VIDEO-OPTIK "ENDOEYE 3D", 30°

Description of Event or Problem

THE CUSTOMER REPORTED INTERMITTENTLY NOISED IMAGE DURING SERVICE INVOLVING AN OLYMPUS RIGID VIDEO LAPAROSCOPE. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

Additional Manufacturer Narrative

E1 ADDRESS: (B)(6). THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.