BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHOTIP PROCORE ENDOBRONCHIAL HD BIOPSY NEEDLE

    MDR report key: 10913579 · Received November 27, 2020

    Report

    Report Number
    3001845648-2020-00897
    Event Type
    Injury
    Date Received
    November 27, 2020
    Date of Event
    October 28, 2020
    Report Date
    January 28, 2021
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FCG
    UDI-DI
    10827002342818
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    510(K) NUMBER: K160229. DEVICE EVALUATION 1 UNIT OF LOT C1755687 OF ECHO-HD-22-EBUS-O-C WAS RETURNED OPENED NOT IN ITS ORIGINAL PACKAGING . LAB EVALUATION. THE DEVICE INVOLVED IN THE COMPLAINT WAS EVALUATED IN THE LABORATORY ON 03 DEC 2020. THE NEEDLE WAS BROKEN AT THE NOTCH AREA. DOCUMENT REVIEW INCLUDING IFU REVIEW. PRIOR TO DISTRIBUTION, ALL ECHO-HD-22-EBUS-O-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-O-C OF LOT NUMBER C1755687 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 C1755687. THE INSTRUCTIONS FOR USE, IFU0109-6 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 (IFU0109-6) 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 HARD LESION IN PARTS LEADING TO EVENTUAL NEEDLE BREAK AFTER MULTIPLE SAMPLES WERE TAKEN OR NEEDLE DAMAGED DURING USE LEADING TO BREAK ON PUNCTURE OR TRACHEAL RING (HARD CARTILAGE) WAS PASSED. 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. THE USER WAS ABLE TO RETRIEVE THE NEEDLE PORTION VIA SUCTIONING. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    THE DEVICE WAS EVALUATED ON THE 03-DEC-2020, THIS SUPPLEMENT REPORT IS BEING SUBMITTED TO CAPTURE THE DEVICE EVALUATION WITHIN SECTION D AND H.

    Description of Event or Problem · 0

    THE INVESTIGATION WAS CONCLUDED ON THE (B)(6) 2021, THIS SUPPLEMENT REPORT IS BEING SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS WITHIN SECTION H.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE TIP OF THE NEEDLE BROKE OFF IN THE PATIENT'S LUNG. THE USER WAS ABLE TO RETRIEVE THE NEEDLE PORTION VIA SUCTIONING. DID ANY UNINTENDED SECTION OF THE DEVICE REMAIN INSIDE THE PATIENT¿S BODY? NO. WAS THE PATIENT HOSPITALIZED OR WAS THERE PROLONGED HOSPITALIZATION? NO. DID THE PATIENT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE? DEVICE PORTION WAS SUCTIONED OUT OF PATIENT. DID THE PRODUCT CAUSE OR CONTRIBUTE TO THE NEED FOR ADDITIONAL PROCEDURES? YES. 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? NA. ANSWERS RECEIVED 09NOV2020: 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. PLEASE DESCRIBE THE LOCATION IN THE BODY FOR THE INTENDED TARGET SITE (PANCREAS, STOMACH, LUNGS, ETC). IF LUNGS, WHICH LYMPH NODE WAS BEING TARGETED? E.G. 2R, 2L, 4R, AO, AR, 11RI, 11S, ETC. LUNGS/LYMPH NODE R PARATRACHEAL. PLEASE DESCRIBE THE SIZE OF THE INTENDED TARGET SITE. UNKNOWN. IF NOT WITH THE DEVICE IN QUESTION, HOW WAS THE PROCEDURE PERFORMED AND/OR FINISHED? THIS WAS THE LAST SITE FOR SPECIMENS, PROCEDURE FINISHED USING BRONCHOSCOPE TO LOOK FOR NEEDLE TIP. WAS THE DEVICE USED IN A TORTUOUS POSITION? UNKNOWN. ARE IMAGES OF THE DEVICE OR PROCEDURE AVAILABLE? YES. WAS THE DEVICE DAMAGED IN PACKAGING BEFORE REMOVAL? NO. WAS THE DEVICE DAMAGED ON REMOVAL FROM PACKAGING? NO. WAS FORCE REQUIRED TO REMOVE THE DEVICE? WHAT IS THE ENDOSCOPE MANUFACTURER AND MODEL NUMBER THAT WAS USED? FORCE: UNKNOWN ; ENDOSCOPE MANUFACTURER AND MODEL INFO: OLYMPUS EVIS EXERA II UC180F OLYMPUS BF, 1800190. WAS THE SCOPE RECENTLY SERVICE/REPAIRED? UNKNOWN. WAS FORCE REQUIRED ON INSERTION OF DEVICE INTO SCOPE? UNKNOWN. WAS RESISTANCE FELT WHILE INSERTING THE DEVICE THROUGH THE SCOPE? UNKNOWN. WHEN WAS THE ISSUE NOTED? E.G. ON ADVANCEMENT OF THE SHEATH/NEEDLE OR ON NEEDLE RETRACTION? ISSUE NOTICED WHEN REMOVING EBUS SCOPE, NEEDLE TIP SEEN IN LUNG BY MD AFTER NEEDLE HAD BEEN REMOVED, CONFIRMED NEEDLE TIP MISSING BY RT AND CYTOLOGY TECH WHEN COLLECTING SPECIMEN. WAS THE SYRINGE USED DURING THE PROCEDURE, AFTER THE STYLET WAS REMOVED? YES. WAS DIFFICULTY EXPERIENCED WHILE RETRACTING THE NEEDLE? UNKNOWN. WAS IT POSSIBLE TO BE FULLY RETRACT BEFORE REMOVING THE NEEDLE FROM THE PATIENT? UNKNOWN, BUT MD DID NOT VOICE ANY CONCERN. WAS GAINING ACCESS TO THE TARGETED SITE DIFFICULT? UNKNOWN. WAS THE ENDOSCOPE IN A FLEXED OR TWISTED POSITION AT ANY TIME DURING THE PROCEDURE? UNKNOWN. WAS PUNCTURE OF THE TARGETED SITE DIFFICULT? UNKNOWN. WAS THE STYLET FULLY IN PLACE INSIDE THE NEEDLE WHEN ADVANCING INTO THE TARGETED SITE? YES. WAS THE STYLET PARTIALLY REMOVED WHEN ADVANCING INTO THE TARGET SITE? NO. HOW MANY SAMPLES WERE OBTAINED WITH THIS NEEDLE? MULTIPLE, EXACT NUMBER UNKNOWN. DID ANY SECTION OF THE DEVICE DETACH INSIDE THE PATIENT? NEEDLE TIP. IF THE DEVICE KINKED BELOW THE SHEATH EXTENDER, WAS THE KINK OBSERVED BEFORE INSERTING THE DEVICE INTO THE SCOPE? UNKNOWN. WAS THERE DIFFICULTY LOCKING THE SHEATH (OR NEEDLE) IN PLACE OR SLIPPING EXPERIENCED DURING USE? UNKNOWN. WAS THERE DIFFICULTY IN ATTACHING OR DETACHING OF THE DEVICE LEUR LOCK TO THE SCOPE? NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1379192 ECHOTIP PROCORE ENDOBRONCHIAL HD BIOPSY NEEDLE FCG KIT, NEEDLE, BIOPSY FCG COOK IRELAND LTD C1755687 10827002342818

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention