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

Device Problems Use of Device Problem (1670); Defective Device (2588)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/29/2019

Event Type  malfunction  

Event Description

Soft tissue biopsy with ultrasound guidance using biopince which did not retrieve tissue samples as indicated.Used 3 devices, did 12 passes.

• Brand Name: BIOPINCE¿ FULL CORE BIOPSY INSTRUMENT
• Type of Device: INSTRUMENT, BIOPSY
• Manufacturer (Section D): ARGON MEDICAL DEVICES, INC.; 1445 flat creek road; athens TX 75751
• MDR Report Key: 9117415
• MDR Text Key: 160021461
• Report Number: 9117415
• Device Sequence Number: 1
• Product Code: KNW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/31/2019
• Event Location: Hospital
• Date Report to Manufacturer: 09/25/2019
• Type of Device Usage: N
• Patient Sequence Number: 1