MAUDE Adverse Event Report: LSI SOLUTIONS, INC. COR-KNOT MIS; INSTRUMENT, LIGATURE PASSING AND KNOT TYING

Model Number	030800
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/25/2018
Type of Reportable Event	Malfunction
Event or Problem Description
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.".

• Brand Name: COR-KNOT MIS
• Common Device Name: INSTRUMENT, LIGATURE PASSING AND KNOT TYING
• Manufacturer (Section D): LSI SOLUTIONS, INC.; 7796 victor-mendon rd.; victor NY 14564
• MDR Report Key: 8124034
• Report Number: 8124034
• Device Sequence Number: 1722075
• Product Code: HCF
• UDI-Device Identifier: 00850200006100
• UDI-Public: (01)00850200006100
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 11/27/2018
• Report Date (Section F): 11/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 030800
• Device Catalogue Number: 030800
• Device Lot Number: 729203
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 12/03/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 69
• Date Report Sent to FDA: 11/27/2018