EVIS EXERA III VIDEO SYSTEM CENTER

Additional Manufacturer Narrative

THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. 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 10 YEARS SINCE THE SUBJECT DEVICE WAS MANUFACTURED. BASED ON THE FACTS FOUND OUT FROM THE INVESTIGATION, IT WAS SURMISED THAT AN IMAGE BECAME INTERMITTENT DUE TO THE DAMAGED USB (UNIVERSAL SERIAL BUS) CABLE. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

Additional Manufacturer Narrative

IN SPEAKING WITH OLYMPUS TECHNICAL ASSISTANCE CENTER (TAC), THE CUSTOMER REPORTED AN INTERMITTENT BLACK IMAGE DISPLAYED ON THE PROVATION MONITOR USING THE CV-190. TAC INSTRUCTED THE CUSTOMER TO TRACE THE SDI (SERIAL DIGITAL INTERFACE) CABLE FROM THE CV-190 SDI 1 OUTPUT AND HE FOUND THAT THE USB CABLE FROM THE PROVATION INOGENI COVERTER TO THE PROVATION COMPUTER WAS DAMAGED. THE CUSTOMER WILL NEED TO REPLACE THE PROVATION USB CABLE. TO DATE, THE DEVICE HAS NOT BEEN RECEIVED FOR EVALUATION. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ANY ADDITIONAL INFORMATION IS PROVIDED BY THE USER FACILITY.

Description of Event or Problem

THE CUSTOMER REPORTED TO OLYMPUS THAT THE EVIS EXERA III VIDEO SYSTEM CENTER HAD AN INTERMITTENT BLACK IMAGE DISPLAYED ON THE PROVATION MONITOR. THE EVENT WAS FOUND BEFORE AN UNSPECIFIED PROCEDURE DURING PREPARATION FOR USE. THERE WAS NO PATIENT HARM ASSOCIATED WITH THIS EVENT.