InjuryKZF
MEDICAL ILLUMINATION INTERNATIONAL, INC.
Received Oct 7, 2002 · Event occurred Jul 24, 2001
Report 2028295-2002-00001 · MDR key 420509
Device
Generic name
Illuminator Iii
Manufacturer
Medical Illumination International, Inc.Model number
011314-1Catalog number
011314-1
Lot number
*
Product problems
- Filter
- Use of Device Problem
Patient
NA
- Burn(s)
Narrative
Description of Event or Problem
THE LIGHT BULB IN THIS LIGHT FAILED EITHER DURING OR BEFORE THE PROCEDURE BEGAN. A DOCTOR AT THE FACILITY WENT TO REPLACE THE BULB, BUT INSTEAD OF REMOVING THE HANDLE BASE SCREWS AS SPECIFIED IN THE LAMP REPLACEMENT PROCEDURE, HE REMOVED THE SPRINGS THAT HOLD THE HEAT FILTER IN PLACE AND REMOVED THE FILTER. THE BULB WAS REPLACED, BUT THE FILTER WAS NOT REPLACED. THE LIGHT WAS THEN USED ON THE PT, WITHOUT THE HEAT FILTER IN PLACE. DURING THE BREAST AUGMENTATION SURGERY, THE PT SUSTAINED BILATERAL THIRD DEGREE BURNS TO THEIR BREASTS.