VIDEO-OPTIK "ENDOEYE 3D", 30°

Additional Manufacturer Narrative

THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION. THE DATE OF EVENT IS UNKNOWN. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF PROVIDED BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY THE FOLLOWING LED TO THE MALFUNCTION IT IS CAUSE TRACED TO STRESS. 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 OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID VIDEO LAPARASCOPE EXHIBITED IN THE OUTER TUBE AND THEREFORE HAS SHARP EDGES. THERE WAS NO PATIENT INVOLVEMENT.