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

Model Number	360-2080-01
Medical Device Problem Code	Failure to Obtain Sample (2533)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2024
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
Two dry punctures despite correct handling.Then change to another needle and remove a biopsy cylinder without complications.This has happened several times now.A second or third puncture can lead to bleeding, pain or even a pneumothorax.This is because parenchymal biopsy is performed without a needle.In the worst case, a second biopsy may be necessary if not enough material is obtained.
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 product, and it was found that the pincer was flattened, inhibiting it from properly obtaining a sample.The complaint was confirmed.There are stringent computer and photographic inspections that ensure the pincer is not deformed during the manufacturing process.When the device is cocked, the pincer comes out of its window and becomes exposed to the tissues and structures present during the operation.It is also possible that the needle set was inserted into tissue that was too hard for the sensitive pincer, pushing it flat.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.Additional information provided in d.9., h.3., h.6.And h.11.

• Brand Name: BIOPINCE FULL CORE BIOPSY INSTRUMENT 18G X 20CM
• Common Device Name: BIOPINCE
• 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: 20821099
• Report Number: 0001625425-2024-01160
• Device Sequence Number: 18322174
• Product Code: KNW
• UDI-Device Identifier: 00886333004348
• UDI-Public: (01)00886333004348(17)270127(10)11553789
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2025

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: 360-2080-01
• Device Lot Number: 11553789
• 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: 11/19/2024
• Supplement Date Received by Manufacturer: 12/20/2024
• Initial Report FDA Received Date: 12/02/2024
• Supplement Report FDA Received Date: 01/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/22/2024
• 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 Age: 61 YR
• Patient Sex: Female