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

Model Number 360-1080-02

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/28/2023

Event Type  malfunction  

Event Description

Failure of argon medical biopince ultra full core biopsy instrument (ref # (b)(4)) with 18g x 10cm echogenic co-axial introducer needle (ref #(b)(4), lot # 11466721) manufacturer response for biopince biopsy device, biopince (per site reporter) user error.

• Brand Name: BIOPINCE ULTRA FULL CORE BIOPSY INSTRUMENT
• Type of Device: INSTRUMENT, BIOPSY
• Manufacturer (Section D): ARGON MEDICAL DEVICES, INC.; 1445 flat creek rd.; athens TX 75751
• MDR Report Key: 16875420
• MDR Text Key: 314647572
• Report Number: 16875420
• 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: 05/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 360-1080-02
• Device Catalogue Number: 360-1080-02
• Device Lot Number: 11466721
• 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: 05/02/2023
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 05/05/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 21900 DA
• Patient Sex: Female
• Patient Weight: 85 KG
• Patient Race: White