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

Model Number	360-1580-01
Medical Device Problem Code	Firing Problem (4011)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The reporter stated from the lead tech and physician's perspective: "dr.(b)(6) was the attending on the case for the renal bx.On the first pass, the device fired and collected a sample, but it was believed the device fired at 33mm instead of the selected 23mm throw length.The device was observed and the throw length adjuster was still on the 23 mm throw length.A second pass was done and measurement on the us machine showed the device did fire at 33 mm instead of the selected 23, and the throw length adjuster was still at the selected 23 mm.A new device was opened, tested, and used for the remained of the bx.That device was inspected by dr.(b)(6) and dr.(b)(6) as well, and they all agreed the device was firing on the 33mm length even though the throw length adjuster was on the 23 mm throw.When looking back at the us images, it looks like the device jumps back and then forward when fired.Two other devices of that lot we opened and tested and appeared to be fine and firing correctly at the 23 mm throw." the customer does not have the needle used for the case with the initial issue, the resident discarded it.They have the label from the packaging.There is a video of the second throw on the case, as well as a still image of the approximate measurement of the throw.
Additional Manufacturer Narrative
The sample was returned to argon for investigation.The investigation is currently in progress.A follow-up report will be submitted upon investigation completion.
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 and eleven unopened samples were returned from the customer for review.A visual inspection of the opened device was performed, and no damage was found.The device was test fired five times and functioned as designed.The unopened device will be tested during the failure investigation study.The complaint is confirmed.A failure investigation has been initiated to determine the root cause of this issue, and implement any corrective actions needed.

• Brand Name: BIOPINCE FULL CORE BIOPSY INSTRUMENT 18G X 15CM
• Common Device Name: BIOPINCE
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek rd; athens TX 75751
• Manufacturer Contact: kelly mayer ; 1445 flat creek rd; athens, TX 75751 ; 9036759321
• MDR Report Key: 19662831
• Report Number: 0001625425-2024-01060
• Device Sequence Number: 12418109
• Product Code: KNW
• UDI-Device Identifier: 00886333224005
• UDI-Public: (01)00886333224005(07)270501(10)11570132
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2025

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: 360-1580-01
• Device Lot Number: 11570132
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2024
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2024
• Supplement Date Received by Manufacturer: 03/24/2025
• Initial Report FDA Received Date: 07/02/2024
• Supplement Report FDA Received Date: 04/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/06/2024
• 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