MalfunctionHCF

COR-KNOT MINI®

Received Nov 15, 2024 · Event occurred Sep 4, 2024

Report 20694475 · MDR key 20694475

Device

Generic name

Instrument, Ligature Passing And Knot Tying

Manufacturer

Lsi Solutions, Inc.

Model number

031350

Catalog number

031350

Lot number

4189099

Patient

78 YR · Male

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

Narrative

Description of Event or Problem

COR KNOT DEVICES NOT LOADING PROPERLY. RELOAD NOT SEATING FULLY INTO DEVICE, DEVICE GRINDING. NO PATIENT HARM. OPENED NEW DEVICE TO COMPLETE THE CASE. MANUFACTURER RESPONSE FOR AUTOMATED SUTURE FASTENING SYSTEM, LSI SOLUTIONS INC (PER SITE REPORTER). PROVIDED RGA INFORMATION AND WILL CREDIT UPON RECEIPT OF DEFECTIVE PRODUCT.