MalfunctionHCF

COR-KNOT MINI®

Received Apr 25, 2025 · Event occurred Mar 4, 2025

Report 21908781 · MDR key 21908781

Device

Generic name

Instrument, Ligature Passing And Knot Tying

Manufacturer

Lsi Solutions, Inc.

Model number

031350

Catalog number

031350

Lot number

6228735

Product problems

Break

Patient

21 YR · Female

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

Narrative

Description of Event or Problem

SURGEON LOADED COR-KNOT MINI DEVICE QUICK LOAD UNITS. ONE OF THE UNITS BROKE IN HALF, ALL PIECES OBTAINED. NO PATIENT HARM. PER OR MATERIALS MANAGEMENT TEAM, A REPORT WAS FILED WITH THE COMPANY.