MAUDE Adverse Event Report: ARGON MEDICAL DEVICES BIOPINCEULTRA FULL CORE BIOPSY INSTRUMENT 16GA X 15CM; INSTRUMENT, BIOPSY

Model Number	370-1580-02
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sample was returned to argon for investigation.The investigation is currently in progress.A final report will be submitted upon investigation completion.
Event or Problem Description
A customer reported "one of our 16ga core biopsy guns broke when dr was using it.We fired it a couple times with no issues and then after the 3rd fire when she pulled it out the tip of the instrument was busted open." sample and image available.
Additional Manufacturer Narrative
A review of the manufacturing and inspection records for this lot was conducted.No deviations or non-conformances were found.One opened sample was returned from the customer for review.A visual inspection was performed on the returned products, and it was found that the tri-tips were bent out of shape, preventing the device from properly obtaining a sample, hence the complaint was confirmed.There are stringent computer and photographic inspections that ensure the cannula tri-tips are not deformed during the manufacturing process.The tri-tip damage was likely caused by the device striking a hard external surface or a hard object such as a bone or possibly getting caught on some human tissue and pulling back.Since the most likely cause for the damaged needles is related to an event within the user's environment and not a manufacturing issue, no corrective action can be implemented at this time.Additional information provided in h.3, h.6.And h.11.

• Brand Name: BIOPINCEULTRA FULL CORE BIOPSY INSTRUMENT 16GA 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: 23478904
• Report Number: 0001625425-2025-01122
• Device Sequence Number: 18701507
• Product Code: KNW
• UDI-Device Identifier: 00886333224081
• UDI-Public: (01)00886333224081(17)270926(10)11592129
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2026

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: 370-1580-02
• Device Lot Number: 11592129
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2025
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/06/2025
• Supplement Date Received by Manufacturer: 03/09/2026
• Initial Report FDA Received Date: 11/05/2025
• Supplement Report FDA Received Date: 03/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/27/2024
• 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