MalfunctionHCF
COR-KNOT MINI DEVICE
Received Aug 15, 2024 · Event occurred Aug 6, 2024
Report MW5158539 · MDR key 19998712
Device
Generic name
Instrument, Ligature Passing And Knot Tying
Manufacturer
Lsi SolutionsModel number
031350Catalog number
031350
Lot number
2327959
Patient
59 YR · Male
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
COR-KNOT DEVICE FAILED TO CUT THE VALVE SUTURE DURING PROCEDURE AND HAD TO BE REPLACED WITH ANOTHER KIT.