LIGHT SOURCE "ENDOLED", FOR FLEXIBLE ENDOSCOPES

Additional Manufacturer Narrative

DATE OF EVENT IS UNKNOWN. ADDITIONAL INFORMATION WILL BE PROVIDED ONCE AVAILABLE. E1 - INITIAL REPORTER ESTABLISHMENT NAME:(B)(6). 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 THAT, DESPITE REPLACING THE BATTERIES, THE ENDOLED TURNS OFF DURING OPERATION DURING AN UNSPECIFIED PROCEDURE INVOLVING AN OLYMPUS BATTERY-POWERED ENDOSCOPIC LIGHT SOURCE. THE CUSTOMER SUSPECTED THAT THE ISSUE WAS CAUSED BY FLUID INVASION. THERE WAS NO PATIENT INJURY REPORTED.