MAUDE Adverse Event Report: NUVASIVE, INC. MAXCESS; LIGHT, SURGICAL, FIBEROPTIC

Lot Number BE4051

Device Problems Thermal Decomposition of Device (1071); Device Emits Odor (1425)

Patient Problem Insufficient Information (4580)

Event Date 05/04/2021

Event Type  No Answer Provided  

Event Description

As surgery started, a burning smell was noticed coming from a disposable item that was burning at the tip inside the nuvasive maxcess light guide.

Event Description

As surgery started, a burning smell was noticed coming from a disposable item that was burning at the tip inside the nuvasive maxcess light guide.

• Brand Name: MAXCESS
• Type of Device: LIGHT, SURGICAL, FIBEROPTIC
• Manufacturer (Section D): NUVASIVE, INC.; 7475 lusk blvd; san diego CA 92121
• MDR Report Key: 11957241
• MDR Text Key: 254842961
• Report Number: 11957241
• Device Sequence Number: 1
• Product Code: FST
• 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,Followup
• Report Date: 05/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Lot Number: BE4051
• 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: 05/27/2021
• Date Report to Manufacturer: 06/08/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 26645 DA