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

Model Number 030404

Device Problem Difficult to Open or Close (2921)

Patient Problem No Patient Involvement (2645)

Event Date 07/01/2019

Event Type  malfunction  

Event 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
• Type of Device: INSTRUMENT, LIGATURE PASSING AND KNOT TYING
• Manufacturer (Section D): LSI SOLUTIONS, INC.; 7796 victor-mendon road; victor NY 14564
• MDR Report Key: 8960536
• MDR Text Key: 156484240
• Report Number: 8960536
• Device Sequence Number: 1
• Product Code: HCF
• UDI-Device Identifier: 00850200006094
• UDI-Public: (01)00850200006094(17)210131(10)739987
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2019
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 030404
• Device Catalogue Number: 030404
• Device Lot Number: 739987
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/01/2019
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 09/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1