REAL INTELLIGENCE ROB10003Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00885556756256), received between Jan 13, 2021 and Jun 25, 2025 — classified as 9 malfunctions.

The most frequently reported specific device problem is “No Display/Image” (7 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 25, 2025Computer Software Problem; Application Program Freezes or Fails to Launch; Computer Software Problem; Application Program Freezes or Fails to Launch

  IT WAS REPORTED THAT, DURING USE OF THE CORI SYSTEM, DATA POINTS CONTINUED TO BE COLLECTED EVEN WITHOUT THE FOOT PEDAL BEING PRESSED. IT IS SUSPECTED THAT ONE (1) REAL INTELLIGENCE 24 IN. TOUCH SCREEN MAY BE CAUSING THE ISSUE, RESULTING IN THE SCREEN ¿STICKING¿ DURING DATA COLLECTION. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A CHANGE IN SURGICAL TECHNIQUE (MANUAL INSTRUMENTATION). NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22332366 ↗
• MalfunctionApr 8, 2025Erratic or Intermittent Display; Erratic or Intermittent Display

  IT WAS REPORTED THAT, DURING CORI ASSISTED TKA SURGERY, THE SCREEN OF ONE (1) REAL INTELLIGENCE TABLET TURNED BLACK, FOLLOWED BY ONE (1) REAL INTELLIGENCE 24 IN. TOUCH SCREEN BLINKING INTERMITTENTLY. THE DOCTOR PROCEEDED WITH BONE RESECTION UNDER THESE BLACK SCREENS. HOWEVER, AFTER THE PROCEDURE WAS COMPLETED, THE SCREENS TURNED BACK ON, ALLOWING THE MEASUREMENT OF SURGICAL OUTCOMES. THE NEXT DAY, THE DEVICES WERE CHECKED, AND EXPERIENCED THE SAME ISSUE, EVEN AFTER REMOVING AND RE-PLUGGING THE TABLET'S CONNECTOR. THE TABLET AND THE TOUCHSCREEN WERE TESTED WITH ANOTHER CONSOLE BUT STILL OCCURRED. THE PROCEDURE WAS RESUMED, AFTER A SIGNIFICANT DELAY, WITH THE SAME DEVICES. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21802105 ↗
• MalfunctionDec 7, 2021No Display/Image; No Display/Image

  IT WAS REPORTED THAT DURING A CORI ASSISTED UKR WHEN THEY WENT TO CUT FEMUR, THE REAL INTELLIGENCE 24 IN. TOUCH SCREEN WENT BLACK. IT HAD POWER BUT FLASHED BOX THAT SAID "NO SIGNAL". THEY PROCEEDED TO UNPLUG THE DISPLAY PORT AND WHEN PLUGGED BACK IN, THE SCREEN CAME BACK ON. THEN WHEN THEY WENT TO CUT FEMUR, THE TABLET AND TOUCHSCREEN WENT BLACK AS THE BLUEMAN APPEARED ON THE CONSOLE. THEY PERFORMED HARD REBOOT AND LOGGED BACK INTO CASE AND RESUMED. PLAN HAD SAVED AND THEY EXECUTED THE CASE WITH CORI AND WERE ABLE TO FINISH. THE PROCEDURE WAS COMPLETED, WITH A NON-SIGNIFICANT DELAY, USING THE SAME DEVICE. PATIENT WAS NOT HARMED BEYOND THE PROBLEM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12957029 ↗
• MalfunctionNov 26, 2021No Display/Image; No Display/Image

  IT WAS REPORTED THAT, DURING SET UP FOR A CORI ASSISTED TKA SURGERY, THEY POWERED ON THE CORI AND THE REAL INTELLIGENCE 24 IN. TOUCH SCREEN WAS BLACK. THE BOTTOM RIGHT CORNER HAD A BLUE LIGHT INSTEAD OF A GREEN LIGHT. THEY PRESSED THE BOTTOM RIGHT AND THE DIFFERENT OPTIONS POPPED UP. THEY PRESSED POWER AND STILL BLACK. A SMALL BOX POPPED UP AND SAID ¿NO SIGNAL¿. THEY STILL COULD NOT GET THE SCREEN TO SHOW ANYTHING. THEY WENT TO THE BACK OF THE CORI AND UNPLUGGED THE DVI CABLE AND PLUGGED BACK IN, AND THE SCREEN WAS STILL BLACK. THEY UNPLUGGED IT AGAIN AND PLUGGED IT BACK IN AND CHECKED OTHER CABLES. THE SCREEN CAME ON. IT SEEMED LIKE IT WAS GETTING POWER BECAUSE THERE WAS THE BLUE LIGHT AT BOTTOM. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE WITHOUT SIGNIFICANT DELAYS. THE PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12878173 ↗
• MalfunctionNov 17, 2021No Display/Image; Connection Problem; No Display/Image; Connection Problem

  IT WAS REPORTED THAT, DURING SET UP FOR A CORI ASSISTED TKA SURGERY, THE REAL INTELLIGENCE 24 IN. TOUCH SCREEN BLACKED OUT AFTER REGISTERING HAND PIECE. THE WORDS ¿NO SIGNAL¿ CAME UP ON THE SCREEN AND NEITHER THE TOUCH SCREEN NOR THE REAL INTELLIGENCE TABLET HAD ANY SIGNAL. THE LIGHT ABOVE THE TABLET CORD PORT WAS BLINKING. THEY REBOOTED THE REAL INTELLIGENCE CORI AND THEY COULD PROCEED. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICES WITHOUT SIGNIFICANT DELAYS. SINCE INCIDENT OCCURRED BEFORE PROCEDURE, PATIENT WAS NOT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12827919 ↗
• MalfunctionAug 16, 2021No Display/Image; No Display/Image

  IT WAS REPORTED THAT DURING A SET UP FOR A CORI ASSISTED TKA SURGERY, THE REAL INTELLIGENCE 24 IN. TOUCH SCREEN BLACKED OUT RIGHT BEFORE CALIBRATION AND TURNED COMPLETELY OFF AND DID NOT COME BACK ON REMAINDER OF CASE. THEY DID NOTICE IT SAID IN SMALL LETTERS IN MIDDLE OF SCREEN ¿NO SIGNAL DETECTED¿ RIGHT BEFORE IT TURNED COMPLETELY OFF. THE PROCEDURE WAS COMPLETED, WITHOUT DELAY, USING THE TABLET. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM. AFTER CASE THEY TRIED TO UNPLUG MONITOR CORD ON BACK THAT WOULD SHUT IT OFF AND PLUGGED IT BACK IN, THE MONITOR WOULD SHOW GREEN LIGHT ON BOTTOM RIGHT HAND CORNER OF SCREEN BUT WOULD IMMEDIATELY TURN ORANGE AND IT WOULD SAY ¿NO SIGNAL DETECTED¿ IN MIDDLE OF SCREEN, WHICH MADE THEM BELIEVE THAT THE CORD WORKS FINE AND THAT IT IS THE MONITOR THAT IS DEFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12329246 ↗
• MalfunctionAug 12, 2021No Display/Image; No Display/Image

  IT WAS REPORTED THAT DURING A CORI ASSISTED SURGERY, THE REAL INTELLIGENCE 24 IN. TOUCH SCREEN BLACKED OUT AND TURNED COMPLETELY OFF BEFORE CALIBRATION BUT POPPED BACK ON BEFORE BURRING OF DISTAL FEMUR. THE PROCEDURE WAS COMPLETED USING THE TABLET FOR CALIBRATION AND UNTIL MONITOR CAME BACK ON DURING PLANNING SCREEN. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12316484 ↗
• MalfunctionApr 28, 2021No Display/Image; No Display/Image

  IT WAS REPORTED THAT, DURING ASSEMBLY OF CORI, THE 24 INCH TOUCHSCREEN MONITOR WILL TURN ON, YET NOTHING WILL APPEAR ON THE SCREEN. WHEN THEY ATTEMPTED TO PRESS "MENU", NOTHING HAPPENED, AND THE MONITOR TURNS OFF ON IT¿S OWN. THEY ENSURED EVERYTHING WAS PLUGGED IN APPROPRIATELY (THE TABLET WORKS AND PORTRAYS WHAT SHOULD BE ON THE MONITOR SCREEN), BUT THEY DON'T SEE ANYTHING ON THE MONITOR. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11741223 ↗
• MalfunctionJan 13, 2021No Display/Image; No Display/Image

  IT WAS REPORTED THAT, BEFORE STARTING A TKA CORI PROCEDURE, THE 24¿ MONITOR WAS NOT SHOWING START SCREEN AS SEEN ON TABLET. THE BOTTOM RIGHT CORNER HAD A RED LIGHT. AFTER MULTIPLE ATTEMPTS, THE CONTROL BUTTONS FINALLY ILLUMINATED TO HIT BLUE POWER. RED LIGHT TURNED GREEN, MONITOR DISPLAYED NO SIGNAL, THEN LIGHT TURNED BACK TO RED. AFTER A FEW ATTEMPTS, SYSTEM WAS FULLY SHUT OFF AND RESTARTED. THIS TIME 24¿ MONITOR SHOWED A SCREEN. ONCE THEY STARTED CASE, MONITOR BLANKED OUT AGAIN AFTER VIEWING TRACKERS POSITION TO ADJUST CAMERA. COULD NOT GET A FEED TO IT. TRIED EVERYTHING AND JUST WENT FROM RED, GREEN, NO SIGNAL, BACK TO RED. SHUT DOWN SYSTEM TO HOOK UP DVI TO EXTERNAL MONITOR JACK AND COULDN¿T GET A FEED. ENDED UP SWITCHING MONITORS FROM OTHER SYSTEM, POWERING UP CORI AND RESUMING OPERATION. THIS EVENT CONTRIBUTED TO SURGICAL DELAY OF MORE THAN 30 MIN. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11159224 ↗