MAUDE Adverse Event Report: ARGON MEDICAL DEVICES BIOPINCE ULTRA FULL CORE BIOPSY INSTRUMENT (18GA X 15CM); INSTRUMENT, BIOPSY

Model Number	360-1580-03
Medical Device Problem Code	Misfire (2532)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A radiologist attempted to use the side button to fire the device during a renal biopsy.The side button failed; the physician then adjusted his hand to use the trigger at the back of the needle and the device deployed without any buttons being pushed.
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.Eleven samples were returned from the customer for review.A visual inspection was performed on the returned products, and no damage was found.The devices were test fired five each and functioned as designed.The devices were disassembled, and it was found that there was excess glue on the front trigger arms.This could cause it to be difficult to fire the device from the front trigger.The complaint was confirmed.A failure investigation has been initiated to determine the root cause of this issue and determine corrective actions.Additional information provided in h.3., h.6.And h.11.

• Brand Name: BIOPINCE ULTRA FULL CORE BIOPSY INSTRUMENT (18GA 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: 22047245
• Report Number: 0001625425-2025-01017
• Device Sequence Number: 8908243
• Product Code: KNW
• UDI-Device Identifier: 00886333224036
• UDI-Public: (01)00886333224036(17)280116(10)11605068
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: Other,Consumer
• 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: 360-1580-03
• Device Lot Number: 11605068
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2025
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2025
• Supplement Date Received by Manufacturer: 07/03/2025
• Initial Report FDA Received Date: 05/19/2025
• Supplement Report FDA Received Date: 07/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/16/2025
• 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: 36 YR
• Patient Sex: Male