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	09/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
After proper identification, patient was brought to the operating room and placed on the table in supine position.General anesthesia was given, insertion of swan-ganz catheter and chest, abdomen and legs were prepped and draped in sterile fashion.During the procedure for the aortic valve, cor-knot was used to tie all the sutures.However, the cor-knot did not complete firing.The device was exchanged for another similar device and the operation was completed without any further incidence.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: 23554595
• Report Number: 23554595
• Device Sequence Number: 10160787
• 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): 09/17/2025
• 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: 86 YR
• Patient Sex: Male
• Patient Weight: 65 KG
• Date Report Sent to FDA: 09/18/2025