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

Catalog Number 701218090

Device Problem Fluid/Blood Leak (1250)

Patient Problem Exposure to Body Fluids (1745)

Event Date 08/30/2016

Event Type  No Answer Provided  

Manufacturer Narrative

A review of the package dhr and inspection records was conducted and no similar concerns were found.The device was not returned for examination.Additional information regarding the procedure has not been provided.Based on the available information, a root cause could not be determined with confidence.

Event Description

As physician deployed device to obtain biopsy specimen, blood splashed through opening in handle into his face.

• Brand Name: SUPER CORE¿ BIOPSY SET
• Type of Device: BIOPSY INSTRUMENT
• Manufacturer (Section D): ARGON MEDICAL DEVICES, INC.; 1445 flat creek road; athens TX 75751
• Manufacturer (Section G): ARGON MEDICAL DEVICES, INC.
• Manufacturer Contact: gail smith ; 1445 flat creek road; athens, TX 75751 ; 2144368995
• MDR Report Key: 5981023
• MDR Text Key: 55790066
• Report Number: 1625425-2016-00059
• Device Sequence Number: 1
• Product Code: KNW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K974814
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 05/31/2021
• Device Catalogue Number: 701218090
• Device Lot Number: 11141075
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/30/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/25/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other