InjuryFSZ
METRX SYSTEM
Received Apr 14, 2017 · Event occurred Mar 21, 2017
Report 1030489-2017-00813 · MDR key 6492549
Device
Generic name
Light, Surgical, Carrier
Manufacturer
Warsaw OrthopedicsModel number
NACatalog number
9560802
Lot number
UNK
Product problems
- Overheating of Device
- Overheating of Device
Patient
Not reported
- Burn(s)
- Burn(s)
Narrative
Additional Manufacturer Narrative
THE PRODUCT IS NOT RETURNED TO MANUFACTURER FOR EVALUATION THEREFORE WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF EVENT.
Description of Event or Problem
IT WAS REPORTED THAT PATIENT UNDERWENT MINIMALLY INVASIVE SPINE DECOMPRESSION SURGERY. INTRA-OP, LIGHT BURNED THE PATIENT'S BACK. WHILE IN USE, LIGHT WAS LAYING ON PATIENTS BACK WITH RUBBER SAFETY PIECE OVER WHERE IT ATTACHES TO LIGHT SOURCE. AFTER CASE 'PA' STATED THAT THE LIGHT BURNED THE PATIENTS BACK.