ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Received Jul 1, 2011 · Event occurred Jun 1, 2011
Report 1030489-2011-00845 · MDR key 2147664
Device
Generic name
Light, Surgical, Carrier
Manufacturer
Warsaw Orthopedic, Inc.Model number
NACatalog number
9560757
Lot number
0087041W
Product problems
- Thermal Decomposition of Device
- Unintended Magnet Quench
Patient
00041 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 IN THE PATIENT'S MEDICAL RECORDS THAT THE PATIENT UNDERWENT A PROCEDURE FOR L4-5, L5-S1 TLIF. AFTER PLACING THE INTERBODY CAGES AND WITHDRAWING THE RETRACTORS, IT WAS NOTICED THAT THE PATIENT HAD BURNS IN MULTIPLE AREAS WHERE IT HAD TOUCHED THE SKIN AT THE CONNECTION POINT. THE LIGHT SOURCE WAS IMMEDIATELY REMOVED. AFTER IMPLANT OF THE POSTERIOR HARDWARE THE INCISION WAS CLOSED AND THE BURNS WERE TREATED. MULTIPLE LINEAR BURNS WERE NOTED. THE BURNS WERE IRRIGATED AND ANY SKIN OVER THE TOP WAS DEBRIDED. THE WOUNDS WERE THEN DRESSED WITH ANTIBIOTIC OINTMENT, AND THEN XEROFORM AND A STERILE DRESSING WAS PLACED OVER THE BURN AREAS. POST-OP THE PATIENT WAS TREATED BY A PLASTIC SURGEON FOR SCAR REVISION.
Description of Event or Problem
IT WAS REPORTED THAT THE PATIENT SUFFERED BURNS ON THE BACK FROM THE RADIANCE ILLUMINATION KIT GETTING EXTREMELY HOT AT THE CONNECTION POINT TO THE LIGHT CABLE OF THE 300 WATT LIGHT SOURCE.