VIDEO-OPTIK "ENDOEYE 3D", 30°

Additional Manufacturer Narrative

THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION, AND THE REPORTED FAILURE WAS NOT CONFIRMED. IN ADDITION, THE FOLLOWING REPORTABLE MALFUNCTIONS WERE IDENTIFIED DURING THE DEVICE EVALUATION: CHARGED COUPLED DEVICE WAS BROKEN, THE LIGHT TRANSMISSION WAS LOST OR TOO LOW. 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, A DEFINITIVE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED. ADDITIONALLY, THE MOST LIKELY CAUSE OF THE MALFUNCTION IDENTIFIED DURING DEVICE EVALUATION WAS ATTRIBUTED TO COMPONENT FAILURE. HOWEVER, THE MOST PROBABLE CAUSE OF THE ISSUE, WHERE LIGHT TRANSMISSION WAS LOST OR SIGNIFICANTLY REDUCED, WAS TRACED TO A BREAK IN THE LIGHT GUIDE BUNDLE OF THE VIDEO CABLE SECTION. 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

THE CUSTOMER REPORTED IMAGE PROBLEMS DURING LAPAROSCOPY PROCEDURE INVOLVING AN OLYMPUS RIGID VIDEO LAPAROSCOPE WHILE THE PATIENT WAS UNDER SEDATION AND THE DEVICE WAS INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. THERE WAS NO PATIENT INJURY REPORTED.