MAUDE Adverse Event Report: COOK IRELAND LTD ECHOTIP PROCORE ENDOBRONCHIAL HD BIOPSY NEEDLE; FCG BIOPSY NEEDLE

Model Number	G34279
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Foreign Body In Patient (2687)
Date of Event	09/12/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
Event or Problem Description
During a procedure, while performing a puncture of a lymph node in region 4l (fourth puncture), we were unable to see the needle inside the lymph node, although the rest of the technique went smoothly.After a superficial examination, we found no abnormalities, but despite washing the working channel and cleaning the ultrasound probe, we still could not see the needle inside the lymph node on the ultrasound image.We then decided to open a second needle, with which we were able to continue the examination "as per cc form": during a procedure, while performing a puncture of a lymph node in region 4l (fourth puncture), we were unable to visualize the needle inside the node, although the rest of the technique presented no difficulties.After a superficial inspection, we did not notice any abnormalities, but despite flushing the working channel and cleaning the ultrasound probe, the needle still could not be seen within the lymph node on the ultrasound image.At that point, we decided to open a second needle, which allowed us to continue the procedure.However, as we proceeded, we noticed an image within the bronchoscope that we identified as part of the needle.It turned out that the needle had broken, and the distal part had remained lodged in the mucosa of the tracheal wall.Once the ebus procedure was completed, we immediately performed a standard bronchoscopy, during which we confirmed the needle fracture and observed a laceration of the bronchial wall caused by the broken fragment.This was complicated by active bleeding, which we were able to control.The needle fragment was successfully removed from the bronchial tree, and the patient is currently in stable condition.Device remain inside patient = the part of the broken needle detailed description of the medical or surgical interventions = thoracoscopy to remove the needle and stop the bleeding.1.Will the product be returned? waiting for answer 2.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.): while performing a puncture of a lymph node in region 4l (fourth puncture) 3.Was gaining access to the target site difficult? no 4.Was puncture of the targeted site difficult? no 5.What is the scope manufacturer and model number that was used? pentax i don't know the model number 6.Was the scope recently service/repaired? no 7.Was the device used in a tortuous position? a little 4l 8.Was the device damaged in packaging before removal? no 9.Was the device damaged on removal from packaging? no 10.Was force required to remove the device? no 11.Were any other defects (other than the complaint issue) observed on the delivery system (e.G., kinks) prior to return? (if yes, please specify what additional defect(s) were observed and where on the device this was observed) n/a 12.Did the patient require any additional procedures as a result of this event? yes ;removal of the piece of needle 13.If additional intervention was performed, was it during the same procedure as the device failure or was it scheduled for another day? same day 14.Was force required on insertion of device into scope? no 15.Was resistance felt while inserting the device through the scope? no 16.If the device was kinked below the sheath extender, was the kink observed before inserting the device into the scope? n/a 17.When was the issued with the product noted? at that point, we decided to open a second needle, which allowed us to continue the procedure.However, as we proceeded, we noticed an image within the bronchoscope that we identified as part of the needle.It turned out that the needle had broken, and the distal part had remained lodged in the mucosa of the tracheal wall.18.Was the endoscope in a flexed or twisted position at any time during the procedure? flexed 19.Was the stylet partially removed when advancing the needle into the target site? we don't know 20.Was the syringe used during the procedure, after the stylet was removed? yes 21.Was difficulty experienced while retracting the needle? no 22.Was it possible to be fully retract before removing the needle from the patient? yes 23.How many samples were obtained (passes completed) with this needle? 4 24.Did any section of the device detach inside the patient? yes 3 cm of needle 25.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 26.For procore needle, is the device damage located at the notch/core trap? yes (if no, please specify where the damage is located) it turned out that the needle had broken, and the distal part had remained lodged in the mucosa of the tracheal wall.27.If an ebus procedure, did the needle tip hit the cartilage rings of the trachea? yes.
Additional Manufacturer Narrative
Device evaluation: 1 unit of lot number c2308364 of echo-hd-22-ebus-p-c was returned open in its original packaging for evaluation.With the information provided, a physical examination investigation was conducted.The device related to this occurrence underwent a laboratory evaluation on the 30th of october 2025.On evaluation of the devices the following observations were made: visual inspection: distal end of needle returned separate to the device.Broken distal end measured to be 1.5cm from tip of the needle.Stylet examined and no issue observed.Functional inspection: sheath extender able to advance and retract without issue.Needle handle able to advance and retract without issue.Stylet removed from device without issue.Stylet re-inserted into device without issue.The reported failure was observed.Photographic evidence was returned for evaluation.The review of the photos determined the following: image 1 displays the reported issue, showing the recovered broken part of the needle.Image 2 shows the broken tip of the needle alongside a new device for comparison, and image 3 features an image of the product label.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.Based on the information available to date, there is no evidence to suggest that there are any manufacturing issues associated with lot number c2308364.A review of the manufacturing records for echo-hd-22-ebus-p-c of lot number c2308364 did not reveal any discrepancies that could have contributed to this complaint issue.Historical data review: the review of relevant manufacturing records confirms the failure mode has not previously occurred for this work order.Instructions for use and/label: the warnings 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 could not be determined.A potential root cause could be attributed to the endoscope being in a flexed position during the procedure, as indicated in the additional information, which could have caused the breakage of the needle's distal end.Additionally, the needle likely fractured due to mechanical stress from slight tortuosity in the device's position while performing a fourth puncture on a lymph node in region 4l.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 similar events.Summary of investigation: according to the customer, ¿during a procedure, we were unable to see the needle inside the lymph node.At that point, we decided to open a second needle, which allowed us to continue the procedure.However, as we proceeded, we noticed an image within the bronchoscope that we identified as part of the needle.It turned out that the needle had broken, and the distal part had remained lodged in the mucosa of the tracheal wall.¿ confirmed quantity of 1 device, confirmed used.According to the initial reporter, the distal end of needle broke inside the patient¿s body.Patient experienced a laceration of the bronchial wall caused by the broken fragment.This was complicated by active bleeding, which doctors were able to control.The needle fragment was successfully removed from the bronchial tree, and the patient is currently in stable condition.A thoracoscopy was used to remove the broken part of the needle and stop the bleeding.Investigation findings conclude that a definitive root cause could not be determined.A potential root cause could be attributed to the endoscope being in a flexed position during the procedure, as indicated in the additional information, which could have caused the breakage of the needle's distal end.Additionally, the needle likely fractured due to mechanical stress from slight tortuosity in the device's position while performing a fourth puncture on a lymph node in region 4l.Complaints of this nature will continue to be monitored for similar events.Complaint is confirmed based on visual and/or functional inspection.
Event or Problem Description
Supplemental report is being submitted due to the completion of the investigation on 18-nov-2025.

• Brand Name: ECHOTIP PROCORE ENDOBRONCHIAL HD BIOPSY NEEDLE
• Common Device Name: FCG BIOPSY NEEDLE
• Manufacturer (Section D): COOK IRELAND LTD; o'halloran rd; national technology park; limerick
• Manufacturer (Section G): COOK IRELAND LTD; o'halloran rd; national technology park; limerick 00000 ; IE 00000
• Manufacturer Contact: sinead o'leary ; o'halloran rd; national technology park; limerick 00000 ; IE 00000 ; 061334440
• MDR Report Key: 23151815
• Report Number: 3001845648-2025-00492
• Device Sequence Number: 20128266
• Product Code: FCG
• UDI-Device Identifier: 00827002342798
• UDI-Public: (01)00827002342798(17)280611(10)C2308364
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K210476
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: G34279
• Device Catalogue Number: ECHO-HD-22-EBUS-P-C
• Device Lot Number: C2308364
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/12/2025
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2025
• Supplement Date Received by Manufacturer: 09/12/2025
• Initial Report FDA Received Date: 09/25/2025
• Supplement Report FDA Received Date: 12/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/11/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown