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	09/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Over 70-year-old patient with history of severe mitral regurgitation underwent mitral valve repair.When scrub nurse was loading the suture threader on the device, carrier not loading flush on the device.Never inserted or used on the patient.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: 20480866
• Report Number: 20480866
• Device Sequence Number: 18244206
• Product Code: HCF
• UDI-Device Identifier: 00850200006292
• UDI-Public: (01)00850200006292
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 09/25/2024
• Report Date (Section F): 09/25/2024

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: 4366271
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 4 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/18/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/18/2024
• 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: 2 MO
• Patient Sex: Female
• Patient Weight: 110 KG
• Date Report Sent to FDA: 09/25/2024