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	06/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The cor-knot handle was found to malfunction.It would not close or dispense properly.The device was removed from the or.

• 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: 20199087
• Report Number: 20199087
• Device Sequence Number: 6815628
• Product Code: HCF
• UDI-Device Identifier: 00850200006292
• UDI-Public: (01)00850200006292(17)260930(11)231025(10)2360486
• 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): 08/30/2024
• Report Date (Section F): 08/30/2024

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: 2360486
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 09/12/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/12/2024
• 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: 86 YR
• Patient Sex: Unknown
• Patient Weight: 82 KG
• Date Report Sent to FDA: 08/30/2024