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

Model Number	G34281
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A complete initial report is being submitted due to completion of investigation on 21 nov 2025.The needle did not able to advance out from the sheath.Ebus pro ptb for hepatitis b 1.Can it be clarified what is mean by ebus pro ptb procedure? ans.Ebus tbna.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.) ans.Lung, node 7.3.Was puncture of the targeted site difficult? ans.Yes, needle couldn't puncture, dr tried around 6-7 times.Previously has no problem with our needle, now he's worried to just simply use our needle, worrying the same thing would happen again.4.What is the scope manufacturer and model number that was used? ans.Olympus, bf-th1100, bf-uc180f.5.Was the scope recently service/repaired? ans.Maintained as usual.6.Was the device used in a tortuous position? ans.No.7.Was the device damaged in packaging before removal? n/a, yes, no.Ans.No.8.Was the device damaged on removal from packaging? n/a, yes, no.Ans.No.9.Was force required to remove the device? n/a, yes, no.Ans.No.10.When was the issue noted? e.G., on advancement of the sheath/needle or on needle retraction? ans.Needle couldn't puncture the site.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).Ans.No.12.If not with the device in question, how was the procedure performed and/or finished? ans.Using olympus needle.13.If the report involves a kink, bend, or break 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.Ans.N/a.14.Was gaining access to the target site difficult? ans.No.15.Was force required on insertion of device into scope? ans.No.16.Was resistance felt while inserting the device through the scope? n/a, yes, no.Ans.No.17.Was there difficulty locking the sheath (or needle) in place or slipping experienced during use? ans.Somehow yes, slightly loose & rotatable, while using olympus & fuji scope (dr).18.If the device was kinked below the sheath extender, was the kink observed before inserting the device into the scope? n/a, yes, no.Ans.No.19.Was the endoscope in a flexed or twisted position at any time during the procedure? ans.No.20.Was the stylet partially removed when advancing the needle into the target site? ans.No, it's fully advanced.21.Was the syringe used during the procedure, after the stylet was removed? ans.Never even able to puncture.22.Was difficulty experienced while retracting the needle? ans.No, needle just didn't puncture.23.Was it possible to be fully retract before removing the needle from the patient? ans.Yes.No issue in advancing and retracting needle.24.How many samples were obtained (passes completed) with this needle? ans.The needle unable to puncture.No sample taken using the 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? ans.No.The scope was in neutral position.26.If an ebus procedure, did the needle tip hit the cartilage rings of the trachea? ans.No.Additional questions.Q1) the answer to q17 is the 1st mention that a fuji scope was used , 4 it is said that a olympus was used (olympus, bf-th1100, bf-uc180f).Were there 2 scopes used in the procedure? ans.Only olympus was used during the case (olympus, bf-th1100, bf-uc180f) q2) was there any difficulty locking the sheath in place or the needle in place? ans.No difficulty in locking the shealth/ needle handle in place.However, sometimes the adaptor is slightly loose & rotatable during procedure.
Additional Manufacturer Narrative
Device evaluation: the device evaluation for the echo-hd-22-ebus-o-c device of lot c2307812 was returned for evaluation open not 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 on 14th oct 2025 the following was observed in the lab: visual inspection: distal end of needle examined, and no issue observed.Stylet examined, and no issue observed.Adapter examined and no issues 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.Needle removed from device and slight kink below sheath extender observed.The reported failure was not observed.Manufacturing records: prior to distribution all devices are subjected to a visual inspection and functional inspection to ensure device integrity.A review of the manufacturing records of lot number c2307812 did not reveal any discrepancies that could have contributed to this complaint issue.Review historical data: the review of relevant manufacturing records of lot number c2307812 confirms the failure mode did previously occurred for this work order.The failure mode was attributed to damage at the patient end of the needle during insertion or advancement through the scope after the first pass, which could have led to the distal needle kink.Instructions for use and/label the instructions for use, ifu0109 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.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 the circumstances of use could not be replicated in the laboratory.A possible root cause may be attributed to damage during handling, setup or advancement down the scope resulting in the needle kinking below the sheath extender which contributed to the inability to advance the needle out the sheath.A capa (pr 217973) has been initiated to document and track the actions taken to investigate and to address kinking or breaking of the sheath at the sheath/sheath extender junction.All lots manufactured from the 10th/11th may 2022 have the capa improvements.A review took place to check the manufacture date of the lot related to this complaint and it was confirmed that it was manufactured after the corrective action being implemented.However, this kink is considered outside the scope of the capa.Confirmation of complaint complaint is confirmed based on customer and/or rep testimony corrective action/ correction complaints of this nature will continue to be monitored for similar events summary of investigation the needle of the echo-hd-22-ebus-o-c device of lot c2307812 was unable to be advance from the sheath.Confirmed quantity of 1 device, confirmed used.According to the initial report, the patient did not experience any adverse effects due to this occurrence.The procedure was completed with another needle.

• 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 00000 ; IE 00000
• 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: 23724189
• Report Number: 3001845648-2025-00623
• Device Sequence Number: 10596131
• Product Code: FCG
• UDI-Device Identifier: 00827002342811
• UDI-Public: (01)00827002342811(17)280610(10)C2307812
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• 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
• Report Date (Section B): 11/21/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: G34281
• Device Catalogue Number: ECHO-HD-22-EBUS-O-C
• Device Lot Number: C2307812
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2025
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/18/2025
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2025
• Initial Report FDA Received Date: 12/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/10/2025
• 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
• Patient Sex: Unknown