VIDEO-OPTIK "ENDOEYE 3D", 30°

Additional Manufacturer Narrative

THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO CORRECT H6 SECTION AND TO PROVIDE THE DEVICE HISTORY RECORD AND SERVICE HISTORY REVIEW INFORMATION. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

Description of Event or Problem

NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.

Additional Manufacturer Narrative

THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION AND THE REPORTED FAILURE NOT CONFIRMED. IN ADDITION, THE FOLLOWING REPORTABLE MALFUNCTIONS WERE IDENTIFIED DURING THE DEVICE EVALUATION: INCORRECT PIXEL SHIFT, DAMAGED FIBER BONDING IN THE OUTER TUBE AREA (DISTAL END) AND BROKEN CHARGED COUPLED DEVICE (R-UNIT). A ROOT CAUSE COULD NOT BE IDENTIFIED. BASED ON THE RESULTS OF THE INVESTIGATION, THE CAUSE OF THE REPORTED MALFUNCTION COMMUNICATION ERROR (E226) AND DISPLAYED A BLACK SCREEN COULD NOT BE DETERMINED. WHILE THE CAUSE OF THE ADDITIONAL MALFUNCTION INCORRECT PIXEL SHIFT, DAMAGED FIBER BONDING IN THE OUTER TUBE AREA (DISTAL END) AND BROKEN CHARGED COUPLED DEVICE (R-UNIT) WAS TRACED TO BE A COMPONENT FAILURE LIKE FRACTURE AND ELECTRICAL PROBLEM. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

Description of Event or Problem

IT WAS REPORTED THAT THE RIGID VIDEO LAPAROSCOPE HAD A COMMUNICATION ERROR (E226) AND DISPLAYED A BLACK SCREEN. THE ISSUE WAS IDENTIFIED DURING A THERAPEUTIC LAPAROSCOPIC GASTROINTESTINAL ENHANCED-VIEW TOTALLY EXTRAPERITONEAL TRANSVERSUS ABDOMINIS RELEASE PROCEDURE, WHILE THE PATIENT WAS UNDER SEDATION. THE PROCEDURE WAS COMPLETED USING THE SAME DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.