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

Model Number	1025461
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	07/14/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No product was returned for evaluation, no photographs or films provided, the patient's burn was treated at the time of the event, consisting of topical antibiotics, wound dressing and instructions for follow-up care/evaluation.The root cause of this reported event has not been determined; however, the available information suggests a light source incompatible with the nuvasive light cable was utilized.Labeling review: "the nuvasive maxcess light guide is intended to provide surgical site illumination.The maxcess light guide is compatible for use with light sources made with the following: xenon with lamp.Power rating of up to 300 watts, halogen with lamp power rating of up to 250 watts, or metal halide with lamp power rating of up to 100 watts.Any light source used with this cable should have a minimum of 90% ir filtering to prevent cable damage during use." "warning: maxcess light sources use high intensity lamps, which produce heat as well as brilliant light.The high brightness produced by the light source and the light output of the light guide cable can cause serious burns." "precautions: take precautions to verify that the fiber optic cable is appropriately suited for the light source." surgical facility retained the device.
Event or Problem Description
On (b)(6) 2016 a female patient underwent a posterior fixation procedure.Upon completion of the fixation, the retractor was removed and it was noted that the patient had incurred a full-thickness burn on the lower back beneath the retractor.

• Brand Name: NUVASIVE MAXCESS LIGHT GUIDE
• Common Device Name: LIGHT, SURGICAL, FIBEROPTIC
• Manufacturer (Section D): NUVASIVE, INC.; 7475 lusk blvd; san diego CA 92121
• MDR Report Key: 5880561
• Report Number: 2031966-2016-00057
• Device Sequence Number: 1241992
• Product Code: FST
• UDI-Device Identifier: 00887517183378
• UDI-Public: 00887517183378
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K042034
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Physician
• Device Model Number: 1025461
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2016
• Initial Report FDA Received Date: 08/16/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention