MAUDE Adverse Event Report: COOK IRELAND LTD ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE; FCG BIOPSY NEEDLE

Model Number	G34785
Medical Device Problem Codes	Break (1069); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/04/2025
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
Fnb procedure was being performed with echo-hd-3-20-c.3rd puncture was successful.But at the 4th puncture, the assistant nurse found that the needle tip bent.She was worried about the needle broken.So, the physician withdrew the needle out of the scope and session repeated with another new needle.(replaced another procore).
Additional Manufacturer Narrative
Supplemental report is being submitted as a cancellation report following the completion of the lab evaluation on 08-oct-2025 as the complaint no longer meets the description of a reportable incident (needle kinks distally).Fda mdr reporting not required: the event does not meet the criteria of an fda ¿serious injury¿ report or ¿malfunction¿ report as per fda guidelines ¿medical device reporting for manufacturers (2016)¿.No reporting malfunction precedence exists for this complaint event for this product family.No risk of failure mode indicates no potential for serious injury if the malfunction were to recur.No adverse effect to the patient was reported as occurring.
Event or Problem Description
Supplemental report is being submitted as a cancellation report following the completion of the lab evaluation on 08-oct-2025 as the complaint no longer meets the description of a reportable incident (needle kinks distally).Fda mdr reporting not required: the event does not meet the criteria of an fda ¿serious injury¿ report or ¿malfunction¿ report as per fda guidelines ¿medical device reporting for manufacturers (2016)¿.No reporting malfunction precedence exists for this complaint event for this product family.No risk of failure mode indicates no potential for serious injury if the malfunction were to recur.No adverse effect to the patient was reported as occurring.

• Brand Name: ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND 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: 23110221
• Report Number: 3001845648-2025-00482
• Device Sequence Number: 13282304
• Product Code: FCG
• UDI-Device Identifier: 00827002347854
• UDI-Public: (01)00827002347854(17)280327(10)C2282112
• Combination Product (Y/N): N
• Initial Reporter Country: KR
• 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): 10/08/2025

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: G34785
• Device Catalogue Number: ECHO-HD-3-20-C
• Device Lot Number: C2282112
• 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: 09/04/2025
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2025
• Supplement Date Received by Manufacturer: 09/04/2025
• Initial Report FDA Received Date: 09/22/2025
• Supplement Report FDA Received Date: 10/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/27/2025
• 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