MalfunctionHCF

COR-KNOT MINI®

Received Nov 26, 2024 · Event occurred Oct 23, 2024

Report 20781946 · MDR key 20781946

Device

Generic name

Instrument, Ligature Passing And Knot Tying

Manufacturer

Lsi Solutions, Inc.

Model number

031350

Catalog number

031350

Lot number

4777-282

Patient

68 YR · Male

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

Narrative

Description of Event or Problem

NOT WORKING PROPERLY. MANUFACTURER RESPONSE FOR AUTOMATED SUTURE FASTENING SYSTEM, COR-KNOT (PER SITE REPORTER). FORMAL COMPLAINT LOGGED. PRODUCT RETURNED USING VENDOR'S FEDEX ACCT FOR INVESTIGATION.