LUMITEX MD LIGHTMAT SURGICAL ILLUMINATOR
Received Mar 16, 2015 · Event occurred Feb 11, 2014
Report MW5041509 · MDR key 4616989
Device
Generic name
Lightmat Surgical Illuminator
Manufacturer
Lumitex Md, IncCatalog number
UA 2550
Lot number
102659
Product problems
- Insufficient Device Problem Information
Patient
42 YR
- Full thickness (Third Degree) Burn
Narrative
Description of Event or Problem
A LIGHTMAT SURGICAL ILLUMINATOR BY LUMITEX MD (REF#UA2550, LOT 102659) WAS BEING USED DURING A BILATERAL MASTECTOMY PROCEDURE. THE ILLUMINATOR WAS CONNECTED TO A GYRUS ACMI G93 4 MM FIBER OPTIC LIGHT CABLE WHICH WAS CONNECTED TO AN INTEGRA LUXTEC 300 MLX XENON LIGHT SOURCE. THE SURGEON NOTED DURING THE FIRST PART OF THE PROCEDURE THAT THE ILLUMINATOR LIGHT WAS DIM. IT WAS THEN NOTED THAT THE SKIN OVER THE STERNUM HAD BEEN BURNED. THE METAL CONNECTION BETWEEN THE LIGHT CABLE AND THE ILLUMINATOR APPEARED TO HAVE COME IN CONTACT WITH THE SKIN IN THE AREA OF THE STERNUM. THE BURN COVERED AN ESTIMATED 4 X 3 CM AREA THAT APPEARED TO BE MOSTLY SUPERFICIAL AND PARTIAL THICKNESS. AN ESTIMATED 2 X 1 CM PORTIONS OF THE BURN INJURY APPEARED TO BE A FULL THICKNESS BURN. THERE WERE ALSO A COUPLE OF VERY SMALL, PUNCTATE AREAS OF BURN ON THE LEFT UPPER CHEST WALL.