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

Model Number	360-1080-03
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/30/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Biopince biospy gun returned a good initial sample on a pelvic transplanted kidney biopsy, but second and third passes were empty.Bard biopsy device was used to achieve a second sample.Other surgeons reported similar problems in the past couple of days.Cytology tech for today's case confirmed that many providers are having this same issue with this particular brand of biopsy device.I suspect, but cannot confirm, that the pincer mechanism is malfunctioning and not completely severing the sample.Manufacturer response for biopsy needle, (brand not provided) (per site reporter).Unsuccessful attempt to reach out argon rep.

• 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: 16731815
• Report Number: 16731815
• Device Sequence Number: 12473392
• Product Code: KNW
• UDI-Device Identifier: 00886333224012
• UDI-Public: (01)00886333224012(17)260301(10)11466588
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/06/2023
• Report Date (Section F): 04/06/2023

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: 360-1080-03
• Device Catalogue Number: 360-1080-03
• Device Lot Number: 11466588
• 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: 04/13/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/13/2023
• 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: Male
• Patient Weight: 81 KG
• Date Report Sent to FDA: 04/06/2023