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

Model Number	030800
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The device is not working, especially in the tip part when attached to the cor-knot.

• Brand Name: COR-KNOT
• 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: 18273740
• Report Number: 18273740
• Device Sequence Number: 6166463
• 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: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 11/27/2023
• Report Date (Section F): 11/27/2023

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: 1567351
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 12/06/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/06/2023
• 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 Sex: Female
• Patient Weight: 63 KG
• Patient Race: White
• Date Report Sent to FDA: 11/27/2023