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 Patient Involvement (2645)
Date of Event	07/01/2019
Type of Reportable Event	Malfunction
Event or Problem Description
As operating room staff were setting up for a surgical case, they tried opening the lsi solutions tk ti-knot (ref 030404, lot # 739987) device packaging but it wouldn't open properly.The packaging wouldn't peel open as it normally would, but rather the paper cover was peeling in half.Since the staff couldn't guarantee the sterility of the contents of the package/device, they couldn't use the device and had to open a second device for the case.

• 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: 8960536
• Report Number: 8960536
• Device Sequence Number: 16762007
• Product Code: HCF
• UDI-Device Identifier: 00850200006094
• UDI-Public: (01)00850200006094(17)210131(10)739987
• 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): 08/01/2019
• Report Date (Section F): 08/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: 030404
• Device Catalogue Number: 030404
• Device Lot Number: 739987
• 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
• Date Report Sent to FDA: 08/01/2019