VELYS 451611001Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 10705034646008), received between Aug 5, 2025 and Sep 29, 2026 — classified as 2 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Positioning Failure” (12 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Positioning Failure; Use of Device Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50931541 ↗
• MalfunctionSep 16, 2026Mechanical Problem; Intermittent Loss of Power

  It was reported that there was an excessive amount of joints clicking through out the case that resulted in temporary arm delays. Robot on Patient right. There were no reports of injuries, medical intervention or prolonged hospitalization. No further information was provided

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50791620 ↗
• MalfunctionAug 17, 2026Positioning Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50274134 ↗
• MalfunctionMar 12, 2026Positioning Failure

  IT WAS REPORTED THAT VELYS NAVIGATION STATION, VELYS ROBOTIC-ASSIST STATION, VELYS CAMERA STATION, AND VELYS SPINE ARRAY BASE SET WERE INVOLVED IN A REPORTED EVENT DURING A SPINAL PROCEDURE. THE ISSUE WAS DESCRIBED AS TWO SCREWS BEING PLACED 5MM OFF FROM THE PLANNED POSITION, WITH THE ROBOTIC SYSTEM POSITIONED ON THE PATIENT'S RIGHT SIDE. TROUBLESHOOTING INCLUDED CONDUCTING A SECOND SPIN BEFORE REMOVING AND REPLACING THE SCREWS. THERE WAS PATIENT INVOLVEMENT, BUT NO INJURIES, MEDICAL INTERVENTION, OR PROLONGED HOSPITALIZATION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24586201 ↗
• MalfunctionFeb 20, 2026Break; Complete Loss of Power

  IT WAS REPORTED THE ROBOT STATION'S TOUCHSCREEN POWER CABLE HAS EXPOSED WIRES AND ROBOT STATION WILL NOT POWER ON. CASE WAS COMPLETED AS NAV ONLY. NO FURTHER INFORMATION IS AVAILABLE. FACILITY HAS MULTIPLE NAV AND CAMERA STATIONS AND 1 ROBOT STATION. UNKNOWN WHICH NAV AND CAMERA STATIONS WERE BEING USED DURING THE CASE. THERE WERE NO TREATMENT DELAYS OR CANCELLATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24401503 ↗
• MalfunctionFeb 17, 2026Positioning Failure

  IT WAS REPORTED DURING A L4- S1 ROBOTIC ENABLED FUSION USING VIPER PRIME THE RIGHT L4 ANTICIPATED THAT SCREW WAS OFF DUE TO FEEDBACK FROM ROBOT. THIS WAS PATIENTS RIGHT SIDE. XRAY CONFIRMED THE SCREW WAS OFF. TO RECONCILE, THE SCREW WAS PLACED WITH FREEHAND NAVIGATION INTO THE CORRECT POSITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24370065 ↗
• MalfunctionFeb 6, 2026Positioning Failure

  IT WAS REPORTED THAT VELYS NAVIGATION STATION, VELYS CAMERA STATION, VELYS ROBOTIC-ASSIST STATION, AND UNK - SCREWS: VIPER PRIME WERE INVOLVED IN A REPORTED EVENT DURING A SPINAL FUSION PROCEDURE. THE ISSUE OCCURRED INTRA-OPERATIVELY DURING SCREW PLACEMENT USING ROBOTIC ASSISTANCE, WHERE FEEDBACK FROM THE MONITOR INDICATED LOSS OF ADAPTIVE TRACKING, AS SHOWN BY A RED SCREEN AND RED SCREW. THE SCREW APPEARED OFF COMPARED TO THE PLANNED TRAJECTORY, BUT AFTER MINOR TROUBLESHOOTING, INCLUDING REMOVING AND RESENDING TRAJECTORIES, THE SCREW FOLLOWED THE SAME PATH AND WAS ULTIMATELY PLACED ACCURATELY ACCORDING TO PLAN, AS CONFIRMED BY FINAL IMAGING. THE EVENT RESULTED IN A MINOR DELAY OF APPROXIMATELY THREE MINUTES, WITH NO REPORTED PATIENT INJURY, MEDICAL INTERVENTION, OR PROLONGED HOSPITALIZATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24276803 ↗
• MalfunctionJan 23, 2026Use of Device Problem

  IT WAS REPORTED DURING THORACIC PERCUTANEOUS PSF T8-T12 SURGERY, LOSS OF CAMERA CONNECTION OCCURRED. CAMERA CORD WAS PLUGGED IN THE ENTIRE TIME. RECEIVED ERROR: CONNECTION WAS LOST AND THEN CONNECTION REGAINED. THIS HAPPENED TWICE DURING THE SURGERY. COMPANY REPRESENTATIVE STATED THE ARM OF THE CAMERA NEEDS AN EXTRA JOINT TO VISUALIZE THE ARRAYS. ROBOT NEVER CAME INTO THE FIELD BECAUSE THEY WERE UNABLE TO REGISTER THE PATIENT DUE TO PATIENT'S HIGH BMI. COULD NOT CAPTURE THE PHANTOM ARRAY IN THE LATERAL SCOUT. WHAT STEP WERE THEY ON WHEN THIS ISSUE OCCURRED? REGISTERING ARRAYS WAS THIS A ROBOTIC OR NAVIGATION ONLY PROCEDURE? ROBOTIC, ROBOT WAS POSITIONED ON THE PATIENT'S RIGHT SIDE. TROUBLESHOOTING. UNKNOWN PATIENT INVOLVEMENT? YES WERE THERE REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION? NO ARE PATIENT TREATMENTS DELAYED OR CANCELED? YES, REP STATED THE SURGERY WAS ABORTED - NO OTHER SURGERIES ARE SCHEDULED. NEXT DAY OF SURGERY: NONE AT THIS TIME REP REQUESTED FOR THIS TO BE ESCALATED. ALL INFORMATION HAS BEEN DISCLOSED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24163308 ↗
• MalfunctionJan 21, 2026Positioning Failure

  PROBLEM REPORT: CASE 1 OF 2. IT WAS REPORTED THERE WAS AN ERROR ON PLACING THE VIPER PRIME SCREW VIA ROBOTIC GUIDANCE. THEY RECEIVED FEEDBACK FROM THE MONITOR THAT THEY LOSED ADAPTIVE TRACKING AS INDICATED BY A RED SCREEN AND RED SCREW - AND THE SCREW APPEARS OFF COMPARED TO PLAN. HOWEVER, ON MINOR TROUBLESHOOTING, WHICH ENTAILED REMOVING THE SCREW AND RESENDING TRAJECTORIES THE SCREW SEEMED TO FOLLOW THE SAME PATH AND ON FINAL XRAY SHOWED IT WAS ACCURATELY PLACED ACCORDING TO PLAN. WHAT TYPE OF SURGERY: MIS POSTERIOR FUSION. WHAT STEP WERE THEY ON WHEN THIS ISSUE OCCURRED? SCREW PLACEMENT. WAS THIS A ROBOTIC OR NAVIGATION ONLY PROCEDURE? ROBOTIC ASSIST. TROUBLESHOOTING: LISTED ABOVE - REQUESTED FSE SUPPORT FOR THE CASE LOG TO BE REVIEWED. PATIENT INVOLVEMENT? YES. WERE THERE REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION? NO - MINOR 3 MIN DELAY. NEXT DAY OF SURGERY: (B)(6) 2026. ALL INFORMATION HAS BEEN DISCLOSED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24130062 ↗
• MalfunctionDec 30, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT DURING A T4 TO L1 POSTERIOR SPINAL FUSION PROCEDURE, DURING SCREW THE SURGEON DEEMED THAT THE PHANTOM WAS INACCURATE WHEN T7 AND T8 ON THE LEFT SIDE WERE LATERAL TO PLAN. A SECOND SPIN WAS COMPLETED AND WHEN THEY PLACED THE REST OF THE SCREWS IN THE SEGMENT, 4 OF THE SCREWS WERE CONSIDERED INACCURATE TO PLAN: T6 WAS LATERAL ON LEFT SIDE, T5 ON THE RIGHT SIDE WAS DEEMED MEDIAL, T7 ON RIGHT SIDE WAS DEEMED MEDIAL AND T8 ON THE RIGHT SIDE WAS DEEMED MEDIAL. SOME SCREWS WERE REPLACED WITH FREE HAND NAVIGATION AND OTHERS WERE NOT IN THE SPIN WERE COMPLETED FREE HAND WITHOUT NAVIGATION. ROBOT WAS ON THE PATIENT'S RIGHT SIDE. THERE WAS PATIENT INVOLVEMENT, BUT NO INJURIES, MEDICAL INTERVENTION, OR PROLONGED HOSPITALIZATION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23923484 ↗
• MalfunctionDec 29, 2025Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THERE WAS A PROBLEM REPORT: REP REPORTED AN ISSUE ON THE BILATERAL L5 ROBOT TRAJECTORIES OF THE ROBOT'S ARM PASS INTERFERING WITH THE PATIENT. EVENT OCCURRED DURING A SINGLE POSITION LATERAL FUSION. IT OCCURRED DURING A ROBOT NAVIGATION. PATIENT WAS IN A LATERAL POSITION WITH THEIR LEFT SIDE UP. ROBOT CAME IN FROM THE PATIENT'S BACK TOWARDS THE HEAD. TROUBLESHOOTING RESULTED IN A 5-8 MIN DELAY WITH MULTIPLE TROUBLE SHOOTING EFFORTS WITH THE FINAL SOLUTION NOT BEING IDEAL. NEXT DAY OF SURGERY: (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23907893 ↗
• MalfunctionDec 22, 2025Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT PATIENT UNDERWENT A L4-S1 MIS TLIF PROCEDURE. ON THE LAST TRAJECTORY, L4 LEFT (SCREW PLACEMENT), THE DOCTOR WENT TO DISENGAGE THE DRIVER. THEY NOTICED FLICKERING OF THE PATIENT ARRAY AND THE HANDGRIP AND THE ROBOTIC ARM STARTED MOVING TOWARD THE PATIENT, LOCKING THE DRIVER ENGAGED IN THE PATIENT. THEY TOOK THEIR FOOT OFF THE FOOTSWITCH, MANUALLY MANIPULATED THE ROBOTIC ARM AWAY FROM THE PATIENT AND REMOVED THE DRIVER. THE ARRAYS HAVE BEEN DISCARDED. THERE WAS NO PATIENT CONSEQUENCE AND NO TREATMENT DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23871188 ↗
• MalfunctionDec 11, 2025Positioning Failure; Use of Device Problem; Positioning Failure; Use of Device Problem

  DURING THE PROCEDURE, THE T9 SCREW INADVERTENTLY ENTERED THE T8/T9 DISC SPACE. AN EXCESSIVE FORCE WARNING APPEARED ON THE SCREEN DURING THE CASE. AFTER DECOMPRESSION, THE T9 SCREW WAS REMOVED AND CORRECTLY REPOSITIONED USING VELYS NAVIGATION ONLY. THERE WAS NO PATIENT HARM. OBSERVED FACTORS DURING THE CASE THE FOLLOWING CONDITIONS WERE NOTED ¿ THE PA WAS POSITIONED ON THE PATIENT¿S RIGHT SIDE, AND THE CAMERA WAS ALSO ON THE PATIENT¿S RIGHT AT THE FOOT OF THE BED. THE PA¿S SHOULDER OBSTRUCTED THE CAMERA¿S LINE OF SIGHT. ¿ THERE WAS LATERAL PRESSURE FROM BOTH THE RETRACTOR AND THE SOFT TISSUE INCISION. ¿ THE TP WAS OBSTRUCTING THE PATHWAY AND WAS BUMPED DURING THE PROCEDURE. SURGICAL PLAN. THE SURGERY WAS INITIALLY PLANNED AS A FULL T6¿T9 PROCEDURE; HOWEVER, THE INTENT WAS TO ADDRESS T6, T9, AND RIGHT T8 ONLY. T7 AND LEFT T8 REQUIRED A TRANSPEDICULAR APPROACH TO DECOMPRESS A CENTRALLY LOCATED HERNIATION. THE CASE WAS PERFORMED AS AN OPEN PROCEDURE USING VIPER PRIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23779415 ↗
• MalfunctionOct 28, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT THE L2-L4 MIS PEDICLE SCREW CASE. THE DOCTOR STARTED L2-L3 ON THE RIGHT SIDE. HE STATED THAT HE FELT THAT THE KNIFE JIG WAS NOT HELPING HIM GET THE PROPER TRAJECTORY SO HE TRANSITIONED FROM USING THE ROBOT TO FREEHAND PLACEMENT FOR THE INCISION FOR L4 RIGHT. HE CONTINUED FREEHAND PLACEMENT ON L2 LEFT TO L4 LEFT. THE FINAL X-RAY FOUND AND AN O-ARM SPIN CONFIRMED THAT THE LEFT L2 SCREW WAS BOTH HIGH AND LATERAL COMPARED TO PLAN. THEY COMPLETED ANOTHER SPIN, REPLANNED THE LEFT L2 WITH THE NAVIGATION AND ROBOT AND THE REVISED PLACEMENT WAS ACCEPTABLE TO THE SURGEON. IT WAS APPROXIMATELY A 60 MINUTES DELAY. ALL INFORMATION HAS BEEN DISCLOSED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 23406346 ↗
• MalfunctionOct 23, 2025Unintended System Motion; Use of Device Problem; Malposition of Device; Unintended System Motion; Use of Device Problem; Malposition of Device

  ADDITIONAL INFORMATION RECEIVED: I¿D ESTIMATE A 5MM DEVIATION FROM PEDICLE CENTER. THE SCREWS WERE RE-INSTRUMENTED BY THE SURGEON FOR GREATER FIXATION SO THAT THE TOP OF THE CONSTRUCT WOULD BE LESS LIKELY TO PULL OUT. I DON¿T RECALL BUT TO MY UNDERSTANDING THE SYSTEM WAS ACCURATE AT THIS SEGMENT. THE SCREW DISPLACEMENT WASN¿T A PRODUCT OF REGISTRATION INACCURACY LIKE THE LUMBAR SEGMENT WAS, THE PROBLEM WITH THESE PARTICULAR DEVIATIONS IS THAT THE SURGEONS ARE USED TO OPERATING WITH VIEWS THAT ARE ANATOMICALLY CORRECT FROM AN AXIAL, SAGITTAL, AND CORONAL STANDPOINT. BECAUSE OUR SOFTWARE IS UNABLE TO DE-ROTATE THE ANATOMY IN THE NAVIGATION DISPLAY, THE SURGEONS ARE FORCED TO OPERATE ON THIS SCOLIOTIC ANATOMY IN A CONFUSING ORIENTATION. THE NAVIGATION STILL ACCURATELY ASSISTS THEM, THE ANATOMY THAT THEY¿RE LOOKING AT ON THE NAVIGATION SCREEN IS JUST POSITIONED IN A WAY THAT IS MUCH HARDER TO READ. THE ISSUE IS TECHNICALLY USER ERROR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23368118 ↗
• InjuryOct 21, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A L4-L5 A TLIF PROCEDURE WITH MIS PRIME SCREWS ON FIRST SIDE AND FACET SCREWS ON THE OPPOSITE SIDE. THE SURGEON PUT THE TWO PEDICLE SCREWS ON ONE SIDE FIRST, THEN THE CAGE AND LASTLY THE SET SCREW ON THE OTHER SIDE. SURGEON DID THE VIPER PRIME WITHOUT ISSUE AND COMPLETED THE SPIN, COMPLETED REGISTRATION. FOLLOWING REGISTRATION, SYSTEM REQUESTED ANATOMY CHECK ¿ SURGEON PERFORMED ANATOMY CHECK AND STATED IT WAS ACCEPTABLE. WHEN THEY REACHED THE POINT WHERE THEY WERE READY TO SEND THE ROBOT ARM TO THE TRAJECTORY ¿ WARNING RECEIVED¿ PATIENT TRACKER ANGLE AND L4 SCREW WOULD BE A COLLISION. PATIENT ARRAY WAS LOCATED ON THE PSIS RIGHT SIDE. THEY ADJUSTED THE ANGLE OF THE SCREWS MORE LATERALLY AND AT THIS POINT THE DOCTOR BUMPED THE PATIENT ARRAY. THEY WENT TO THE FIRST TRAJECTORY, PUT THE CORE DOWN, BROUGHT IN THE 5MM ACORN BIT, REP RECOMMENDED MAKING A KNOCKING POINT. THE DOCTOR WENT DOWN AND THE PATIENT MOVED, DESCRIBED AS THEY BUCKED LIKE THEY WERE IN PAIN. THE DOCTOR PUT THE SCREW IN AND IT WAS TESTING AT A 7. THEY BROUGHT IN THE X-RAY AND FOUND THE SCREW WAS MEDIALIZED. THEY CHANGED THE TRAJECTORY OF THE SCREW AND IT WAS TESTING AT AN 8. THE

  Patient problems: Nerve Damage

  MAUDE report 23353500 ↗
• MalfunctionOct 15, 2025Break; Unintended System Motion; Break; Unintended System Motion

  PROBLEM REPORTED: T2-L3 OPEN FUSION PROCEDURE. TWO ISSUES IDENTIFIED DURING THE CASE: 1. THERE ARE SMALL CRACKS ON THE LEDS ON THE PORTION OF THE HANDGRIP CLOSEST TO THE TOOL INTERFACE. 2. THE CAMERA DOESN'T HAVE ENOUGH ARTICULATION SO IT MAKES IT DIFFICULT TO NAVIGATE DURING SURGERY. WHEN PLACING THE THORACIC PEDICLE, THE ROBOT WAS GOING TO HIT THE PATIENT¿S HEAD. SURGEON INTERVENED AND STOPPED THE ROBOT. SURGEON ATTEMPTED TO MANUALLY MANIPULATE THE ROBOT ARM OUT OF THE WAY BUT IT WOULD RETURN BACK TO THE ORIGINAL SPOT NEAR THE PATIENT. CASE WAS COMPLETED NAV ONLY. WHAT STEP WERE THEY ON WHEN THIS ISSUE OCCURRED? THROUGHOUT. WAS THIS A ROBOTIC OR NAVIGATION ONLY PROCEDURE? ROBOTIC. TROUBLESHOOTING: NONE. PATIENT INVOLVEMENT? YES. WERE THERE REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION? NO. ARE PATIENT TREATMENTS DELAYED OR CANCELLED? NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23294186 ↗
• MalfunctionAug 21, 2025Unintended System Motion; Unintended System Motion

  THE CUSTOMER REPORTED THAT THIS WAS A SPINE ROBOTIC CASE FOR L1-S2. DURING THE PROCEDURE THEY MOVED TO S2 THE TOOL HOLDER WAS VIOLATING THE SAFETY BOX OF THE PHANTOM. IT THEN VIOLATED SAFETY BOX DURING EVERY TRAJECTORY. WHEN SENDING IT TO NEXT TRAJECTORY THE ROBOT COLLIDED WITH THE PATIENT. TROUBLESHOOTING INCLUDED: SHUTDOWN THE ROBOT STATION AND RESTARTED. COMPLETED BRAKE TEST BEFORE PROCEEDING. THEY WERE ABLE TO COMPLETE THE CASE HOWEVER, THE SYSTEM CONTINUED TO VIOLATE THE SAFETY BOX. SETTING UP CT IMAGE BEFORE HAND THERE WERE NO ISSUES THEY ATTACHED THE PATIENT ARRAY TO L1 AND THE PHANTOM ARRAY OVER THE OPERATION AREA. PATIENT WAS AVERAGE SIZE. ROBOT COLLIDED WITH PATIENT NEAR THE T12 AREA (RIB) LEFT SIDE OF THE PATIENT. THERE WAS A SURGICAL DELAY OF 10-15 MINUTES. THE PATIENT HAS POTENTIAL BRUISING AS THE ROBOT COLLIDED WITH THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22861399 ↗
• MalfunctionAug 15, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT DURING SCREW PLACEMENT IN A SPINAL PROCEDURE, THE L4 RIGHT SCREW WAS SLIGHTLY LATERAL FROM PLAN DUE TO SCREWDRIVER HITTING THE RETRACTOR AND DUE TO SCREW RELEASE MODE. SCREW POSITION WAS CONFIRMED BY O-ARM SPIN. 3D IMAGING WAS USED. JUST ONE PORTION OF THE SCREW TRAJECTORY WAS LATERAL. THE SCREWDRIVER COLLIDED WITH THE END OF THE SELF RETAINING RETRACTOR, WHICH ALTERED THE TRAJECTORY. SCREW RELEASE/ACTIE MODE WAS ATTEMPTING TO REDIRECT SCREW BACK TO ORIGINAL POSITION MID-INSERTION DUE TO DEFLECTION BY RETRACTOR. USER REMOVED SCREW AND PLACED WITH FREE-HAND NAVIGATION. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THERE WAS A MINIMAL DELAY DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22817913 ↗
• InjuryAug 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING A SPINAL PROCEDURE CASE, THE PATIENT NOW HAS AN INFECTION AND THE SURGEON FEELS THAT IT DUE TO THE SYSTEM BEING NEAR A HIGH TRAFFIC AREA, AND THAT MAY HAVE CAUSED THE INFECTION. IT WAS NOTED THAT THE SYSTEM WAS STERILELY DRAPED. IT WAS THOUGHT THAT THE WHITE STICKER AT THE END OF THE DRAPE WHEN PULLED IS OF CONCERN, SINCE IT REVEALS AN UNSTERILE CONNECTION POINT. IT OPENS THE SCRUB NURSE TO CONTAMINATING THEIR GLOVES AS THEY PUT THE ENDPLATE ON THE ROBOT. MOST SCRUB NURSES HAVE CHANGED THEIR GLOVES AFTER ASSEMBLY. THE ROBOT WAS IN THE CORNER OF THE OPERATING ROOM TO MAKE WAY FOR THE O-ARM SCANNING THE PATIENT. BETWEEN THE ROBOT AND THE STERILE FIELD WAS A LANE TO PASS THROUGH THE OR. A STERILE HALF-SHEET WAS PLACED OVER THE ROBOT IN ORDER TO MAINTAIN ITS STERILITY. PATIENT MIDDLE OF ROOM ON TABLE, STERILE BACK TABLE OPPOSITE OR DOORS, ROBOT/NAV STATION IN FRONT LEFT CORNER. ANESTHESIA RIGHT SIDE. IT WAS CONGESTED BECAUSE OF THE LACK OF SPACE IN THE OR AND THE ROBOT HAD TO BE MOVED IN AND OUT OF THE STERILE FIELD TO ACCOMMODATE THE O ARM.

  Patient problems: Unspecified Infection

  MAUDE report 22739293 ↗
• MalfunctionAug 5, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED THE ROBOT RAN INTO THE POST OF THE PATIENT ARRAY NEAR THE CLAMP DURING A POSTERIOR SPINAL FUSION - PEDIATRIC. THE CAMERA HAD TO BE POSITIONED IN THE ANESTHESIA AREA MAKING IT HARD TO KEEP THE PATIENT STERILE AS WELL AS CAPTURE THE ARRAYS. THE ISSUE WAS WITH THE ROBOT. THEY WERE SENDING ROBOT TO TRAJECTORY TROUBLESHOOTING: HAD TO GET A NEW SPIN. WHILE SENDING TO A NEW TRAJECTORY THE ROBOT CAME CLOSE TO HITTING THE PATIENT ARRAY AGAIN HOWEVER, THEY STOPPED THE ROBOT MANUALLY AND MANIPULATED THE ARM OUT OF THE FIELD. THEY WERE ABLE TO SEND THE ROBOT TO THE TRAJECTORY AGAIN AND IT WORKED. SURGERY WAS DELAYED 10 MINUTES. NO PATIENT CONSEQUENCE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22713275 ↗