TELESCOPE "OES ELITE", 4 MM, 30°, HD, AUTOCLAVABLE

Description of Event or Problem

THE CUSTOMER REPORTED TO OLYMPUS, THE TELESCOPE "OES ELITE", 4 MM, 30°, HIGH DEFINITION HAD A BROKEN LENS. THE ISSUE WAS FOUND DURING PREPARATION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.

Additional Manufacturer Narrative

THE INVESTIGATION IS ONGOING. SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION OR IF ANY ADDITIONAL INFORMATION IS PROVIDED BY THE USER FACILITY.

Additional Manufacturer Narrative

THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. ADDITIONAL INFORMATION ADDED TO FIELD H6, H4. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. IT HAS BEEN OVER 3 YEARS SINCE THE SUBJECT DEVICE WAS MANUFACTURED. BASED ON THE RESULTS OF THE INVESTIGATION, THE CAUSE OF THE REPORTED ISSUES IS MOST LIKELY ATTRIBUTED TO EXCESSIVE USE. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.