MalfunctionHCF

COR-KNOT MINI®

Received Sep 12, 2024 · Event occurred May 31, 2024

Report 20199251 · MDR key 20199251

Device

Generic name

Instrument, Ligature Passing And Knot Tying

Manufacturer

Lsi Solutions, Inc.

Model number

031350

Catalog number

031350

Lot number

2630486

Patient

42 YR · Male

No Clinical Signs, Symptoms or Conditions
No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

DURING THE SURGERY, THE COR-KNOT MINI DEVICE MALFUNCTIONED. THE DEPLOYMENT GUNS WERE ORIGINALLY WORKING. WITH CONTINUED USE, THEY STARTED TO JAM, AND THE DEVICE WAS REPLACED WITH ANOTHER NEW DEVICE. NO APPARENT PATIENT HARM.