REAL INTELLIGENCE ROB10025Recalls & reported problems

Summary

The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 00885556757437), received between Aug 15, 2020 and Feb 12, 2026 — classified as 8 injuries, 33 malfunctions.

The most frequently reported specific device problem is “Intermittent Communication Failure” (21 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 25 most recent of 41 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 12, 2026Communication or Transmission Problem

  IT WAS REPORTED THAT, DURING A CORI ASSISTED TKA SURGERY, AFTER THE FOOT PEDAL AND HANDPIECE WERE DISCONNECTED AND RECONNECTED, THE SCREEN WENT BLACK FOR A FEW SECONDS AND ONE (1) REAL INTELLIGENCE TRACKING CAMERA STARTED FLASHING RED AND DISPLAYED A "CAMERA FAILED TO INITIALIZE" ERROR. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, WITH A CHANGE IN SURGICAL TECHNIQUE (MANUAL PROCEDURE). NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24324095 ↗
• MalfunctionDec 3, 2025Failure to Calibrate; Interrogation Problem; Failure to Calibrate; Interrogation Problem

  IT WAS REPORTED THAT, DURING A CORI ASSISTED TKA SURGERY, ONE (1) REAL INTELLIGENCE TRACKING CAMERA COULD NOT READ THE MARKERS ON THE CORI ROBOTIC DRILL AND THE CORI PROBE DURING THE CALIBRATION PHASE OF THE CASE. AN ERROR MESSAGE APPEARED REQUIRING THE BUMP SENSOR TO BE CALIBRATED. THE REPORTED DEVICE CALIBRATION IN THE ADMINISTRATOR MENU FAILED, EVEN AFTER A SYSTEM RESTART. IT WAS REPEATEDLY UNABLE TO CALIBRATE THE POINTS IN THE FIELD IN FRONT OF THE REPORTED DEVICE - THE RED DOTS REMAINED ON THE SCREEN. THEREFORE, IT COULD NOT PROCEED TO THE BUMP SENSOR RESTART PHASE. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A CHANGE IN SURGICAL TECHNIQUE (MANUAL TECHNIQUE). NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23711316 ↗
• MalfunctionOct 28, 2025Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT, DURING CORI ASSISTED UKR SURGERY, THE REAL INTELLIGENCE TRACKING CAMERA COULD NOT BE RECOGNIZED BY THE CONSOLE. AT THAT TIME, THE ALARM SOUNDED AND RED LIGHT FLASHED. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, AND WITH A CHANGE IN THE SURGICAL TECHNIQUE (MANUAL PROCEDURE). NO INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23404330 ↗
• MalfunctionOct 23, 2025Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, A REAL INTELLIGENCE TRACKING CAMERA FAILED TO DETECT FLAT MARKERS. INITIAL INTERMITTENT FLICKERING PROGRESSED TO CONSTANT DROPOUTS OF BOTH FEMORAL AND TIBIAL TRACKING ON THE CAMERA ORIENTATION ADJUSTMENT SCREEN, BEFORE LOSING ALL MARKER SIGNALS ENTIRELY. THIS PERSISTED EVEN AFTER TROUBLE SHOOTING. THE PROCEDURE WAS RESUMED, AFTER A SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23364725 ↗
• MalfunctionOct 3, 2025Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT, DURING CORI ASSISTED THA SURGERY, MANY ISSUES HAPPENED WITH HIP ON CORI REGISTRATION. ATTEMPTED REPLACING THE CONSOLE AND THEN, TRYING A NEW CAMERA. WITH THE CAMERA, COULD SEE THE SPHERES, BUT NOTHING ADVANCED THE SYSTEM TO COLLECT. THE PROCEDURE WAS RESUMED, WITHOUT DELAY, WITH A CHANGE IN SURGICAL TECHNIQUE: MANUAL PROCEDURE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23211647 ↗
• MalfunctionDec 19, 2024Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT, DURING A REAL INTELLIGENCE CORI ASSISTED TKA SURGERY, IT WAS NOTICED THAT ONE (1) REAL INTELLIGENCE TRACKING CAMERA WAS DAMAGED AS IT WAS NOT WORKING. TROUBLESHOOTING WAS ATTEMPTED USING DIFFERENT CABLES, BUT IT WAS DETERMINED THEY WERE NOT THE ISSUE. THE CAMERA HEAD RECEIVED POWER AND HAD A FLASHING RED LIGHT ON THE FRONT LED INDICATOR. IT WAS TRIED TO RESET THE BUMP SENSOR BELIEVING IT WAS AN ISSUE WITH THAT. THE CAMERA HOWEVER WAS NOT CONNECTING TO THE CONSOLE, AND AN ERROR CODE WAS DISPLAYED SAYING NO CAMERA RESPONSE DURING THE RESET PROCESS. THE CAMERA HEAD WAS NOT BEING RECOGNIZED BY THE CONSOLE IN THE CAMERA DIAGNOSTICS SECTION AS WELL. THE PROCEDURE WAS PERFORMED WITHOUT DELAY WITH A CHANGE IN SURGICAL TECHNIQUE BY USING MANUAL INSTRUMENTS, AND NO INJURIES WERE REPORTED AS A RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20981294 ↗
• MalfunctionOct 22, 2024Connection Problem; Connection Problem

  IT WAS REPORTED THAT, DURING A CORI ASSISTED TKA SURGERY, WHEN THE REAL INTELLIGENCE TRACKING CAMERA WAS CONNECTED A RED LIGHT STARTED TO APPEAR ON THE RIGHT SIDE, SO PROCEDURE 6.2 WAS FOLLOWED, ENABLE SHOCK SENSOR, BUT THE CAMERA SHOWED A CONNECTION ERROR. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, MANUALLY. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM. IT WAS THOUGHT IT MIGHT HAVE RUN OUT OF BATTERY BUT IT WAS CHARGED FOR 2 HOURS AND THE ERROR PERSISTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20507053 ↗
• MalfunctionAug 22, 2024Interrogation Problem; Interrogation Problem

  IT WAS REPORTED THAT, DURING SET UP FOR A CORI ASSISTED TKA SURGERY, IT WAS NOTICED THAT CAMERA BUMPED ERROR COMES ON THE SCREEN. THE ISSUE WAS RESOLVED AFTER RESETTING THE CAMERA BUMP SENSOR. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20034600 ↗
• MalfunctionJun 25, 2024Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  IT WAS REPORTED THAT, DURING THE SET UP FOR A CORI ASSISTED TKA SURGERY, A DAY PRIOR TO THE SURGERY, THE CAMERA WAS BEEPING AND FLASHING RED. THE TECH SUPPORT SAID THAT IT HAS TO ACTIVATE THE SHOCK SENSOR, AND AFTER DOING THIS, THE CAMERA GOT CONNECTED. DURING THE MORNING OF THE CASE, THE CORI WAS TURNED ON AND ALTHOUGH THE CAMERA WASN'T BEEPING OR FLASHING RED, IT WOULDN'T CONNECT AT THE CASE START UP SCREEN. IT WAS SHOWING AN ¿X¿ ICON INSTEAD OF THE GREEN CHECK MARK WHICH INDICATED THAT THE CAMERA WASN¿T CONNECTED. THE TECH SUPPORT INFORMED THAT THE SHOCK SENSOR HAS TO ACTIVATE, BUT INSTEAD OF ENTERING *1 IT MUST BE ENTERED *0. THAT ENDED UP FIXING THE PROBLEM. THE PROCEDURE WAS PERFORMED MANUALLY WITHOUT ANY DELAY. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19605538 ↗
• MalfunctionMar 19, 2024Erratic or Intermittent Display; Erratic or Intermittent Display

  IT WAS REPORTED THAT DURING CORI ASSISTED TKA SURGERY, THE REAL INTELLIGENCE TRACKING CAMERA ONLY DETECTED THE TRACKERS AT A DISTANCE OF 50CM AND IF THE CAMERA IS FURTHER THAN 50CM, THE TRACKERS WILL NOT BE RECOGNIZED. SURGERY WAS RESUMED WITHOUT ANY DELAY BY MANUAL PROCEDURE. NO INJURIES TO THE PATIENT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18936367 ↗
• InjuryAug 9, 2023Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT, DURING A CORI ASSISTED TKA SURGERY, WHEN PLUGGING THE DRILL, THE MONITOR AND TABLET WENT BLACK. TROUBLESHOOTING WAS DONE BY ATTEMPTING TO TURN THE MONITOR OFF AND ON AGAIN, UNPLUGGING THE TABLET, AND SECURING ALL OF THE CABLES IN THE CONSOLE; HOWEVER, THE MONITOR AND TABLET WOULD NOT TURN BACK ON. THEN IT WAS NOTICED THAT THE CAMERA HAD TWO RED DOTS THAT SHOULD HAVE BEEN GREEN. SINCE THE CORI SYSTEM WAS NOT ABLE TO BE USED, THE PROCEDURE WAS PERFORMED, AFTER A NON-SIGNIFICANT DELAY, VIA MANUAL SURGICAL TECHNIQUE. NO PATIENT INJURY WAS REPORTED DUE TO THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17494448 ↗
• InjuryJun 5, 2023False Alarm; False Alarm

  IT WAS REPORTED THAT, DURING A CORI ASSISTED TKA SURGERY, WHEN THEY WERE TRYING TO CALIBRATE THE HANDPIECE FOR THE CASE, A REAL INTELLIGENCE TRACKING CAMERA ERROR MESSAGE (CAMERA BUMP SENSOR DISABLED) WAS RECEIVED. THE REP TRIED TO COMPLETE THE CAMERA DIAGNOSTIC TEST, BUT IT WAS UNABLE TO COMPLETE IT DUE TO THE SURGEON WANTING TO MOVE FORWARD WITH MANUAL PROCEDURE. THE SURGERY WAS COMPLETED, AFTER A NON-SIGNIFICANT DELAY, CHANGING TO MANUAL PROCEDURE. NO INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17063015 ↗
• MalfunctionJun 8, 2022Intermittent Communication Failure; Intermittent Communication Failure

  IT WAS REPORTED THAT THE REAL INTELLIGENCE TRACKING CAMERA IS NOT BEING RECOGNIZED AND THERE IS A RED BLINKING LIGHT. THE CAMERA WAS NOT CONNECTING TO THE MACHINE. THE SHOCK RESET WAS DONE BUT THERE WAS NO DIFFERENCE. NO CASE INVOLVED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14630142 ↗
• MalfunctionMay 7, 2022Display or Visual Feedback Problem; Failure to Calibrate; Display or Visual Feedback Problem; Failure to Calibrate

  IT WAS REPORTED THAT DURING A CORI DEMO THE REAL INTELLIGENCE TRACKING CAMERA HAD A SOFT BLEEP, AND THE LED WAS RED. THE REAL INTELLIGENCE TRACKING CAMERA DID NOT PASS THE INITIAL TEST. AS THIS HAPPENED IN A DEMONSTRATION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14324700 ↗
• InjuryApr 22, 2022False Alarm; False Alarm

  IT WAS REPORTED THAT, DURING CORI ASSISTED SURGERY, THERE WAS A BUMP ERROR MESSAGE. WHEN THE REAL INTELLIGENCE TRACKING CAMERA WAS CONNECTED THE SCREEN FLIPPED BACK TO CHECK SCREEN AFTER POINT PROBE VERIFICATION. SWITCHING ETHERNET CABLE DID NOT SOLVE THE PROBLEM. PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, BY CHANGING TO MANUAL PROCEDURE. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14188546 ↗
• MalfunctionMar 30, 2022Intermittent Communication Failure; Intermittent Communication Failure

  IT WAS REPORTED THAT, WHILE MAPPING THE FEMUR IN A CORI SAWBONES DEMO, THEY RECEIVED AN ERROR SAYING: "CAMERA DISCONNECTED RE-ESTABLISH CONNECTIONS AND PRESS CONTINUE TO REINITIALIZE THE TRACKING SYSTEM". THEY PRESSED CONTINUE AND RECEIVED THE FOLLOWING ERROR: "CAMERA FAILED TO REINITIALIZE". THEY PRESS CONTINUE TO TRY AGAIN. THEY WENT TO CHECK THE ETHERNET CABLE AND OBSERVED TWO SOLID RED LIGHTS ON THE BACK OF THE CAMERA. THEY EXITED THE CASE, SWAPPED ETHERNET CABLES, AND WHEN THEY GOT TO THE CONNECTION SCREEN, THE CAMERA WOULD NOT CONNECT. THEY POWERED DOWN THE SYSTEM AND REBOOTED IT. WHEN THEY GOT BACK TO THE CONNECTION SCREEN, THE CAMERA WAS ABLE TO CONNECT. HOWEVER ONCE AGAIN, WHEN THEY PAINTED THE FEMUR THE CAMERA HAD THE SAME SET OF ERRORS AS DESCRIBED ABOVE. QUALITY RECOMMENDED RESETTING THE SHOCK SENSOR. THEY ATTEMPTED TO PERFORM THIS; HOWEVER, WHEN THEY WERE IN THE CODE INPUT SCREEN, THE CONSOLE WAS UNABLE TO CONNECT WITH THE CAMERA. IT SAID "SEARCHING FOR DEVICES...ERROR: CANNOT FINS ANY DEVICE". THEY RESTARTED THE SYSTEM AND TRIED THIS AGAIN AND RECEIVED THE SAME ERROR. FINALLY THEY ATTEMPTED TO GET THROUGH REGISTRATION AS QUICKLY AS POSSIBLE TO SEE IF THEY COULD GET TO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13957675 ↗
• MalfunctionMar 17, 2022Intermittent Communication Failure; Intermittent Communication Failure

  IT WAS REPORTED THAT, DURING CORI INSTALLATION, THE REAL INTELLIGENCE TRACKING CAMERA STARTED BEEPING. THE RED LED (DEVICE STATUS LED) ON THE FRONT RIGHT OF THE CAMERA WAS FLASHING RED. ACCORDING TO THE ATRACSYS USER MANUAL, "RED FLASHING INDICATES A FATAL ERROR, PLEASE CONTACT ATRACSYS". NO CASE INVOLVED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13795919 ↗
• MalfunctionMar 8, 2022Intermittent Communication Failure; Intermittent Communication Failure

  IT WAS REPORTED THAT, DURING A MARKETING DEMO, THE RED LED LIGHT OF THE REAL INTELLIGENCE TRACKING CAMERA WAS FLASHING WITH A BEEP SOUND. NO CASE INVOLVED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13694792 ↗
• MalfunctionFeb 9, 2022Intermittent Communication Failure; Intermittent Communication Failure

  IT WAS REPORTED THAT WHEN THEY CONNECTED THE CORI SYSTEM FOR THE FIRST TIME TO PERFORM THE NECESSARY SOFTWARE UPDATE, THE REAL INTELLIGENCE TRACKING CAMERA IMMEDIATELY STARTED FLASHING RED. IN ADDITION, THE CAMERA BEEPS PERMANENTLY. NO CASE INVOLVED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13501835 ↗
• MalfunctionNov 8, 2021Intermittent Communication Failure; Intermittent Communication Failure

  IT WAS REPORTED THAT, DURING CORI INSTALLATION, THE REAL INTELLIGENCE TRACKING CAMERA DID NOT CONNECT TO THE MODULE AND THERE WAS A RED LIGHT CONTINUOUSLY ON. THERE WAS ALSO AN AUDIBLE ALARM FROM THE CAMERA. NO CASE WAS INVOLVED; THEREFORE, THE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12771242 ↗
• MalfunctionNov 1, 2021Intermittent Communication Failure; Intermittent Communication Failure

  IT WAS REPORTED THAT DURING A CORI CADAVER LAB DEMONSTRATION. THE REAL INTELLIGENCE TRACKING CAMERA WAS NOT RECOGNIZED. THE LED LIGHTS WERE DISPLAYED NORMALLY BUT THE LOGO ON THE SCREEN SHOWED THE CAMERA AS UNRECOGNIZED. THEY TRIED TO CHANGE THE ETHERNET CABLE, HAD THE SAME ISSUE. THEY SWITCHED TO ANOTHER CAMERA AND THE CORI WORKED. AS THIS HAPPENED IN A DEMONSTRATION, THERE WAS NOT PATIENT INVOLVEMENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12727707 ↗
• MalfunctionOct 7, 2021Intermittent Communication Failure; Intermittent Communication Failure

  IT WAS REPORTED THAT THERE WAS NO CONTACT BETWEEN CORI AND REAL INTELLIGENCE TRACKING CAMERA. THEY TESTED WITH OTHER CAMERA AND IT GAVE GOOD RESULT. AS THIS HAPPENED IN A NON-SURGICAL ENVIRONMENT, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12595315 ↗
• MalfunctionSep 10, 2021Intermittent Communication Failure; Intermittent Communication Failure

  IT WAS REPORTED THAT, DURING CORI TRAINING, THE REAL INTELLIGENCE TRACKING CAMERA FELL FROM ITS TRIPOD AND HIT THE FLOOR. THEY WERE UNABLE TO RESET THE BUMP SENSOR SINCE THE CAMERA COULD NO LONGER BE RECOGNIZED BY THE CORI CONSOLE. THEY BEGAN TO HEAR A CONTINUOUS BEEPING NOISE AND BLINKING RED LIGHT. NO CASE INVOLVED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12456982 ↗
• MalfunctionSep 9, 2021Intermittent Communication Failure; Intermittent Communication Failure

  IT WAS REPORTED THAT DURING A CORI DEMO THE REAL INTELLIGENCE TRACKING CAMERA FELL OFF TRIPOD. COULD NOT BE DETECTED BY CORI CONSOLE AND BUMP SENSOR COULD NOT BE RESET. NO CASE INVOLVED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12447111 ↗
• MalfunctionJun 22, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT, DURING ASSEMBLY OF THE REAL INTELLIGENCE TRACKING CAMERA, THE CAMERA DISPLAYED THE RED BLINKING LIGHTS / FATAL ERROR. THE CAMERA WILL NOT CONNECT OR WILL NOT ALLOW TO DO A DIAGNOSTIC TEST OR ANY DEMO CASES. NO CASE INVOLVED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12043802 ↗