988 CAMERA CONTROL UNIT
Received May 16, 2011 · Event occurred Apr 15, 2011
Report 2936485-2011-00333 · MDR key 2097634
Device
Product problems
- No Display/Image
- Loss of Power
Patient
UNK
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED.
Description of Event or Problem
IT WAS REPORTED THAT CONSOLE SHUT DOWN DURING THE SURGERY. IT WAS FURTHER REPORTED THAT IN THE BEGINNING, THE CONSOLE WAS FUNCTIONING AND MONITORED. THE DOCTOR THEN NOTICED THE MONITOR HAD NO IMAGE (BLACK OUT) WHEN HE TOOK THE SCOPE OUT FROM THE SHEATH AND INSERTED IT AGAIN, AS HE NEEDED TO WIPE IT AS IT WAS MOISTURED AFTER INSERTION OF THE TROCAL WATCHING THE MONITOR. ALL THE DEVICES WERE CHECKED AND FOUND THAT THE CONSOLE SHUT DOWN (ALL THE LED/LAMPS/INDICATORS ON THE FRONT PANEL WERE BLACKED OUT). THE CALLED THE SALES REP AND TECHNICAL CENTER FOR A BACKUP DEVICE BUT IT WOULD TAKE MORE THAN 1 HOUR, SO THE DOCTOR EXPLAINED IT TO THE PATIENT'S FAMILY AND PERFORMED AN OPEN SURGERY.