MAUDE Adverse Event Report: Argon Medical Devices, Inc BioPince Ultra Full Core Biopsy Instrument 18ga x 20cm; Instrument, Biopsy

Model Number	360-2080-02
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/17/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Liver biopsy to investigate histological changes consistent with immunotherapy-associated hepatitis.Loading/tensioning the biopince was somewhat difficult but feasible (this issue occurs with nearly all biopince biopsy needles).Dry firing/triggering was possible without any problems.Re-tensioning is possible.Sample collection with normal visibility on ultrasound.The punch cylinder should then be ejected.The tensioning required for ejection is very difficult but ultimately possible.During ejection, a small gray piece (presumably from inside the biopince) breaks off and falls onto the sterile table.If the biopince could not have been clamped open, the sample could not have been ejected and analyzed.In that case, a repeat biopsy would have been necessary.This would have carried an increased risk of bleeding, etc., since the first biopsy was performed without an over-needle closure technique, based on the assumption that only a single sample collection was necessary.
Additional Manufacturer Narrative
The sample is indicated as available for return.As of the date of this report, the sample has not been returned.A follow-up report will be provided once the device has been received and reviewed.

• Brand Name: BioPince Ultra Full Core Biopsy Instrument 18ga x 20cm
• Common Device Name: Instrument, Biopsy
• Manufacturer (Section D): Argon Medical Devices, Inc; 1445 flat creek road; athens TX 75751
• Manufacturer Contact: kelly mayer ; 1445 flat creek road; athens, TX 75751 ; +1(903)675-9321
• MDR Report Key: 50893144
• Report Number: 0001625425-2026-01022
• Device Sequence Number: 10712629
• Product Code: KNW
• UDI-Device Identifier: 00886333224043
• UDI-Public: (01)00886333224043(17)200123(10)11655479
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K904987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/24/2026

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: 360-2080-02
• Device Lot Number: 11655479
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2026
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/02/2026
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown