0 OBSOLETE, USE 00-LX300-TSYS-13
Received Feb 8, 2017 · Event occurred Jan 5, 2017
Report 2523190-2017-00008 · MDR key 6312956
Device
Product problems
- Smoking
- Smoking
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
ON 1/27/2017 INTEGRA INVESTIGATION COMPLETED. METHOD: FAILURE ANALYSIS, DEVICE HISTORY EVALUATION RESULTS: FAILURE ANALYSIS - COMPLAINT IS UNCONFIRMED; THIS IS DUE TO THE PRODUCT NOT BEING RETURNED FOR REVIEW. DEVICE HISTORY EVALUATION - NONCONFORMING PRODUCT REPORT / NONCONFORMING MATERIAL REPORT HISTORY: NONE. VARIANCE AUTHORIZATION / DEVIATION HISTORY: NONE. ENGINEERING CHANGE ORDER / MANUFACTURING CHANGE ORDER HISTORY: NONE. CORRECTIVE ACTION PREVENTIVE ACTION HISTORY: NONE. HEALTH HAZARD EVALUATION HISTORY: NONE. CONCLUSION: ROOT CAUSE CANNOT BE DETERMINED DUE TO THE LACK OF INFORMATION RECEIVED TO PERFORM A COMPLETE INVESTIGATION. PRODUCT HAS NOT BEEN RETURNED FOR EVALUATION.
Description of Event or Problem
MEDWATCH REPORT: (B)(4) FORWARDED BY FDA. "IN THE OPERATING ROOM, SMOKE WAS DETECTED FROM THE REAR OF THE LIGHT SOURCE DURING OPEN HEART SURGERY." NO HARM DONE. CUSTOMER IS NOT RETURNING PRODUCT.