OPERON
Received Aug 15, 2012 · Event occurred Jul 9, 2012
Report 8010153-2012-00004 · MDR key 2710960
Device
Product problems
- Unintended Movement
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
DURING A SURGICAL PROCEDURE WITH A PT ON THE TABLE, AND UTILIZING A DAVINCI ROBOT, THE TABLE WAS REPORTED TO HAVE MOVED FROM A TRENDELENBURG POSITION TO A LEVEL POSITION WITHOUT ANY ACTIVATION OF THE LEVEL BUTTON ON THE HAND CONTROL. NO INJURY WAS REPORTED.
Additional Manufacturer Narrative
THE TABLE WAS EVALUATED BY A BERCHTOLD FIELD SERVICE REP ON (B)(4) 2012. THE PROBLEM WAS NOT DUPLICATED. THE HAND CONTROL HAD SOME DAMAGE, AND THE HEIGHT SENSOR REQUIRED REPLACEMENT, BUT NEITHER OF THESE COULD BE DIRECTLY LINKED TO THE MALFUNCTION. BOTH THE HEIGHT SENSOR AND THE HAND CONTROL WERE REPLACED AND THE TABLE WAS PLACED BACK INTO SERVICE.