EVIS EXERA III XENON LIGHT SOURCE

Additional Manufacturer Narrative

OLYMPUS TECHNICAL ASSISTANCE CENTER (TAC) SUPPORT SPOKE TO THE CUSTOMER TO TROUBLESHOOT THE DEVICE. THE CUSTOMER MENTIONED THAT THE ISSUE OCCURS WITH THE 180 AND 190 SCOPES. TAC ASKED THE CUSTOMER TO EXCHANGE THE CV-190 TO HELP TROUBLESHOOT BUT THE CUSTOMER DECLINED TROUBLESHOOTING ASSISTANCE. THE CUSTOMER INITIALLY REQUESTED FOR A FIELD SERVICE ENGINEER (FSE) TO COME ONSITE BUT LATER CALLED TO CANCEL. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. THE INVESTIGATION IS ONGOING; THEREFORE, THE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED AT THIS TIME, HOWEVER, IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY.

Description of Event or Problem

THE CUSTOMER REPORTED THE EVIS EXERA III XENON LIGHT SOURCE DISPLAY A B30 AND AN E216 ERROR. THE EVENT OCCURRED DURING PREPARATION FOR USE, PRIOR TO DIAGNOSTIC PROCEDURE. THERE WAS NO PATIENT HARM OR USER INJURY REPORTED DUE TO THE EVENT. THIS REPORT IS BEING SUBMITTED FOR THE B30 ERROR.

Additional Manufacturer Narrative

THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE APPROVED 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, AND SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION, THE DEFINITIVE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.