MalfunctionGAD
MILLENNIUM SURGICAL FIBER OPTIC RETRACTOR
Received May 26, 2016 · Event occurred Jan 7, 2016
Report 5681349 · MDR key 5681349
Device
Product problems
- Temperature Problem
Patient
47 YR
- Partial thickness (Second Degree) Burn
- Partial thickness (Second Degree) Burn
Narrative
Description of Event or Problem
AT WOUND CLOSURE A BURN (BLISTER-2ND DEGREE) ON PATIENT'S UPPER LATERAL RIGHT CHEST, SIZE 3 X 1.5 CM WAS NOTICED. BURN WAS CAUSED BY THE USE OF A LIGHTED FIBER OPTIC BREAST RETRACTOR. WOUND WAS DRESSED WITH BACITRACIN OINTMENT, TELFA DRESSING AND TEGADERM PER MD ORDER. THE CONNECTION BETWEEN THE FIBER CABLE AND THE RETRACTOR GETS VERY HOT WHEN THE LIGHT IS ON.