MAUDE Adverse Event Report: LSI SOLUTIONS COR-KNOT; COR-KNOT, 5MM/14CM

Model Number 030884

Device Problem Difficult to Open or Close (2921)

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

Event Date 01/28/2014

Event Type  No Answer Provided  

Event Description

Lsi solutions cor-knot device not closing knots tightly.Two (2) 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.

• Brand Name: COR-KNOT
• Type of Device: COR-KNOT, 5MM/14CM
• Manufacturer (Section D): LSI SOLUTIONS; victor NY 14564
• MDR Report Key: 3603294
• MDR Text Key: 4095263
• Report Number: MW5034131
• Device Sequence Number: 1
• Product Code: HCF
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/28/2014
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2015
• Device Model Number: 030884
• Device Catalogue Number: 030884
• Device Lot Number: 6764
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 84 YR