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

Model Number 360-1580-01

Device Problem Break (1069)

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

Event Date 12/15/2020

Event Type  malfunction  

Event Description

While using the biopince biopsy device, the handle broke and we were unable to obtain adequate samples.This required us to open another device and enter the liver a second time.The patient did not have any side-effects as a result of this.

• Brand Name: BIOPINCE 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: 11228756
• MDR Text Key: 228621649
• Report Number: 11228756
• 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: Nurse
• Type of Report: Initial
• Report Date: 01/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 360-1580-01
• Device Catalogue Number: 360-1580-01
• Device Lot Number: 11279226
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/19/2021
• Event Location: Hospital
• Date Report to Manufacturer: 01/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 9490 DA
• Patient Weight: 52