METRX SYSTEM
Received Feb 17, 2013 · Event occurred Feb 7, 2013
Report 1030489-2013-00526 · MDR key 2966043
Device
Generic name
Light, Surgical, Carrier
Manufacturer
Warsaw OrthopedicsCatalog number
9560702
Lot number
0222865W
Product problems
- Overheating of Device
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE LIGHT SOURCE CAUGHT ON FIRE DURING A MICRODISCECTOMY. NO PATIENT COMPLICATIONS WERE REPORTED. NO FURTHER DETAILS ARE KNOWN AT THIS TIME.
Additional Manufacturer Narrative
THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. ANALYSIS RESULTS ARE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.
Additional Manufacturer Narrative
(B)(6). (B)(4). NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT.
Additional Manufacturer Narrative
ANALYSIS OF THE RETURNED DEVICE SHOWS THAT VISUAL AND OPTICAL EXAMINATION OF THE RETURNED INSTRUMENT IDENTIFIED APPEARANCE OF PLASTIC OPTICAL FIBER STRANDS MELTED, CONSISTENT WITH EXCEEDING POWER LIMITS DURING USAGE, PER THE CAUTION LABEL ON THE OUTSIDE OF THE INSTRUMENT PACKAGING. THE ABOVE OBSERVATIONS ARE CONSISTENT WITH INAPPROPRIATE USAGE OF THE INSTRUMENT.