MAST QUADRANT RETRACTOR SYSTEM

Description of Event or Problem

IT WAS REPORTED THAT DURING SURGERY THE SURGEON WAS BURNED THREE TIMES BY THE LIGHT SOURCE AND THEN THE LIGHT STOPPED FUNCTIONING. REPORTEDLY, THE BURNS WERE NOT SEVERE AND DID NOT MELT THE SURGEON¿S GLOVES OR LEAVE A MARK ON THE SKIN, BUT IT WAS MORE SHOCKING AND UNEXPECTED. THE INCIDENT ADDED TIME TO THE PROCEDURE AS THE SURGEON HAD TO REGAIN COMPOSURE EACH TIME. AFTER THE LIGHT STOPPED FUNCTIONING THERE WAS NO BACKUP SO THE SURGEON HAD TO RELY ON HIS HEAD LAMP AND OVERHEAD LIGHTS WHICH WASN¿T IDEAL. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

Additional Manufacturer Narrative

(B)(4): VISUAL REVIEW OF THE INSTRUMENT IDENTIFIED ILLUMINATOR LIGHT SOURCE FITTING THAT APPEARED TO BE EXPOSED TO HIGH HEAT, AS EVIDENCE BY DISCOLORATION OF THE OPTICAL FIBERS AT THE FITTING AND MELTING OF BOTH THE EXTERNAL SHEATH AND INTERNAL OPTICAL FIBERS. THE DAMAGE IS CONSISTENT WITH EXCEEDING POWER LIMITS OF THE INSTRUMENT DURING USAGE.