MAXENON XI 300-WATT XENON LIGHT SOURCE
Received Jan 16, 2014 · Event occurred Jul 23, 2013
Report 3005775121-2014-00001 · MDR key 3581602
Device
Product problems
- Insufficient Device Problem Information
Patient
Not reported
- Burn, Thermal
Narrative
Description of Event or Problem
(B)(4) REC'D NOTIFICATION ON 12/09/2013 THAT A PATIENT REC'D A BURN ON HIS LIP FROM A MEDTRONIC LARYNGOSCOPE DURING LARYNGEAL SURGERY. IT WAS REPORTED THAT THE LARYNGOSCOPE WAS CONNECTED TO A (B)(4) MAXENON XI 300-WATT XENON LIGHT SOURCE. (B)(4) HAS NOT BEEN CONTACTED BY THE FACILITY NOR WAS IT INFORMED OF AN ISSUE AT THE TIME OF THE OCCURRENCE AND HAS NOT REC'D THE LIGHT SOURCE FOR INVESTIGATION.
Additional Manufacturer Narrative
(B)(4) WAS THE DISTRIBUTOR OF THIS PRODUCT AT THE TIME OF THE OCCURRENCE. (B)(4) NO LONGER SELLS THIS PRODUCT. THE MANUFACTURER IS QED, INC. (B)(4) WAS NOT MADE AWARE OF THE OCCURRENCE BY THE FACILITY BUT BY THE MANUFACTURER OF THE LARYNGOSCOPE, (B)(6). (B)(4) HAS NOT REC'D THE LIGHT SOURCE TO CONDUCT AN INVESTIGATION. (B)(4) HAS NO RECORDS OF THE LIGHT SOURCE SENT IN FOR REPAIR AT ANY TIME NOR IS THERE A RECORD OF THE FACILITY PURCHASING REPLACEMENT LAMPS FROM (B)(4).