MalfunctionHCF

COR-KNOT MINI®

Received Apr 15, 2025 · Event occurred Mar 7, 2025

Report 21839600 · MDR key 21839600

Device

Generic name

Instrument, Ligature Passing And Knot Tying

Manufacturer

Lsi Solutions, Inc.

Model number

031350

Lot number

6228735

Product problems

Mechanical Problem
Therapeutic or Diagnostic Output Failure

Patient

NA · Male

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

Narrative

Description of Event or Problem

WHILE PERFORMING OPEN HEART SURGERY THE COR-KNOT DEVICE WAS BEING USED AND FAILED. TWO DEVICES COME IN THE KIT. ONE OF THEM FAILED COMPLETELY AND THE OTHER EVENTUALLY FAILED AS WELL. THEY WOULD NOT CRIMP CORRECTLY.