VIDEO TELESCOPE "ENDOEYE", 10 MM, 30°, PAL, HD COMPATIBLE, AUTOCLAVABLE

Additional Manufacturer Narrative

THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION AND DEVICE EVALUATION. THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION, AND THE CUSTOMER'S COMPLAINT WAS CONFIRMED. 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, THE ROOT CAUSE COULD NOT BE DETERMINED. IT IS LIKELY THE REPORTED ISSUE OCCURRED DUE AN EXTERNAL FORCE APPLIED TO THE DEVICE FROM IMPROPER HANDLING. IN ADDITION, THE FOLLOWING NON-REPORTABLE MALFUNCTIONS WERE FOUND DURING THE DEVICE EVALUATION: THE LIGHT GUIDE LENS WAS DAMAGED, THE OUTER TUBE WAS DENTED, THE CABLE SLEEVE WAS DAMAGED, THE VIDEO CABLE WAS WORN/DAMAGED, THE PLUG UNIT COVER WAS CORRODED/DISCOLORED, THE IMAGE WAS DARK AND HAD A WHITE DOT, AND THE GRIP'S INNER SLEEVE WAS CRACKED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

Description of Event or Problem

IT WAS REPORTED TO OLYMPUS THAT A VIDEO TELESCOPE HAD A BROKEN SHEATH AND LG (LIGHT GUIDE) BUNDLE. THERE WAS NO PROCEDURE INVOLVED. THERE WAS NO PATIENT INJURY OR ADVERSE EVENT REPORTED TO OLYMPUS.

Additional Manufacturer Narrative

THE DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION AND REPAIR. THE INVESTIGATION IS STILL IN PROGRESS; THEREFORE, THE ROOT CAUSE OF THE REPORTED DEFECT CANNOT BE DETERMINED AT THIS TIME. HOWEVER, IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY. IN GENERAL, THE CUSTOMER IS REQUIRED TO INSPECT THE DEVICE FOR DEFECTS, CHECK THE FUNCTION OF ALL DEVICES AND HAVE ALTERNATE EQUIPMENT PRIOR TO USE. OLYMPUS WILL CONTINUE TO MONITOR THE FIELD PERFORMANCE OF THIS DEVICE.