MAUDE Adverse Event Report: LSI SOLUTIONS INC.; NONE

Device Problem Difficult to Open or Close (2921)

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

Event Type  Other  

Manufacturer Narrative

The event information received by lsi solutions regarded cardiac surgery involving the cor-knot elite technology and reported the "cor-know device not closing knots tightly.Two devices in each box.The first device demonstrated this issue from the beginning.The second device demonstrated this same issue toward the end of its use." no patient harm was reported.Two devices were returned to our facility, decontaminated using routine protocol and evaluated by a senior engineer.One device performed within normal limits except it s purple lever did not spring back to its fully forward position without manual assistance and it was difficult to load.Examination of this device after disassembly revealed distortion of the internal crimping mechanism used to crimp titanium fasteners.While the second device also needed manual assistance to return the purple lever fully forward, it had no other findings.Both returned devices provided above usp standard knot strength.These findings do not interfere with either device's ability to crimp the titanium fasteners and trim suture.The spring activated lever return is not required for the device's intended use for crimping the titanium fastener and trimming suture.Except for sticking levers in both devices and difficulty loading in one device, all testing of the returned devices confirmed otherwise appropriate function as designed including excellent knot strength and consistent suture trimming.While the cause of the distorted crimping mechanism in one device remains unexplained, it appears to affect loading but not critical crimping and suture trimming.While inconvenient, these findings have not compromised the patient.

Event Description

Ref (b)(4).

• Type of Device: NONE
• Manufacturer (Section D): LSI SOLUTIONS INC.; 7796 victor-mendon rd.; victor NY 14564
• Manufacturer Contact: gloria schucker ; 7796 victor-mendon rd.; victor, NY 14564 ; 5858696633
• MDR Report Key: 3723813
• MDR Text Key: 15878766
• Report Number: 1320468-2014-00005
• Device Sequence Number: 1
• Product Code: HCF
• Combination Product (y/n): N
• PMA/PMN Number: K100593
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Date Manufacturer Received: 02/05/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1