LIGHT-GUIDE CABLE, 2.8 MM, 3 M, CF TYPE

Additional Manufacturer Narrative

THE DEVICE EVALUATION IS ONGOING. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem

IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, WHILE USING THE LIGHT CABLE, THE TIP OF THE CAMERA HEAD WAS FOUND TO BE SCORCHED. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

Additional Manufacturer Narrative

UPDATED: H4, H6, H11 THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. BASED ON THE RESULTS OF THE INVESTIGATION, A DEFINITIVE ROOT CAUSE OF THE REPORTED HEAT GENERATION COULD NOT BE DETERMINED, HOWEVER, THE ISSUE WAS LIKELY DUE TO THE FIBER GLASS SLEEVE SERVING AS A STRAIN RELIEF BECAME TORN DUE TO A HIGH TENSILE LOAD AND BENDING STRESS. DUE TO TEARING OF THE TENSION RELIEF, THE PROTECTIVE HOSE, THE INNER HOSE AND/OR THE METAL COIL CAN SLIP OUT OF THE SLEEVE. IF THE METAL COIL SLIPS OUT, THE EXPOSED EDGE OF THE SLEEVE CAN CAUSE THE GLASS FIBERS TO BREAK, LEADING TO DETERIORATION OF THE LIGHT TRANSMISSION AND HEAT CONDUCTION. THE ISSUE IS THE RESULT OF USER HANDLING/MISHANDLING DUE TO EXCESSIVE BENDING AND TENSILE STRESS ON THE LIGHT GUIDE CABLE. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.