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

Model Number	031350
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Patient was taken to the operating room and placed on the table in the supine position.General anesthesia was induced; lines and monitoring devices were placed.Patient's chest was prepped and draped in the usual sterile fashion.When it was time to do the avr [aortic valve replacement], the aortic valve was inspected and there appeared to be a calcified lesion distorting the right coronary leaflet.Near the end of the avr, sutures were placed through the sewing cuff of the valve and fastened in place using cor-knots.However, the firing mechanism stopped at 8 and it stopped cutting wire.The device was exchanged for another one and the procedure was completed without any further incident.No patient harm.

• Brand Name: COR-KNOT MINI®
• 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: 23554375
• Report Number: 23554375
• Device Sequence Number: 9659927
• Product Code: HCF
• UDI-Device Identifier: 00850200006292
• UDI-Public: (01)00850200006292(17)280630(11)250714(10)8631477
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/18/2025
• Report Date (Section F): 09/18/2025

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: 031350
• Device Catalogue Number: 031350
• Device Lot Number: 8631477
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 2 MO
• Event Location: Hospital
• Date Report to Manufacturer: 11/14/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/14/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 89 KG
• Date Report Sent to FDA: 09/18/2025