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

Model Number	360-1580-01
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/18/2018
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a renal biopsy and after the first firing there were two pieces of metal exposed.

• Brand Name: BIOPINCE¿ 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: 7482741
• Report Number: 7482741
• Device Sequence Number: 147762
• Product Code: KNW
• UDI-Device Identifier: 00886333004355
• UDI-Public: (01)00886333004355
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/27/2018
• Report Date (Section F): 04/27/2018

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: Physician
• Device Expiration Date: 03/01/2021
• Device Model Number: 360-1580-01
• Device Catalogue Number: 360-1580-01
• Device Lot Number: 11210164
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 2 MO
• Event Location: Hospital
• Date Report to Manufacturer: 04/27/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 25 YR
• Date Report Sent to FDA: 04/27/2018