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

Model Number	G34281
Medical Device Problem Codes	Retraction Problem (1536); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
Event or Problem Description
As reported on ahs mdip report: "patient was having an ebus procedure done.When removing the sample from the needle i was unable to pull the needle back into the sheath.Physician made aware.New needle opened to finish the procedure.".
Additional Manufacturer Narrative
Device evaluation: the device evaluation could not be completed as the device or photographic evidence of lot c2276451 of echo-hd-22-ebus-o-c device was not returned for evaluation.It had been indicated that the complaint device was going to be returned but to date it has not been returned.Three attempts were also made to request answers for additional information.To date no reply has been received.If a reply is received in the future, then the file will be updated accordingly.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 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, 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 (ifu0109).Image review: an image was not returned for evaluation.Root cause analysis: a definitive root cause could not be determined from the available information.The root cause is unknown as no device has been returned to confirm a material issue, but a possible root cause could be attributed to damage on insertion into the scope resulting in the needle to kink or bend which in turn could have led to the complaint issue the user encountered of being unable to retract the needle into the sheath.The customer has stated in the answers to the additional information that there was no kink on the proximal or distal end of the needle observed but a slight distal kink may have occurred after the initial successful passes when the needle was outside the scope or prior to the third pass.The issue could also be related to the device being held at an angle during retraction, potentially due to a tortuous anatomy, which may have impeded smooth needle movement.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.
Event or Problem Description
A supplemental report is being submitted due to completion of the investigation on 06-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 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: 23069916
• Report Number: 3001845648-2025-00470
• Device Sequence Number: 17304495
• Product Code: FCG
• UDI-Device Identifier: 00827002342811
• UDI-Public: (01)00827002342811(17)280312(10)C2276451
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 11/06/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: G34281
• Device Catalogue Number: ECHO-HD-22-EBUS-O-C
• Device Lot Number: C2276451
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/02/2025
• Event Location: Hospital
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/28/2025
• Supplement Date Received by Manufacturer: 08/28/2025
• Initial Report FDA Received Date: 09/16/2025
• Supplement Report FDA Received Date: 11/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/12/2025
• 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
• Patient Sex: Unknown