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

Description of Event or Problem

THE CUSTOMER REPORTED THAT THE RIDGED VIDEO LAPAROSCOPE WOULD NOT CONVERT THE IMAGE TO 3D AND THE 2D IMAGE WAS BLURRY. THIS EVENT WAS DISCOVERED PRIOR TO PATIENT SEDATION AND THERE WAS NO REPORT OF PATIENT INJURY OF ADVERSE EVENT.

Additional Manufacturer Narrative

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