MAUDE Adverse Event Report: ARGON MEDICAL DEVICES, INC. BIOPINCE ULTRA FULL CORE BIOPSY INSTRUMENT; INSTRUMENT, BIOPSY

Model Number	370-1080-02
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	10/09/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Patient was here for a breast biopsy.The radiologist placed the first biopince device into the patient and attempted to collect tissue 3 separate times, and the tissue sample would not dispense from the biopince.Therefore, a second biopince device was opened.The second device deployed as expected, but when the radiologist opened the device to collect the sample, the handle broke.Therefore, a third device was opened to complete the biopsy successfully.Both devices have the ref#: 370-1080-02, lot#: 11488229, exp date: 2026-07-19.

• Brand Name: BIOPINCE ULTRA FULL CORE BIOPSY INSTRUMENT
• Common Device Name: INSTRUMENT, BIOPSY
• Manufacturer (Section D): ARGON MEDICAL DEVICES, INC.; 1445 flat creek rd.; athens TX 75751
• MDR Report Key: 18054720
• Report Number: 18054720
• Device Sequence Number: 12493731
• Product Code: KNW
• UDI-Device Identifier: 00886333224067
• UDI-Public: (01)00886333224067(17)260719(10)11488229
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 10/19/2023
• Report Date (Section F): 10/19/2023

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: 370-1080-02
• Device Catalogue Number: 370-1080-02
• Device Lot Number: 11488229
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 11/02/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/02/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female
• Date Report Sent to FDA: 10/19/2023