MalfunctionHCF

COR-KNOT®

Received Sep 16, 2025 · Event occurred Aug 26, 2025

Report 23062249 · MDR key 23062249

Device

Generic name

Instrument, Ligature Passing And Knot Tying

Manufacturer

Lsi Solutions, Inc.

Model number

030800

Catalog number

030800

Lot number

958788

Product problems

Loose or Intermittent Connection
Failure to Fire

Patient

NA · Male

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

Narrative

Description of Event or Problem

DURING A CARDIOTHORACIC SURGERY, THE COR-KNOT DEVICE DID NOT FIRE CORRECTLY RESULTING IN THE THE SUTURES BEING LOOSE AND REQUIRING REMOVAL AND REPLACEMENT OF THE SUTURES. IN ADDITION, IT REQUIRED EXTRA SUTURES AND ADDITIONAL CROSS-CLAMP TIME.