MAST QUADRANT RETRACTOR SYSTEM

Additional Manufacturer Narrative

(B)(4): THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION.

Description of Event or Problem

IT WAS REPORTED THAT DURING THE SURGERY, THE DOCTOR NOTED THAT ILLUMINATION SYSTEM WAS NOT WORKING EFFECTIVELY WHILE PERFORMING THE DISC PREPARATION. SOMETIME HAD PASSED AND THE ORTHOPEDIC RESIDENT GRABBED THE THREADED INTERFACE OF THE ILLUMINATION DEVICE AND LIGHT SOURCE CABLE. IT WAS SO HOT TO THE TOUCH THAT IT NEARLY BURNED THROUGH HIS SURGICAL GLOVE. HE WAS NOT HARMED IN ANY WAY. THE DOCTOR HAD NOTICED UNDER CLOSE INSPECTION THAT THE METAL THREADED INTERFACE THAT CONNECTS TO THE BLACK PLASTIC ILLUMINATION CABLE HAD MELTED. HE IMMEDIATELY REQUESTED THAT THE LIGHT SOURCE BE SHUT OFF. THE METAL INTERFACE EVENTUALLY COOLED DOWN. THERE WAS NO REPORTED NEGATIVE EFFECT TO THE SUCCESS OF THE PROCEDURE AND THE PATIENT WAS NOT HARMED IN ANY WAY.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: THE INSTRUCTION FOR USE OF THE DEVICE STATES: ¿THE RECOMMENDED LIGHT SOURCE UTILIZES 100W LIGHT SOURCES AND 5MM FIBER OPTIC CABLES. USE OF LARGER CABLES AND/OR HIGHER WATTAGE LIGHT SOURCES MAY RESULT IN HIGH TEMPERATURES ON THE METAL CONNECTION TO THE LIGHT CABLE, WHICH MAY RESULT IN INJURY TO PATIENT OR STAFF AND DAMAGE TO PRODUCT. REDUCE INTENSITY LEVELS ON HIGH WATT LIGHT SOURCES/LARGE LIGHT CABLES AND TAKE PRECAUTIONS TO PROTECT PATIENT AND STAFF FROM INJURY.¿ VISUAL REVIEW OF THE INSTRUMENT IDENTIFIED ILLUMINATOR LIGHT SOURCE FITTING THAT APPEARED TO BE EXPOSED TO HIGH HEAT, AS EVIDENCE BY DISCOLORATION AND MELTING OF THE OPTICAL FIBERS AT THE LIGHT SOURCE FITTING. THE ABOVE OBSERVATIONS ARE CONSISTENT WITH EXCEEDING POWER LIMITS OF THE INSTRUMENT DURING USAGE.