VIDEO TELESCOPE "ENDOEYE 3D", 10 MM, 0°

Additional Manufacturer Narrative

THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

Description of Event or Problem

THE CUSTOMER REPORTED A STATIC IMAGE, A FOUR PART GRAYSCALE IMAGE, AND THE ABSENCE OF A NORMAL IMAGE DISPLAY IN AN OLYMPUS RIGID VIDEO LAPAROSCOPE. THERE WAS NO PATIENT INJURY REPORTED.