MalfunctionHCF

COR-KNOT MINI

Received Oct 18, 2024 · Event occurred Sep 20, 2024

Report 20480866 · MDR key 20480866

Device

Generic name

Instrument, Ligature Passing And Knot Tying

Manufacturer

Lsi Solutions, Inc.

Model number

031350

Catalog number

031350

Lot number

4366271

Patient

2 MO · Female

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

Narrative

Description of Event or Problem

OVER 70-YEAR-OLD PATIENT WITH HISTORY OF SEVERE MITRAL REGURGITATION UNDERWENT MITRAL VALVE REPAIR. WHEN SCRUB NURSE WAS LOADING THE SUTURE THREADER ON THE DEVICE, CARRIER NOT LOADING FLUSH ON THE DEVICE. NEVER INSERTED OR USED ON THE PATIENT. NO PATIENT HARM.