ODYSSEY NAVIGATOR DIODE LASER

Description of Event or Problem

OPERATOR OF DEVICE REPORTED THAT THE DEVICE HANDPIECE ACHIEVED EXCESSIVE TEMPERATURES, SUFFICIENT TO MELT THROUGH THE LATEX GLOVE THE OPERATOR WAS WEARING AND CAUSE A BURN ON THE OPERATOR'S HAND. THE DEVICE WAS BEING OPERATED AT IT'S MAXIMUM SETTING OF 3 WATTS OPTICAL OUTPUT AND WAS RUN IN CONTINUOUS MODE FOR APPROXIMATELY 1 MINUTE.

Additional Manufacturer Narrative

UPON VISUAL INSPECTION, A BROWN DISCOLORATION WAS OBSERVED ON THE FIBER CABLE, ABOUT 2MM FROM THE EDGE OF THE HANDPIECE. UPON ATTACHMENT TO THE LASER UNIT AND ACTIVATION OF THE AIMING BEAM, NO AIMING BEAM WAS OBSERVED EMITTING FROM THE END OF THE HANDPIECE. A RED ILLUMINATED SPOT WAS OBSERVED WITHIN THE FIBER CABLE AT THE SAME LOCATION AS THE BROWN DISCOLORATION. UPON ACTIVATION OF THE WORKING BEAM, NO OUTPUT POWER WAS MEASURED OUT THE END OF THE HANDPIECE. AFTER ONE MINUTE OF ACTIVATION, TEMPERATURE MEASUREMENTS AT THE ADJACENT END OF THE HANDPIECE WERE MONITORED AND PEAKED AT 97.1 DEGREES FAHRENHEIT. ALL OF THIS EVIDENCE INDICATES THE OPTICAL FIBER WAS BROKEN AT A LOCATION APPROXIMATELY 2MM FROM THE END OF THE HANDPIECE. A BREAK IN THIS LOCATION IS GENERALLY CAUSED BY EXCESSIVE STRAIN OR BENDING OF THE CABLE ADJACENT TO THE HANDPIECE. THE DEVICE OPERATOR'S MANUAL ALREADY CONTAINS STATEMENTS AND CAUTIONS REGARDING THE CARE AND HANDLING OF THE OPTICAL FIBER TO PREVENT UNACCEPTABLE STRAIN TO THE OPTICAL FIBER OR ITS CONNECTION POINTS. BECAUSE THESE LABELLING PRECAUTIONS ALREADY EXIST, NO FURTHER ACTION REGARDING MARKET ADVISORY OR CORRECTIVE ACTION ARE WARRANTED.