METRX SYSTEM
Received May 27, 2011 · Event occurred Apr 13, 2011
Report 1030489-2011-00628 · MDR key 2105058
Device
Generic name
Light, Surgical, Carrier
Manufacturer
Warsaw Orthopedic, Inc.Model number
NACatalog number
9560702
Lot number
0135693W
Product problems
- Overheating of Device
Patient
00042 YR
- Superficial (First Degree) Burn
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT A MINI-INVASIVE SPINAL PROCEDURE. THE PATIENT HAD A RECTANGULAR BURN ON HIS BACK INTRAOPE RATIVELY WHERE THE LIGHT BOX CABLE MEETS THE LIGHT SOURCE. IT WAS DISCOVERED IMMEDIATELY AFTER SURGERY. THE BURN WAS ABOUT AN INCH AND A HALF AROUND. THE HOSPITAL CONFIRMS THAT THE LIGHT SOURCE WAS USED WITH A LIGHT BOX SETTING ON AROUND 300 WATTS. THE HOSPITAL STATED THAT THE STAFF WAS NOT AWARE OF THE WARNING LABEL ON THE PRODUCT PACKAGING THAT REFERENCES USING A 100 WATT LIGHT SOURCE. REPORTEDLY, THE PATIENT WAS TREATED AT THE OFFICE AND GIVEN A CREAM. NO OTHER PATIENT COMPLICATIONS WERE REPORTED.
Additional Manufacturer Narrative
DEVICE HISTORY RECORDS WERE REVIEWED. NO DOCUMENTATION WAS FOUND THAT WOULD INDICATE A NON-CONFORMANCE TO SPECIFICATIONS.
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.