MAUDE Adverse Event Report: ARGON MEDICAL DEVICES BIOPINCE ULTRA FULL CORE BIOPSY INSTRUMENT WITH CO-AXIAL INTRODUCER NEEDLE; INSTRUMENT, BIOPSY

Model Number	360-1080-03
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/04/2024
Type of Reportable Event	Malfunction
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.
Event or Problem Description
Biopsy was performed on patient.As sample was removed, the metal outer cannula tip of the device was embedded in the sample, the needle pincer was fully exposed.There was no patient harm.
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 pincer was bent back and the tri-tips were broken off the tip of the cannula, preventing the device from properly obtaining a sample, hence the complaint is 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 not related to a manufacturing issue, no corrective action can be implemented at this time.

• Brand Name: BIOPINCE ULTRA FULL CORE BIOPSY INSTRUMENT WITH CO-AXIAL INTRODUCER NEEDLE
• 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: 21392416
• Report Number: 0001625425-2025-00945
• Device Sequence Number: 18239746
• Product Code: KNW
• UDI-Device Identifier: 00886333224005
• UDI-Public: (01)00886333224005(17)270228(10)11561544
• 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: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/30/2025

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: 360-1080-03
• Device Lot Number: 11561544
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2025
• Supplement Date Received by Manufacturer: 05/01/2025
• Initial Report FDA Received Date: 02/18/2025
• Supplement Report FDA Received Date: 05/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/29/2024
• 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