OES CHOLEDOCHO FIBERSCOPE

Additional Manufacturer Narrative

THE DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION AND THE CUSTOMER'S ALLEGATIONS WAS NOT CONFIRMED. THE EVALUATION FOUND THAT THE OBJECTIVE LENS IS SLIPPING DOWN. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

Description of Event or Problem

THE CUSTOMER REPORTED TO OLYMPUS THE OES CHOLEDOCHO FIBERSCOPE, THE CAMERA CANNOT FOCUS. THE ISSUE OCCURRED DURING AN UNKNOWN EVENT. THE PROCEDURE WAS UNKNOWN. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT.

Additional Manufacturer Narrative

THE DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION AND THE CUSTOMER'S ALLEGATIONS WAS NOT CONFIRMED. THE EVALUATION FOUND THAT THE OBJECTIVE LENS IS SLIPPING DOWN AND THAT THERE WAS A BREAKAGE OF THE EYEPIECE SECTION. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

Additional Manufacturer Narrative

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, THE ROOT CAUSE OF THE REPORTED EVENT IS UNABLE TO BE DETERMINED. THE EVENT CAN BE DETECTED BY FOLLOWING THE INSTRUCTIONS FOR USE (IFU) SECTION: INSTRUCTIONS_ PREPARATION AND INSPECTION_ INSPECTION OF THE ENDOSCOPIC SYSTEM_ INSPECTION OF THE ENDOSCOPIC IMAGE OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.