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

Model Number	G34279
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Endobronchial ultrasound needle used for needle biopsy during bronch procedure; needle broke off in the patients bronchial.Dr.(b)(6) to use biopsy forceps to retrieve broken needle piece out of bronchial.

• Brand Name: ECHOTIP PROCORE
• Common Device Name: BIOPSY NEEDLE
• Manufacturer (Section D): COOK IRELAND LTD; 750 daniels way; bloomington IN 47404
• MDR Report Key: 24638360
• Report Number: 24638360
• Device Sequence Number: 13313966
• Product Code: FCG
• UDI-Device Identifier: 00827002342798
• UDI-Public: (01)00827002342798
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/24/2026
• Report Date (Section F): 02/24/2026

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: G34279
• Device Catalogue Number: ECHO-HD-22-EBUS-P-C
• Device Lot Number: C2358421
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2026
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/19/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/19/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 80 YR
• Patient Sex: Female
• Date Report Sent to FDA: 02/24/2026