COR-KNOT MIS 030800

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-03 for COR-KNOT MIS 030800 manufactured by Lsi Solutions, Inc..

Event Text Entries

[129027117] The cor-knot device started breaking the suture and the grommet broke inside the unit. It released the grommet prematurely when engaging the device. The parts were retrieved and isolated from the case. (the broken grommet is inside the package). There were no complications. Notes from the operative report: "... The annulus was encircled with 13 pledgeted 2-0 ethibond sutures. These were passed through the valve. The valve was seated and tied down with a cor-knot device. The aorta was closed in 2 layers of 4-0 prolene pledgeted at either end. "
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 8124034
• MDR Report Key: 8124034
• Date Received: 2018-12-03
• Date of Report: 2018-11-27
• Date of Event: 2018-10-25
• Report Date: 2018-11-27
• Date Reported to FDA: 2018-11-27
• Date Reported to Mfgr: 2018-12-03
• Date Added to Maude: 2018-12-03
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: COR-KNOT MIS
• Generic Name: INSTRUMENT, LIGATURE PASSING AND KNOT TYING
• Product Code: HCF
• Date Received: 2018-12-03
• Model Number: 030800
• Catalog Number: 030800
• Lot Number: 729203
• Operator: HEALTH PROFESSIONAL
• Device Availability: *
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: LSI SOLUTIONS, INC.
• Manufacturer Address: 7796 VICTOR-MENDON RD. VICTOR NY 14564 US 14564

Patients

Patient Number	Treatment	Outcome	Date
1	0		2018-12-03