VIDEO ADAPTER

Additional Manufacturer Narrative

THE DEVICE WAS RETURNED, AND AN INITIAL EVALUATION WAS CONDUCTED BY OLYMPUS; HOWEVER, INVESTIGATION IS ONGOING. DURING THE INITIAL EVALUATION, AS NOTED, THE UNIT HAD UNDERGONE INSUFFICIENT REPROCESSING DUE TO BIOLOGICAL MATERIAL HAVING BEEN FOUND IN THE AIR/WATER LEAKAGE AREA. ADDITIONALLY, PHYSICAL DAMAGE WAS NOTED ON THE SUBJECT DEVICE, AS WELL AS A IMAGING FOCUSING PROBLEM - CONFIRMING THE USER'S REPORT. IF ADDITIONAL INFORMATION BECOMES AVAILABLE FOLLOWING THE DEVICE EVALUATION, A SUPPLEMENTAL REPORT WILL BE FILED.

Description of Event or Problem

THE CUSTOMER ORIGINALLY RETURNED HER OLYMPUS VIDEO ADAPTER DUE TO A FOCUSING ISSUE. DURING THE DEVICE EVALUATION, IT WAS DISCOVERED THAT THE SUBJECT DEVICE HAD UNDERGONE INSUFFICIENT REPROCESSING AS BIOLOGICAL FOREIGN MATERIAL WAS FOUND IN THE AIR/WATER WAY. THIS REPORT IS BEING SUBMITTED TO CAPTURE THE INSUFFICIENT REPROCESSING FOUND DURING THE DEVICE EVALUATION.

Additional Manufacturer Narrative

THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. THE INVESTIGATION CONFIRMED THE REPORTED IMAGE THAT WAS OUT OF FOCUS. WATER INVASION AND CORROSION WERE NOTED INSIDE THE DEVICE. THE CAUSE OF THE WATER INVASION WAS UNKNOWN. A REVIEW OF THE DEVICE HISTORY RECORD WAS NOT PERFORMED BECAUSE THE LOT NUMBER OF THE SUBJECT DEVICE WAS UNKNOWN. THE INVESTIGATION DID NOT ESTABLISH A ROOT CAUSE FOR THE REPORTED IMAGE PROBLEM. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.