MAUDE Adverse Event Report: LSI SOLUTIONS, INC. TK® TI-KNOT® DEVICE; INSTRUMENT, LIGATURE PASSING AND KNOT TYING

Model Number	030404
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/30/2019
Type of Reportable Event	Malfunction
Event or Problem Description
During procedure, surgeon could not load the tk ti-knot needle into the handle.Surgeon said that the hole was too small for the device to fit.The system would not allow the needle to load into it.2 different needles were tried without success.Another handle was opened and used without any issue loading needles.No patient harm.

• Brand Name: TK® TI-KNOT® DEVICE
• Common Device Name: INSTRUMENT, LIGATURE PASSING AND KNOT TYING
• Manufacturer (Section D): LSI SOLUTIONS, INC.; 7796 victor-mendon road; victor NY 14564
• MDR Report Key: 8960567
• Report Number: 8960567
• Device Sequence Number: 19437429
• Product Code: HCF
• UDI-Device Identifier: 00850200006094
• UDI-Public: (01)00850200006094(17)210228(10)743829
• 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: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 07/31/2019
• Report Date (Section F): 07/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 030404
• Device Catalogue Number: 030404
• Device Lot Number: 743829
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 09/04/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 97
• Date Report Sent to FDA: 07/31/2019