BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHOTIP PROCORE ENDOBRONCHIAL HD BIOPSY NEEDLE

    MDR report key: 18273848 · Received December 6, 2023

    Report

    Report Number
    3001845648-2023-00891
    Event Type
    Injury
    Date Received
    December 6, 2023
    Date of Event
    November 7, 2023
    Report Date
    March 6, 2024
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FCG
    UDI-DI
    10827002342795
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) # K210476 1 UNIT OF LOT C2080171 OF ECHO-HD-22-EBUS-P-C WAS RETURNED OPENED NOT IN ITS ORIGINAL PACKAGING. THE DEVICE RELATED TO THIS OCCURRENCE UNDERWENT A LABORATORY EVALUATION ON (B)(6) 2024. THE LAB AND LAB ATTENDANCE CAN BE VIEWED IN THE ¿RETURNED PRODUCT ¿ NOTES¿ SECTION. THE DISTAL END OF THE NEEDLE WAS OBSERVED TO BE BROKEN APPROX. 4CM FROM THE TIP OF THE SHEATH. A PROXIMAL KINK BELOW THE SHEATH EXTENDER WAS OBSERVED. THROUGH THE INVESTIGATION IT WAS ESTABLISHED THAT THE PROXIMAL NEEDLE KINK BELOW THE SHEATH EXTENDER WHICH WAS OBSERVED DURING THE LAB EVALUATION WAS NOT OBSERVED BY THE CUSTOMER AND MOST LIKELY CAME ABOUT AS A RESULT OF THE TRANSPORT RETURNS PROCESS. MANUFACTURING RECORDS PRIOR TO DISTRIBUTION, ALL ECHO-HD-22-EBUS-P-C DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL INSPECTION TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE MANUFACTURING RECORDS FOR ECHO-HD-22-EBUS-P-C OF LOT NUMBER C2080171 DID NOT REVEAL ANY DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. REVIEW HISTORICAL DATA THE REVIEW OF RELEVANT MANUFACTURING RECORDS CONFIRMS THE FAILURE MODE HAS NOT PREVIOUSLY OCCURRED FOR THIS WORK ORDER. INSTRUCTIONS FOR USE AND/LABEL THE NOTES SECTION OF THE INSTRUCTIONS FOR USE, IFU0110 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 (IFU0110) IMAGE REVIEW AN IMAGE WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE ANALYSIS 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 DIFFICULT TARGET SITE AND ADVANCEMENT INTO A HARD LESION AS PER ADDITIONAL INFORMATION WHICH COULD HAVE CAUSED THE DISTAL END OF THE NEEDLE TO BREAK. ANOTHER POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO DAMAGE ON INSERTION INTO THE SCOPE RESULTING IN THE NEEDLE TIP GETTING DAMAGED AND BREAKING DURING THE PROCEDURE. SUMMARY COMPLAINT IS CONFIRMED BASED ON VISUAL AND/OR FUNCTIONAL INSPECTION. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. THE BROKEN NEEDLE TIP WAS RECOVERED AS IT WAS LOCATED INSIDE THE SHEATH OF THE DEVICE. AN X-RAY, CT OF THE NECK, AND CT OF THE CHEST WERE COMPLETED TO CONFIRM NO NEEDLE FRAGMENTS REMAINED INSIDE THE PATIENT. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR SIMILAR EVENTS.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO COMPLETION OF THE INVESTIGATION ON (B)(6)-2024

    Description of Event or Problem · 0

    AS INITIALLY REPORTED TO CUSTOMER RELATIONS: THE TIP OF A NEEDLE BROKE OFF DURING A EBUS PROCEDURE. THE TIP OF THE NEEDLE WAS RECOVERED. 4.1 FOR ALL COMPLAINTS, ASK: ¿ ARE IMAGES OF THE DEVICE OR PROCEDURE AVAILABLE? YES, I HAVE PICTURES OF THE DEVICE, NO IMAGES FROM THE PROCEDURE ¿ 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 ¿ WERE ANY OTHER DEFECTS (OTHER THAN THE COMPLAINT ISSUE) OBSERVED ON THE DEVICE PRIOR TO RETURN (E.G. KINK)? PHYSICIAN REPORTED THE NEEDLE BENDING WHEN ATTEMPTING A BIOPSY O 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, ¿ IF THE DEVICE IS A PROCORE NEEDLE, IS THE DEVICE DAMAGE LOCATED AT THE NOTCH / CORE TRAP? UNSURE O IF NO, PLEASE SPECIFY WHERE THE DAMAGE IS LOCATED: ¿ WAS GAINING ACCESS TO THE TARGET SITE DIFFICULT? YES ¿ WAS THE DEVICE USED IN A TORTUOUS POSITION? NO ¿ WAS PUNCTURE OF THE TARGET SITE DIFFICULT? YES ¿ PLEASE DESCRIBE THE ANATOMICAL LOCATION OF THE INTENDED TARGET SITE (PANCREAS, STOMACH, LUNGS ETC.). IF THE LUNGS, WHICH LYMPH NODE WAS BEING TARGETED? 4L ¿ 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? OPENED AN ADDITIONAL NEEDLE ¿ WAS THE DEVICE DAMAGED IN PACKAGING PRIOR TO REMOVAL? NO ¿ WAS THE DEVICE DAMAGED ON REMOVAL FROM PACKAGING? NO ¿ WAS FORCE REQUIRED TO REMOVE THE DEVICE? NO ¿ DID THE PATIENT REQUIRE ANY ADDITIONAL PROCEDURES AS A RESULT OF THIS EVENT? YES ¿ WHAT INTERVENTION (IF ANY) WAS REQUIRED? REPEAT BRONCHOSCOPY, CHEST XRAY, AND MULTIPLE CT SCANS ¿ WAS THE SECONDARY INTERVENTION PERFORMED DURING THE SAME PROCEDURE AS THE DEVICE FAILURE OR WAS IT SCHEDULED FOR ANOTHER DAY? SAME PROCEDURE ¿ WERE ANY OTHER DEFECTS OBSERVED ON THE DEVICE PRIOR TO RETURN (E.G. KINKS, BENDS, BREAKS ETC.)? NO O 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? PENTAX EB19-J10U ¿ WAS RESISTANCE FELT WHILE INSERTING THE DEVICE THROUGH THE SCOPE? NO ¿ WAS THE SCOPE RECENTLY SERVICED / REPAIRED? NO ¿ WHEN WAS THE ISSUED WITH THE PRODUCT NOTED? ON ADVANCEMENT OF THE SHEATH/NEEDLE OR ON NEEDLE RETRACTION? ON ADVANCEMENT OF THE NEEDLE ¿ WAS THE SYRINGE USED DURING THE PROCEDURE, AFTER THE STYLET WAS REMOVED? NO, DUE TO THE DAMAGED NEEDLE ¿ WAS DIFFICULTY EXPERIENCED WHILE RETRACTING THE NEEDLE? NO ¿ WAS IT POSSIBLE TO FULLY RETRACT THE NEEDLE INTO THE SHEATH BEFORE REMOVING THE DEVICE FROM THE PATIENT? N/A, WAS NOT ATTEMPTED ¿ WAS THE ENDOSCOPE IN A FLEXED OR TWISTED POSITION AT ANY TIME DURING THE PROCEDURE? UNKNOWN ¿ WAS THE STYLET PARTIALLY REMOVED WHEN ADVANCING THE NEEDLE INTO THE TARGET SITE? UNKNOWN ¿ HOW MANY SAMPLES WERE OBTAINED (PASSES COMPLETED) WITH THIS NEEDLE? UNKNOWN ¿ DID ANY SECTION OF THE DEVICE DETACH INSIDE THE PATIENT? NO O IF YES, PLEASE SPECIFY: ¿ WAS THERE DIFFICULTY LOCKING THE SHEATH (OR NEEDLE) IN PLACE OR SLIPPING EXPERIENCED DURING USE? NO ¿ WAS THERE DIFFICULTY IN ATTACHING OR DETACHING THE DEVICE TO THE ACCESSORY CHANNEL PORT ON THE SCOPE? 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? UNKNOWN ¿ IF AN EBUS PROCEDURE DID THE NEEDLE TIP HIT THE CARTILAGE RINGS OF THE TRACHEA? NO ADDITIONAL QUESTIONS REQUESTED 27NOV2023 SENT TO CUSTOMER. REPLY AND IMAGES RECEIVED 29NOV2023. (IMAGES ARE ATTACHED TO EMAIL LABELED- 01DEC2023_PR413776_CMLLC_REPLY TO PT OUTCOME, ADD'L QUESTIONS_ TH 27NOV2023.MSG) TH 01DEC2023 IT IS STATED THAT THE BROKEN NEEDLE TIP WAS RECOVERED O WOULD YOU BE ABLE TO CONFIRM HOW THE TIP WAS RECOVERED E.G. BY FORCEPS, LOOP CATHETER, OTHER MEANS THE BROKEN TIP WAS LOCATED INSIDE THE SHEATH OF THE NEEDLE. DID ANY UNINTENDED SECTION OF THE DEVICE REMAIN INSIDE THE PATIENT¿S BODY? NO PARTS OR PIECES OF THE DEVICE REMAINED IN THE PATIENT. WAS THE PATIENT HOSPITALIZED OR WAS THERE PROLONGED HOSPITALIZATION? ONCE WE CONFIRMED NO NEEDLE FRAGMENTS REMAINED IN PATIENT. THE PATIENT WAS ABLE TO BE DISCHARGED THE SAME DAY. DID THE PATIENT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE? O IF YES, PLEASE DESCRIBE. AN X-RAY, CT OF THE NECK, AND CT OF THE CHEST WERE COMPLETED TO CONFIRM NO NEEDLE FRAGMENTS REMAINED. DID THE PRODUCT CAUSE OR CONTRIBUTE TO THE NEED FOR ADDITIONAL PROCEDURES? O IF YES, PLEASE SPECIFY ADDITIONAL PROCEDURES AND PROVIDE DETAILS. YES, THE SCANS WERE ORDERED TO CONFIRM NO METAL FRAGMENTS REMAINED INSIDE OF THE PATIENT 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? O PLEASE SPECIFY ADVERSE EFFECTS AND PROVIDE DETAILS. NO

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    73298 ECHOTIP PROCORE ENDOBRONCHIAL HD BIOPSY NEEDLE FCG KIT, NEEDLE, BIOPSY FCG COOK IRELAND LTD C2080171 10827002342795

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention