MAUDE Adverse Event Report: ARGON MEDICAL DEVICES BIOPINCE FULL CORE BIOPSY INSTRUMENT 18G X 20CM; INSTRUMENT, BIOPSY

Model Number	360-2080-01
Medical Device Problem Code	Failure to Obtain Sample (2533)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Event or Problem Description
Reporter stated "during a liver biopsy, no tissue can be obtained despite the regular procedure (2 x punctio sicca with the same biopince).Change of biopince, renewed punctio sicca.With the same error.Lot and ref number checked, it was the same batch.Then changed to another batch and it worked without any problems.The patient had to be pricked 4 times, which means an unnecessary and increased risk of bleeding.".
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.
Additional Manufacturer Narrative
A review of the manufacturing and inspection records for this lot was conducted, and no deviations or non-conformances were identified.Two previously opened samples were returned for evaluation, and upon visual inspection, we observed that the pincers were flattened, preventing them from properly obtaining a sample.Based on our assessment, we can confirm the reported issue.Our manufacturing process includes rigorous computer and photographic inspections to ensure the pincer meets quality standards.During operation, the pincer extends from its window and interacts with surrounding tissues and structures.In some cases, the needle set may encounter firmer tissue than anticipated, which could impact the pincer¿s shape.Based on our assessment, the most likely cause of the needle damage does not appear to be related to a manufacturing issue.However, argon is actively working to optimize the assembly process to help mitigate this concern.Additional information provided in d9, h3, h5 and h11.

• Brand Name: BIOPINCE FULL CORE BIOPSY INSTRUMENT 18G X 20CM
• 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: 22180044
• Report Number: 0001625425-2025-01027
• Device Sequence Number: 9274986
• Product Code: KNW
• UDI-Device Identifier: 00886333004348
• UDI-Public: (01)00886333004348(17)270726(10)11582578
• 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,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 360-2080-01
• Device Lot Number: 11582578
• 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: 05/12/2025
• Supplement Date Received by Manufacturer: 07/03/2025
• Initial Report FDA Received Date: 06/10/2025
• Supplement Report FDA Received Date: 07/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/26/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown