE INTO THE TARGET SITE? N/A, YES, NO HOW MANY SAMPLES WERE OBTAINED (PASSES COMPLETED) WITH THIS NEEDLE? DID ANY SECTION OF THE DEVICE DETACH INSIDE THE PATIENT? N/A, YES, NO IF YES, PLEASE SPECIFY: WAS THERE DIFFICULTY LOCKING THE SHEATH (OR NEEDLE) IN PLACE OR SLIPPING EXPERIENCED DURING USE? N/A, YES, NO WAS THERE DIFFICULTY IN ATTACHING OR DETACHING THE DEVICE TO THE ACCESSORY CHANNEL PORT ON THE SCOPE? N/A, YES, NO WHEN THE NEEDLE TIP WAS ADVANCED INTO THE TARGET SITE WAS THE DISTAL SCOPE POSITION ADJUSTED SO AS TO STRAIN OR FLEX THE NEEDLE? N/A, YES, NO IF AN EBUS PROCEDURE DID THE NEEDLE TIP HIT THE CARTILAGE RINGS OF THE TRACHEA?

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1379685 ECHOTIP PROCORE ENDOBRONCHIAL HD BIOPSY NEEDLE FCG KIT, NEEDLE, BIOPSY FCG COOK IRELAND LTD C1810465 10827002342795

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention