MAUDE Adverse Event Report: ARGON MEDICAL DEVICES BIOPINCE FULL CORE BIOPSY INSTRUMENT 18G X 15CM; INSTRUMENT, BIOPSY

Model Number	360-1580-01
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Pneumothorax (2012)
Date of Event	11/08/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2025, the department of nephrology of (b)(6).Used a disposable biopsy needle to perform a liver puncture on a patient.The needle tip broke, causing serious surgical difficulties for the operation supervisor.Please handle it as soon as possible.This patient is a liver cancer patient and the goods cannot be mailed.
Additional Manufacturer Narrative
The sample is not available for return.The investigation is currently in progress.A follow-up report will be submitted upon investigation completion.
Additional Manufacturer Narrative
We conducted a thorough review of the manufacturing and inspection records for this lot and found no deviations or non-conformances.Unfortunately, we did not receive any samples for evaluation, nor did we receive any photographic or visual evidence that would have allowed us to review the allegation in detail.Without this necessary evidence, we are unable to perform a thorough investigation or determine a root cause and corrective action at this time.As a result, no corrective action is required at this point.However, if samples are returned at a later date, we would be happy to reopen this complaint for re-evaluation.Additional information provided in h.6.And h.11.

• Brand Name: BIOPINCE FULL CORE BIOPSY INSTRUMENT 18G X 15CM
• Common Device Name: INSTRUMENT, BIOPSY
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek road; athens TX 75758
• Manufacturer Contact: kelly mayer ; 1445 flat creek road; athens, TX 75758 ; 9036759321
• MDR Report Key: 23860038
• Report Number: 0001625425-2025-01160
• Device Sequence Number: 4989994
• Product Code: KNW
• UDI-Device Identifier: 00886333004355
• UDI-Public: (01)00886333004355(17)270718(10)11581295
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K904987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2026

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: 360-1580-01
• Device Lot Number: 11581295
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2025
• Supplement Date Received by Manufacturer: 04/08/2026
• Initial Report FDA Received Date: 12/20/2025
• Supplement Report FDA Received Date: 04/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/14/2025
• 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
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian