MILLENNIUM SURGICAL FIBER OPTIC RETRACTOR
Received May 27, 2016 · Event occurred Mar 29, 2016
Report 5684654 · MDR key 5684654
Device
Product problems
- Overheating of Device
- Smoking
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
DURING THE SURGICAL PROCEDURE THE LIGHTED BREAST RETRACTOR (#72-9851F, E0316) CONNECTED TO LIGHT BOX #137287 VIA LIGHT CORD #233-050-064 HEATED AT THE TIP OF THE RETRACTOR AND THE SURGICAL TOWEL ON THE MAYO STAND TO THE POINT OF VISIBLE SMOKE. THE RETRACTOR HAD BEEN ON THE MAYO STAND FOR "2 TO 3 MINUTES" PER THE STAFF. THE STAFF ALSO NOTED THE CONNECTION BETWEEN THE LIGHT CORD AND THE RETRACTOR WAS HOT TO THE TOUCH EVEN THROUGH THE SURGICAL GLOVES. THERE WAS NO PATIENT INJURY. EVALUATION BY CLINICAL ENGINEERING DID NOT FIND ANY DEFECTS OR PROBLEMS WITH THE EQUIPMENT. THE IFU FOR THE EQUIPMENT STATES "FIRE HAZARD. NEVER DRAPE OR COVER THE END OF ANY FIBER-OPTIC CABLE WITH ANYTHING FLAMMABLE." MANUFACTURER RESPONSE FOR FIBER OPTIC RETRACTOR, MILLENNIUM SURGICAL (PER SITE REPORTER): MANUFACTURER PROVIDED INSTRUCTIONS FOR USE (IFU).