InjuryFSZ
METRX SYSTEM
Received Feb 18, 2011 · Event occurred Jan 21, 2011
Report 1030489-2011-00154 · MDR key 1996515
Device
Generic name
Light, Surgical, Carrier
Manufacturer
Medtronic Sofamor Danek Instrument ManufacturingModel number
NACatalog number
9560702
Lot number
NA
Product problems
- Thermal Decomposition of Device
Patient
Not reported
- Burn(s)
Narrative
Additional Manufacturer Narrative
IT IS UNKNOWN WHAT TREATMENT THE PATIENT IS RECEIVED. (B)(4). DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. WE ARE UNABLE TO DETERMINE THE CAUSE OF THE EVENT.
Description of Event or Problem
IT WAS REPORTED THAT THE PATIENT WAS BURNED BY THE COUPLING BETWEEN THE LIGHTSOURCE AND THE CABLE. IT IS UNKNOWN THE SEVERITY OF THE BURN. HOWEVER NO OTHER PATIENT COMPLICATIONS WERE REPORTED DURING AND AFTER THE SURGERY.