TELESCOPE "OES ELITE", 4 MM, 12°, HD, AUTOCLAVABLE

Additional Manufacturer Narrative

THE DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION AND THE EVALUATION FOUND A LOOSE COLOR RING AND A DISPLACES LENS. THE INVESTIGATION IS ONGOING AND FOLLOW UP WITH THE USER FACILITY IS CURRENTLY BEING PERFORMED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION OR IF ANY ADDITIONAL INFORMATION IS PROVIDED BY THE USER FACILITY.

Description of Event or Problem

THE CUSTOMER REPORTED TO OLYMPUS, THE TELESCOPE "OES ELITE", 4 MM, 12°, HIGH DEFINITION HAD AN OFFSET CENTER AND A LOOSE COLOR RING. THERE WERE NO REPORTS OF PATIENT HARM. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE LOOSE COLOR RING REPORTED BY THE CUSTOMER.

Additional Manufacturer Narrative

THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. CORRECTED FIELDS: G2 (HEALTH PROFESSIONAL SHOULD BE REMOVED FROM THE INITIAL MEDWATCH). A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. IT HAS BEEN OVER 2 YEARS SINCE THE SUBJECT DEVICE WAS MANUFACTURED. THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION, AND THE CUSTOMER'S REPORTABLE MALFUNCTION OF THE LOOSE COLOR RING WAS CONFIRMED. BASED ON THE RESULTS OF THE INVESTIGATION, THE SUGGESTED EVENT WAS LIKELY DUE TO EXCESSIVE FORCE BY THE USER. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.