EXCELSIUS GPS
Received Jul 21, 2026 · Event occurred Jun 22, 2026
Report 3004142400-2026-00145 · MDR key 25893759
Device
Generic name
Robot, Surgical, Navigation Unit
Manufacturer
Globus Medical, Inc.Model number
6143.1001Lot number
GPS-0343
Product problems
- Human-Device Interface Problem
Patient
NA · Male
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
INVESTIGATION REVEALED THAT THERE WAS NO SYSTEM MALFUNCTION. ENGINEERING EVALUATION DID NOT FIND A SYSTEM MALFUNCTION. INVESTIGATION OF THE CASE SHOWED A SUCCESSFUL REGISTRATION WITH NO MERGE SHIFTS OR FIXATION PIN MOVEMENT. HOWEVER, FOLLOW UP INFORMATION AT THIS CASE REVEALED A BRAIN SHIFT AS THE MOST LIKELY CAUSE FOR THE "R STN" ELECTRODE MISPLACEMENT. ULTIMATELY, THIS "R STN" ELECTRODE WAS REVISED INTRA-OPERATIVELY AND THERE WERE NO REPORTED ADVERSE AFFECTS TO THE PATIENT. THE SEVERITY OBSERVED DID NOT EXCEED THE ANTICIPATED SEVERITY.THE OBSERVED OVERALL RISK LEVEL IS LOW, WHICH MATCHES THE OBSERVED ANTICIPATED RISK LEVEL; THEREFORE, THE OVERALL RISK OF THE SYSTEM HAS BEEN MAINTAINED AND THERE IS NO FURTHER INVESTIGATION REQUIRED. THE CAUSE OF THE REPORTED ISSUE CAN BE TRACED TO USER TECHNIQUE.
Description of Event or Problem
IT WAS REPORTED A RELIGHT-SIDED DBS ELECTRODE WAS IMPLANTED USING EGPS. THE RADIAL ERROR WAS 1.8MM. SURGEON DECIDED TO REMOVE THE ELECTRODE, AND PLACE A NEW ONE IN A DIFFERENT LOCATION. THE ACCURACY WAS DEEMED ACCEPTABLE.