25GA ILLUMINATED DIRECTIONAL LASER

Description of Event or Problem

A USER FACILITY IN FRANCE REPORTED THAT THE SURGEON BEGAN LASERING WITH THE USUAL FIXED ORANGE LASER PROBE (BL5295LC) ON THEIR WHITE VITRECTOMY MACHINE. FROM THE FIRST SHOT ON THE USUAL STARTING POWER OF 120MW THE END OF THE PROBE SMOKED, THE AIMING BEAM WENT FAINT AND THERE WAS NO UPTAKE DESPITE INCREASING THE POWER. THEY OPENED A NEW ORANGE PROBE AND THE EXACT SAME THING HAPPENED. THEY THEN TRIED A DIFFERENT BLACK EXTENDABLE LASER PROBE AND HAD THE SAME ISSUE STRAIGHT AWAY - SMOKE, WEAK AIMING BEAM AND NO UPTAKE. THEY THEN HAD TO THEN BRING THEIR GREY VITRECTOMY MACHINE IN, SWITCH OVER THE LASER TO THAT. SWAP FOOT PEDALS, FIND THE LASER KEY AND ATTACH THE FILTER WIRE. THE ONLY PROBE THEY HAD LEFT TO USE WAS A BLACK EXTENDABLE LASER PROBE AND THIS WORKED COMPLETELY FINE ON THE OTHER MACHINE. THE PATIENT WAS UNDER LOCAL ANESTHETIC AND AROUND 45 MINUTES ADDITIONAL SURGICAL TIME WAS ADDED ON TO SORT ALL OF THESE ISSUES. LUCKILY HE MANAGED REALLY WELL BUT SURGEON NOTED THAT IT COULD HAVE BEEN VERY DIFFICULT WITH AN UNCO-OPERATIVE OR NERVOUS PATIENT TO COPE WITH ALL OF THE ADDITIONAL TIME AND DISTURBANCE IT CAUSED IN THE THEATRE. THERE WAS NO PATIENT IMPACT.

Additional Manufacturer Narrative

THERE IS INSUFFICIENT INFORMATION TO EVALUATE THIS REPORT AS NO PRODUCT IS AVAILABLE. IT CANNOT CONCLUSIVELY BE DETERMINED WHAT CAUSED THE ADVERSE EVENT. THE TREND ANALYSIS, RISK ANALYSIS AND/OR DIRECTIONS FOR USE REVIEW WERE CONSIDERED ACCEPTABLE, WITH THE PRODUCT PERFORMING WITHIN ANTICIPATED RATES. DUE TO NO LOT NUMBER, THE DEVICE HISTORY RECORD REVIEW COULD NOT BE CONDUCTED. TYPICAL PRODUCT INSPECTION INCLUDES 100% VERIFICATION OF THE LASER AND ILLUMINATION OUTPUT/IMAGE OF EACH LASER PROBE TO ENSURE FUNCTIONALITY AND MEETS SPECIFICATIONS BEFORE THE PRODUCT LOT IS RELEASED. THE INVESTIGATION IS COMPLETE.