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

Description of Event or Problem

IT WAS REPORTED THAT DURING A THERAPEUTIC RETROPERITONEAL SUBPERITONEAL NEPHROURETERECTOMY PROCEDURE, THE RIGID VIDEO LAPAROSCOPE DID NOT COME INTO FOCUS EVEN AT THE SPECIFIED FOCAL LENGTH. THE ISSUE OCCURRED DURING SEDATION WHILE THE DEVICE WAS INSIDE THE PATIENT, AND THE PROCEDURE WAS COMPLETED USING AN OLYMPUS BACKUP DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

Additional Manufacturer Narrative

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