MAUDE Adverse Event Report: LSI SOLUTIONS LSI SOLUTIONS; FORNISEE

Model Number 110035

Device Problems Fire (1245); Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/31/2018

Event Type  malfunction  

Event Description

Light cord became dislodged from fornisee device, which resulted in a burned drape.This event meets the joint commission of an operating room fire, and could have resulted in permanent injury or death.

• Brand Name: LSI SOLUTIONS
• Type of Device: FORNISEE
• Manufacturer (Section D): LSI SOLUTIONS; victor NY 14564
• MDR Report Key: 7240755
• MDR Text Key: 98994782
• Report Number: MW5075034
• Device Sequence Number: 0
• Product Code: HEW
• Combination Product (y/n): N
• 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: 02/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2019
• Device Model Number: 110035
• Device Lot Number: 692269
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 46 YR