Description of Event or Problem · 1
DURING A PROCEDURE WHERE A LASER LITHOTRIPSY WAS GOING TO BE PERFORMED, A 230 UM LASER FIBER WAS OPENED. IT WAS CONNECTED TO THE HOLMIUM LASER AFTER IT PERFORMED ITS SELF-TEST AND PASSED. THE AIMING BEAM WAS SELECTED TO THREE BARS (MAXIMUM) AND THERE WAS NO AIMING BEAM SEEN ON THE SCREEN. THE LASER WAS PLACED ON "READY" AND IT APPEARED TO BEING WORKING BUT NO ACTUAL ENERGY WAS BEING PRODUCED TO BREAK UP THE STONE. THE LASER FIBER WAS REMOVED AND A DIFFERENT FIBER WAS ATTACHED TO THE MACHINE (SAME SIZE, DIFFERENT LOT NUMBER). WHEN THIS FIBER WAS CONNECTED AND THE AIMING BEAM SELECTED, AN AIMING BEAM WAS SEEN. WHEN THE SURGEON ACTIVATED THE FOOT PEDAL WHEN THE LASER WAS IN "READY" MODE, ENERGY WAS PRODUCED AND THE STONE WAS FRAGMENTED. RN WAS NOTIFIED AND THE REMAINING FIBERS WITH THE SAME LOT NUMBER AS THE FIBER THAT DID NOT WORK WERE SEQUESTERED. NO APPARENT HARM TO PATIENT. FIBER PERFORMED DURING TEST BUT NOT IN ACTUAL USE. ENERGY FROM THE BIOLITEC SOURCE DID NOT PASS THROUGH FIBER TO PERFORM DESIRED ACTION. ALL LIKE MODELS (BARE FIBER ASSEMBLY 230X 3.0 M, MODEL 101130, LOT A13-0036-B) REMOVED FROM SERVICE. WE ARE WAITING TO HEAR FROM MATERIALS MANAGEMENT TO DETERMINE WHAT SHOULD BE DONE WITH THE ITEMS.