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	09/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Grommet did not tighten the suture down, it just cut the strings.Grommet cut suture as it was pulled through.

• 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: 20469862
• Report Number: 20469862
• Device Sequence Number: 12663280
• Product Code: HCF
• UDI-Device Identifier: 00850200006292
• UDI-Public: (01)00850200006292
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 09/24/2024
• Report Date (Section F): 09/24/2024

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
• Device Model Number: 031350
• Device Catalogue Number: 031350
• Device Lot Number: 4247403
• 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: 10/17/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/17/2024
• 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: 65 YR
• Patient Sex: Male
• Patient Weight: 95 KG
• Date Report Sent to FDA: 09/24/2024