EXCELSIUS GPS

Additional Manufacturer Narrative

IT WAS REPORTED THAT AN SYSTEM MALFUNCTION WAS OBSERVED DURING THE CASE. ENGINEERING EVALUATION DID FIND A SYSTEM MALFUNCTION. FOLLOW UP FROM THE GLOBUS MEDICAL FIELD SERVICE ENGINEER, SENT TO REPAIR THIS SYSTEM, REVEALED CLEARING THE MOTION LOG FILES RESOLVED THE REPORTED ISSUE. HOWEVER, THE LOSS OF MOTION DURING THIS PROCEDURE UNFORTUNATELY RESULTED IN THIS CASE BEING CANCELED. ULTIMATELY, THE PATIENT IN THIS CASE WAS WOKEN UP FROM ANESTHESIA AND THEIR PROCEDURE WAS RESCHEDULED. THE SEVERITY OBSERVED DID NOT EXCEED THE ANTICIPATED SEVERITY. THE OBSERVED OVERALL RISK LEVEL IS 6 OR 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.

Description of Event or Problem

IT WAS REPORTED THAT IN A EXCELSIUSGPS SURGERY, THE ARM LOST MOTION COMPLETELY AFTER REACHABILITY CHECK. THE REACHABILITY CHECK WAS SMOOTH WITHOUT ANY PROBLEMS. THE CSR WENT TO EXTEND ARM FOR DRAPING AND ARM WOULD NOT MOVE WHEN PRESSING THE CONTROL PANEL BUTTONS. NO WARNINGS APPEARED. THE CSR ATTEMPTED TO MOVE THE ARM WITH THE SURGEON'S BRACELET, HOWEVER ARM STILL WOULD NOT MOVE. NO WARNING APPEARED. THE CSR DID THE FOLLOWING TROUBLESHOOTING: MULTIPLE SOFTWARE RESETS, MULTIPLE HARD SHUTDOWNS AND REBOOTS, MULTIPLE ATTEMPTS TO RE-HOME THE ARM AND RECEIVED A "ROBOT ARM HOMING FAILED" WITH INFORMATION RING TURNING RED. THE MOTION OF ARM WAS NEVER REGAINED, ARM WAS NOT ABLE TO BE DOCKED EITHER. THE SURGEON HAD TO CANCEL THE CASE DUE TO ROBOT BEING UNUSABLE AFTER PATIENT WAS INTUBATED.