METRX SYSTEM
Received Jan 7, 2011 · Event occurred May 22, 2008
Report 1030489-2011-00021 · MDR key 1952966
Device
Generic name
Light, Surgical, Carrier
Manufacturer
Medtronic Sofamor Danek Usa, IncModel number
NACatalog number
9560702
Lot number
NA
Product problems
- Unintended Magnet Quench
- Improper or Incorrect Procedure or Method
Patient
36 YR
- Burn(s)
Narrative
Additional Manufacturer Narrative
(B)(4). DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. WE ARE UNABLE TO DETERMINE THE CAUSE OF THE EVENT. A REVIEW OF DEVICE HISTORY RECORDS IS NOT POSSIBLE AT THIS TIME WITHOUT ADDITIONAL DEVICE INFORMATION.
Description of Event or Problem
IT WAS REPORTED THAT THE PATIENT RECEIVED MINI-INVASIVE DISCECTOMY PROCEDURE AT L5-S1 TWO YEARS AGO AND A ILLUMINATE SYSTEM WAS USED AT THE SURGERY. DURING THE SURGERY, THE LIGHT SOURCE WHERE IT PLUGS IN WAS DRAPED ACROSS THE PATIENT. AFTER THE SURGERY, IT WAS NOTICED THAT THE PATIENT'S BACK BURNED BY THE CONNECTOR BETWEEN LIGHT SOURCE AND THE CABLE. THE BURN AREA WAS TREATED IN THE OR BEFORE THE PATIENT LEFT THE ROOM. THERE WAS A CIRCLE MARK LEFT WHERE THE PLUG WAS DRAPED OVER THE PATIENT. THE PATIENT REPORTEDLY RECEIVED THE POST-OP TREATMENT FOR THE BURN. REPORTEDLY, THE PATIENT HAD THE DERMATOLOGY ISSUES AFTER THE TREATMENT.