COLD LIGHT FOUNTAIN POWER LED 300

Additional Manufacturer Narrative

THE AFFECTED DEVICE HAS BEEN REQUESTED FOR INVESTIGATION BY THE MANUFACTURER. THE DEVICE WAS NOT YET RETURNED FOR INVESTIGATION. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).

Description of Event or Problem

IT WAS REPORTED THAT DURING SURGERY, A FROZEN IMAGE ERROR WAS TRIGGERED WHILE USING THE 30-DEGREE ENDOSCOPE. LATER IN THE PROCEDURE, THE ISSUE OCCURRED AGAIN, AND A HORIZONTAL LINE APPEARED ACROSS THE MIDDLE OF THE SCREEN AND THE LIGHT SOURCE WAS LOST. THE SURGICAL TEAM SWITCHED TO A 0-DEGREE ENDOSCOPE BECAUSE IT WAS MORE ADVANTAGEOUS TO THE PROCEDURE, WHICH WORKED WITHOUT ANY PROBLEMS. AFTER ATTEMPTING TO SWITCH BACK TO THE 30-DEGREE ENDOSCOPE, THERE WAS NO IMAGE DISPLAYED AT ALL, SO THE SURGICAL TEAM CONTINUED USING THE 0-DEGREE ENDOSCOPE. THE MONITORS WERE STILL SHOWING THAT THE 30-DEGREE ENDOSCOPE WAS CONNECTED EVEN AFTER IT HAD BEEN SWITCHED WITH THE 0-DEGREE ENDOSCOPE. THERE WAS NO PATIENT INJURY. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.