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

Model Number	360-1580-01
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	Pain (1994)
Date of Event	05/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A customer reported that during a lung biopsy procedure, after puncture, it was found that the needle tip was damaged, and the patient felt strong pain.There was no patient harm.
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
We conducted a review of the manufacturing and inspection records for this lot and found no deviations or non-conformances.A sample that had been previously opened was returned to us for evaluation.Upon visual inspection, we observed that the pincer had broken flattened and the tri-tips were bent, preventing it from functioning as intended.Based on our review, we can confirm the reported issue.Our manufacturing process includes rigorous computer and photographic inspections to ensure the pincer and tri-tips meet 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 tissue that is firmer than expected, which could affect the pincer¿s positioning.Additionally, tri-tip damage may result from contact with a hard surface or object, such as bone, or from interaction with tissue that causes unexpected resistance.Based on our assessment, the most likely cause of the needle damage does not appear to be related to a manufacturing issue.As a result, no corrective action is necessary at this time.Additional information provided in d.9., h.3., h.6.And h.11.

• Brand Name: BIOPINCE FULL CORE BIOPSY INSTRUMENT 18G 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: 22307765
• Report Number: 0001625425-2025-01045
• Device Sequence Number: 20814420
• Product Code: KNW
• UDI-Device Identifier: 00886333004355
• UDI-Public: (01)00886333004355(17)261110(10)11505845
• 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,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/03/2025

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: 360-1580-01
• Device Lot Number: 11505845
• 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: 05/26/2025
• Supplement Date Received by Manufacturer: 08/12/2025
• Initial Report FDA Received Date: 06/23/2025
• Supplement Report FDA Received Date: 09/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/11/2023
• 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: Other
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 61 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian