Description of Event or Problem · 1
DURING THE FIRST HALF HOUR OF AN ENDOSCOPIC LASER STONE EXTRACTION, THE LASER FIBER FAILED, REQUIRING REPLACEMENT OF THE FIBER IN ORDER TO PROCEED WITH SURGERY. THE INITIAL ATTEMPT TO REMOVE THE FIBER REVEALED THAT AN APPROXIMATELY 0.5 METER SECTION OF THE FIBER HAD SEPARATED FROM THE PROXIMAL FIBER AND WAS STILL WITHIN THE PATIENT. THE REMAINDER OF THE FIBER WAS ENDOSCOPICALLY EXTRACTED. NO INJURY TO PATIENT OR STAFF OCCURRED. THIS WAS THE THIRD LASER FIBER BREAK IN A MONTH BUT THE FIRST INSIDE THE PATIENT. LASER POWER LEVELS IN USE WERE WELL UNDER THE POWER RATINGS FOR THE REUSABLE FIBERS. A REVIEW OF THE MANUFACTURER'S RECCOMMENDATIONS FOR PROCESSING THESE REUSABLE FIBERS REVEALED THAT THERE ARE LIMITS ON HOW TIGHTLY THEY CAN BE LOOPED FOR PACKAGING AND STORAGE. PACKAGING OF THESE FIBERS AT OUR FACILITY WAS BEING PERFORMED WITH TIGHTER LOOPS THAN RECOMMENDED WHICH MIGHT BE CONTRIBUTING TO THE FAILURES.MECHANICAL FAILURE OF THE LASER FIBER INTERRUPTED THE SURGICAL PROCEDURE. THIS FAILURE POTENTIALLY COULD HAVE RESULTED IN MISDIRECTED LASER ENERGY INJURY TO THE PATIENT OR STAFF. ALSO A VERY SHORT PIECE OF FIBER BEING LEFT INSIDE THE PATIENT MIGHT NOT HAVE BEEN NOTICED. MANUFACTURER RESPONSE (AS PER REPORTER) FOR SURGICAL LASER RESUABLE FIBER, SLIMLINETHE MANUFACTURER HAS INDICATED THAT CONVERSION TO A SINGLE USE FIBER SHOULD ELIMINATE THIS OCCURRENCE.