MAUDE Adverse Event Report: ARGON MEDICAL DEVICES BIOPINCE ULTRA FULL CORE BIOPSY INSTRUMENT 18GA X 10CM

Model Number	360-1080-02
Medical Device Problem Codes	Break (1069); Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Reporter indicated "fragment broke off into specimen pot when inserting following sample insertion into specimen pot.".
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.No deviations or non-conformances were found.There were no other complaints found related to lot one opened sample and four unopened devices were returned from the customer for review.A visual inspection was performed on the returned opened product, and it was found that the pincer and tri tips were fully intact but the pincer was flattened, inhibiting it from properly obtaining a sample.The complaint was confirmed.The remaining devices were opened and test fired five times each.No issues were noted with the function of the devices.There are stringent computer and photographic inspections that ensure the pincer is not deformed during the manufacturing process and has the proper radius.Capa ca-0042 has been opened to investigate the issue in detail and it is under effectiveness phase.

• Brand Name: BIOPINCE ULTRA FULL CORE BIOPSY INSTRUMENT 18GA X 10CM
• 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: 20085439
• Report Number: 0001625425-2024-01088
• Device Sequence Number: 18058327
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2024

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: 360-1080-02
• Device Lot Number: 11561544
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2024
• Supplement Date Received by Manufacturer: 10/18/2024
• Initial Report FDA Received Date: 08/28/2024
• Supplement Report FDA Received Date: 11/08/2024
• 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