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

Model Number	360-1580-02
Medical Device Problem Code	Misfire (2532)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sample was returned to argon for investigation.The investigation is currently in progress.A follow-up report will be submitted upon investigation completion.
Event or Problem Description
A lead ct tech reported the device discharged without being fired.
Additional Manufacturer Narrative
We¿ve completed a review of the manufacturing and inspection records for this lot and found everything to be within specification, with no deviations or non-conformances noted.We also received two samples back for evaluation.After performing a visual inspection, we did not observe any signs of damage.Each device was test fired five times and operated as intended.Upon disassembly of the returned devices, excess adhesive was observed on the front trigger arms.This condition may contribute to increased resistance when operating the front trigger.Based on this evaluation, the complaint has been confirmed.An internal investigation has been initiated to identify the root cause and implement appropriate corrective actions.Additional information provided in h.3., h.6.And h.11.

• Brand Name: BIOPINCE ULTRA FULL CORE BIOPSY INSTRUMENT 18GA X 15CM)
• Common Device Name: INSTRUMENT, BIOPSY
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek road; athens TX 75751
• Manufacturer Contact: kelly mayer ; 1445 flat creek road; athens, TX 75751 ; 9036759321
• MDR Report Key: 21741246
• Report Number: 0001625425-2025-00980
• Device Sequence Number: 18392791
• Product Code: KNW
• UDI-Device Identifier: 00886333224029
• UDI-Public: (01)00886333224029(17)270919(10)11591189
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2025

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: 360-1580-02
• Device Lot Number: 11591189
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2025
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2025
• Supplement Date Received by Manufacturer: 07/03/2025
• Initial Report FDA Received Date: 04/01/2025
• Supplement Report FDA Received Date: 07/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/20/2024
• 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