VIDEO-OPTIK "ENDOEYE 3D", 30°

Additional Manufacturer Narrative

DATE OF EVENT IS UNKNOWN. ADDITIONAL INFORMATION WILL BE PROVIDED IF AVAILABLE. THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION. A ROOT CAUSE COULD NOT BE IDENTIFIED. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY R-UNIT (CHARGED COUPLED DEVICE) IS BROKEN AND THEREFORE THE RESOLUTION IS INADEQUATE, DEFECTS IN THE 3D IMAGE ARE CAUSED DUE TO BROKEN VIDEO CABLE. SCRATCHES ON THE OUTER TUBE RESULTED IN SHARP EDGES. HOWEVER, THE MOST PROBABLE CAUSE OF FOREIGN MATERIAL COULD NOT BE ESTABLISHED. 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 RETURNED THE RIGID VIDEO LAPAROSCOPE TO THE SERVICE CENTER FOR EVALUATION RELATED TO A SEPARATE ISSUE. DURING TESTING, THE SERVICE TECHNICIAN IDENTIFIED THE DEVICE HAD BROKEN CHARGED COUPLED DEVICE (R-UNIT), IMAGE HAD DEFECTS OR WAS NOT DISPLAYED AND THE RESOLUTION WAS INADEQUATE, FOREIGN MATERIAL IN COVER GLASS OF THE INSERTION SECTION AND SHARP EDGES AT THE OUTER TUBE. THERE WAS NO PATIENT INVOLVEMENT.