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

Additional Manufacturer Narrative

THE DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION AND THE EVALUATION FOUND THE INTERNAL LENS WAS DAMAGED, AND THE OUTER TUBE WAS BENT. THE DAMAGED EYEPIECE COULD NOT BE CONFIRMED. THE INVESTIGATION IS ONGOING. 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 A CRACKED EYEPIECE CUP AND DISPLAYED A SHADOWY IMAGE. THE ISSUE WAS FOUND DURING PREPARATION FOR USE FOR A THERAPEUTIC, HYSTEROSCOPY PROCEDURE. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

Additional Manufacturer Narrative

THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. CORRECTED FIELDS: G2(UNSELECT HEALTH PROFESSIONAL). ADDITIONAL INFORMATION ADDED TO FIELD H6. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. IT HAS BEEN OVER 01 YEARS SINCE THE SUBJECT DEVICE WAS MANUFACTURED. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY THAT DUE TO EXCESSIVE FORCE BY THE USER THE MALFUNCTION OCCURRED. HOWEVER, A DEFINITE ROOT CAUSE THAT LED TO THE MALFUNCTION COULD NOT BE IDENTIFIED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.