VIDEO-OPTIK "ENDOEYE 3D", 30°

Additional Manufacturer Narrative

THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION AND THE REPORTED FAILURE WAS CONFIRMED. IN ADDITION, THE FOLLOWING REPORTABLE MALFUNCTIONS WERE IDENTIFIED DURING THE DEVICE EVALUATION: NO IMAGE IS DISPLAYED. LLK PLUG OF THE VIDEO CABLE SECTION CONTAINS FOREIGN MATERIAL. A ROOT CAUSE COULD NOT BE IDENTIFIED. HOWEVER, BASED ON THE RESULTS OF THE INVESTIGATION, THE MOST PROBABLE CAUSE OF THE REPORTED MALFUNCTION WAS TRACED TO VIDEO CABLE WAS BROKEN. 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 E216 ERROR(SCOPE COMMUNICATION ERROR CODE). THE ISSUE WAS FOUND DURING A SET UP. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

Additional Manufacturer Narrative

THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF THE FINAL INVESTIGATION. UPDATED FIELDS: H2, H6, H11. THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION AND THE REPORTED FAILURE WAS CONFIRMED. IN ADDITION, THE FOLLOWING REPORTABLE MALFUNCTIONS WERE IDENTIFIED DURING THE DEVICE EVALUATION: NO IMAGE IS DISPLAYED, AND FOREIGN MATERIAL ON THE LASER LIGHT CABLE OF THE VIDEO CABLE SECTION. A ROOT CAUSE COULD NOT BE IDENTIFIED. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS PRESUMED THAT THE REPORTED EVENT OCCURRED AND NO IMAGE DUE TO BROKEN VIDEO CABLE AND THE DEFINITIVE CAUSE FOR ADDITIONAL REPORTABLE FINDING OF FOREIGN MATERIAL IN THE LASER LIGHT CABLE OF THE VIDEO CABLE SECTION COULD NOT BE DETERMINED. 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