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

Model Number 030404

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/28/2017

Event Type  malfunction  

Event Description

The ti knot device would not cut the suture properly.A second ti-knot device was opened and worked as expected.Manufacturer response for disposable 5mm titanium knot placement device, lsi solutions (per site reporter): manufacturer provided complaint# to track the product evaluation.

• Brand Name: TK® TI-KNOT® DEVICE
• Type of Device: INSTRUMENT, LIGATURE PASSING AND KNOT TYING
• Manufacturer (Section D): LSI SOLUTIONS, INC.; 7796 victor-mendon rd.; victor NY 14564
• MDR Report Key: 6770292
• MDR Text Key: 81926509
• Report Number: 6770292
• Device Sequence Number: 0
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 04/30/2019
• Device Model Number: 030404
• Device Catalogue Number: 030404
• Device Lot Number: 616225
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/02/2017
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 08/02/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/07/2017
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 51 YR
• Patient Weight: 70