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	Insufficient Information (4580)
Date of Event	04/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Patient was here for an ultrasound guided right breast biopsy.A biopince device was opened and tested prior to use and appeared to function properly.Three passes were done in the breast and specimens were not being captured.A second biopince device was opened and tested, and the biopsy was successfully completed.Defective device info: biopince 16 gauge x 10cm, lot # 11501605, ref # 370-1080-02.

• Brand Name: BIOPINCE ULTRA FULL CORE BIOPSY INSTRUMENT
• Common Device Name: INSTRUMENT, BIOPSY
• Manufacturer (Section D): ARGON MEDICAL DEVICES, INC.; 1445 flat creek road; athens TX 75751
• MDR Report Key: 19212341
• Report Number: 19212341
• Device Sequence Number: 6942254
• Product Code: KNW
• UDI-Device Identifier: 00886333224067
• UDI-Public: (01)00886333224067(17)261005(10)11501805
• 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): 04/11/2024
• Report Date (Section F): 04/11/2024

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: 370-1080-02
• Device Catalogue Number: 370-1080-02
• Device Lot Number: 11501805
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 04/30/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/30/2024
• 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 Age: 65 YR
• Patient Sex: Female
• Patient Weight: 110 KG
• Patient Race: White
• Date Report Sent to FDA: 04/11/2024