REAL INTELLIGENCE ROB10027Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00885556757451), received between Feb 1, 2021 and Dec 2, 2025 — classified as 3 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Erratic or Intermittent Display” (14 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 2, 2025No Visual Prompts/Feedback; No Visual Prompts/Feedback

  IT WAS REPORTED THAT, DURING A CORI ASSISTED TKA SURGERY, THE REAL INTELLIGENCE TABLET'S THE TOUCH SCREEN ACTIVITY WAS WORKING, AND THE POWER GREEN LIGHT WAS ON, BUT THE TABLET SCREEN WAS BLANK. NO INFO VISIBLE WAS ON THE TABLET SCREEN. CORI SYSTEM WAS RESTARTED, UNPLUGGED AND PLUGGED TABLET IN, AND NO DIFFERENCE HAPPENED. STERILITY RISK WAS IDENTIFIED, BY COMING CLOSE TO 24INCH MONITOR TO DO PLANNING SCREENS. THE PROCEDURE WAS RESUMED, AFTER A SIGNIFICANT DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23693293 ↗
• MalfunctionJun 30, 2025Erratic or Intermittent Display; Erratic or Intermittent Display

  IT WAS REPORTED THAT, DURING A REAL INTELLIGENCE CORI ASSISTED TKA SURGERY, A REAL INTELLIGENCE TABLET CONTINUES TO BLACK OUT RANDOMLY THROUGHOUT THE CASES, AND IT STALLS THE CASE. THE PROCEDURE WAS RESUMED, AFTER A SIGNIFICANT DELAY, WITH THE SAME DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22354717 ↗
• MalfunctionMay 15, 2025Erratic or Intermittent Display; Erratic or Intermittent Display

  IT WAS REPORTED THAT, DURING A REAL INTELLIGENCE CORI ASSISTED TKA SURGERY, A REAL INTELLIGENCE TABLET CAUSED SCREEN TO BLACKOUT MULTIPLE TIMES - RESULTING IN NOT BEING ABLE TO USE THE TABLET SINCE WE HAD TO UNPLUG IT. A DELAY GREATER THAN 30 MINUTES WAS REPORTED. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22023749 ↗
• MalfunctionMar 25, 2025Erratic or Intermittent Display; No Display/Image; Erratic or Intermittent Display; No Display/Image

  IT WAS REPORTED THAT, DURING A REAL INTELLIGENCE CORI ASSISTED TKA SURGERY, ONE (1) REAL INTELLIGENCE TABLET CAUSED THE SCREEN TO BLACK OUT 4 TIMES IN ONE CASE. THE SCREEN BLACKED OUT FOR ABOUT 15 SECONDS EACH TIME. THE SURGEON USED THE TABLET, AND IT NEEDED TO STAY PLUGGED IN. THE PROCEDURE WAS RESUMED AFTER A SIGNIFICANT DELAY USING THE SAME DEVICE, AND NO INJURIES WERE REPORTED AS A RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21693980 ↗
• MalfunctionMar 25, 2025Unexpected Shutdown; Unexpected Shutdown

  IT WAS REPORTED THAT DURING A TKA CORI ASSISTED SURGERY THE SCREEN OF ONE (1) REAL INTELLIGENCE TABLET WENT OFF. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A MANUAL PROCEDURE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21688048 ↗
• MalfunctionMar 18, 2025Erratic or Intermittent Display; Erratic or Intermittent Display

  IT WAS REPORTED THAT DURING A CORI-ASSISTED TKA SURGERY, THE REAL INTELLIGENCE TABLET, REMAINED PERMANENTLY ON A BLACK SCREEN. AFTER THE TABLET WAS UNPLUGGED FROM THE CONSOLE, THE OPERATION COULD BE COMPLETED. THE PROCEDURE WAS RESUMED AFTER A SIGNIFICANT DELAY. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21630283 ↗
• MalfunctionFeb 20, 2025Image Display Error/Artifact; Image Display Error/Artifact

  IT WAS REPORTED THAT DURING A TKA CORI ASSISTED SURGERY ONE (1) REAL INTELLIGENCE TABLET CONTINUED TO CAUSE THE ENTIRE CORI SYSTEM TO BLACK OUT. THIS OCCURRED MORE THAN FOUR TIMES THROUGHOUT ONE CASE AND HAS HAPPENED IN ALMOST EVERY CASE. THE PROCEDURE WAS RESUMED, AFTER A SIGNIFICANT DELAY, WITH THE SAME DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21420755 ↗
• MalfunctionDec 3, 2024Erratic or Intermittent Display; Erratic or Intermittent Display

  IT WAS REPORTED THAT, DURING SET-UP FOR A CORI ASSISTED SURGERY, THE SCREEN AND REAL INTELLIGENCE TABLET FLICKERED, SO THAT IT WAS IMPOSSIBLE TO PERFORM THE PROCEDURE. A STANDARD/MANUAL INSTRUMENTATION WAS USED AND THE SURGERY WAS COMPLETED, AFTER A NON-SIGNIFICANT DELAY. AFTER THE TM INSPECTION, IT TURNED OUT THAT THE PROBLEM IS THE TABLET. AFTER DISCONNECTING IT AND REPLACING IT FOR ANOTHER SYSTEM, IT WORKS PROPERLY. NO INJURY OR HARM WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20830494 ↗
• MalfunctionJan 7, 2024Erratic or Intermittent Display; Erratic or Intermittent Display

  IT WAS REPORTED THAT DURING A CORI-ASSISTED TKA, THE REAL INTELLIGENCE TABLET AND MAIN MONITOR WERE BLACKING OUT PERIODICALLY ABOUT TEN-TWELVE TIMES THROUGHOUT THE CASE. THE REAL INTELLIGENCE TRACKING CAMERA WAS ALSO NOT PICKING UP TIBIA TRACKER EVEN WHEN CLEANED TRACKERS AND CLOSE TO THE TRACKER. SURGERY WAS PERFORMED AFTER A DELAY GREATER THAN 30 MIN. IT IS UNKNOWN HOW SURGERY WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18461344 ↗
• InjuryDec 20, 2022Erratic or Intermittent Display; Erratic or Intermittent Display

  IT WAS REPORTED THAT, DURING THE SET-UP FOR A CORI ASSISTED SURGERY, A REAL INTELLIGENCE TABLET DISPLAYED A DVI INPUT ERROR WHICH RESULTS THAT THE CORI UNIT TURNS ON AND OFF. SURGERY WAS PERFORMED MANUALLY WITHOUT ANY DELAY, SINCE THIS WAS NOTICED DURING THE SET-UP FOR SURGERY, THE PATIENT WAS NOT YET INVOLVED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16014818 ↗
• MalfunctionSep 15, 2022Erratic or Intermittent Display; Unintended Application Program Shut Down; Erratic or Intermittent Display; Unintended Application Program Shut Down

  IT WAS REPORTED THAT, WHEN POWERED ON THE CONSOLE AND PLUGGED IN THE REAL INTELLIGENCE TABLET, THE SCREEN DID NOT FULLY COME ON. THE SYSTEM WAS RESTARTED AND IT DID COME ON, BUT TRYING TO CALIBRATE SHOWED A "COMMUNICATION ERROR" WITH EACH HANDPIECE. THE NEXT DAY A NEW TABLET WAS AVAILABLE AND WAS ABLE TO GET THE TABLET TO WORK WITH THE EXISTING CONSOLE AND HAD NO ISSUES WITH HANDPIECE CALIBRATION. AS THIS WAS NOTICED IN A NON-SURGICAL ENVIRONMENT, THERE WAS NOT ANY PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15434367 ↗
• MalfunctionAug 23, 2022Erratic or Intermittent Display; Unintended Application Program Shut Down; Erratic or Intermittent Display; Unintended Application Program Shut Down

  IT WAS REPORTED THAT, DURING A CORI-ASSISTED TOTAL KNEE ARTHROPLASTY, AFTER PLANNING WAS FINISHED UPON MOVING ONTO THE DISTAL CUT SCREEN, THE REAL INTELLIGENCE TABLET AND MONITOR BLACKED OUT. THIS WAS THEN FOLLOWED BY AN INTERNAL ERROR. SURGERY WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, BY DISCONNECTING THE TABLET AND CALIBRATING. THE PATIENT WAS NOT HARMED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15279560 ↗
• MalfunctionJul 7, 2022Erratic or Intermittent Display; Erratic or Intermittent Display

  IT WAS REPORTED THAT DURING A CORI ASSISTED TKA SURGERY, THE REAL INTELLIGENCE TABLET WOULD ONLY DISPLAY 3 COLOR TABS: RED, GREEN AND BLUE SHOW. THE TABLET WAS INACTIVE AND NOT RESPONDING TO THE TOUCH ELEMENTS AND THE LARGE 24INCH TOUCH SCREEN STILL WORKED BUT KEPT CUTTING OUT AFTER 30 SECONDS INTERVALS THROUGH OUT THE PROCEDURE. TO TROUBLESHOOT, IT WAS ENSURED DIRECT PUSH INSERTION OF THE TERMINAL CONTACTS OF THE PLUG INTO THE CORI CONSOLE, THE CABLES WERE STRAIGHT AND NOT TWISTED OR KINKED DURING STORAGE AND IN SURGERY AND THE CUT OUT STILL PERSISTS. THE PROCEDURE WAS COMPLETED, WITH A SIGNIFICANT DELAY, WITH THE MAIN MONITOR AND THE NURSE ADJUSTING THE PLAN TO THE SURGEON DESIRES. THE PATIENT WAS NOT HARMED BEYOND THE REPORTED PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14946235 ↗
• InjuryJun 27, 2022No Display/Image; No Display/Image

  IT WAS REPORTED THAT BEFORE A CORI ASSISTED UKR PROCEDURE, THE REAL INTELLIGENCE TABLET WOULD REMAIN CONSTANTLY BLACK, AND THE INDICATOR LIGHT ON THE FRONT OF THE TABLET FLASHES GREEN AND ORANGE ALTERNATELY. THE INDICATOR LIGHT ON THE CORI CONTROL UNIT LIGHTS UP WHITE ALL THE TIME. PROCEDURE CONTINUED WITH MANUAL INSTRUMENTS, WITHOUT A DELAY OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14830692 ↗
• InjuryMay 25, 2022Erratic or Intermittent Display; Erratic or Intermittent Display

  IT WAS REPORTED THAT DURING A CORI ASSISTED TKA SURGERY, WHEN THEY CONNECTED THE REAL INTELLIGENCE TABLET, BOTH SCREENS WENT BLACK. THEY TRIED TO DISCONNECT AND RECONNECT BUT THE ISSUE PERSISTED. THE PROCEDURE WAS COMPLETED BY CHANGING TO MANUAL PROCEDURE. PATIENT WAS NOT HARMED BEYOND THE PROBLEM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14493895 ↗
• MalfunctionMay 24, 2022Erratic or Intermittent Display; Erratic or Intermittent Display

  IT WAS REPORTED THAT, DURING A CORI ASSISTED SURGERY, THE REAL INTELLIGENCE TABLET KEPT BLACKING OUT. THE PROCEDURE WAS COMPLETED WITH THE MONITOR WITH A SIGNIFICANT DELAY. THE PATIENT WAS NOT HARMED BEYOND THE REPORTED PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14489181 ↗
• MalfunctionFeb 22, 2022Erratic or Intermittent Display; Erratic or Intermittent Display

  IT WAS REPORTED THAT, DURING A CORI ASSISTED TKA SURGERY, THE REAL INTELLIGENCE TABLET AND THE REAL INTELLIGENCE 24 IN. TOUCH SCREEN WENT BLACK EVERY TWO SECONDS, NO MATTER WERE THEY PUT THEM AND NO MATTER AT WHAT STAGE OF THE SURGERY THEY WERE. AFTER A FEW TIMES, WHILE WAITING FOR THE SCREENS TO WORK, THE REAL INTELLIGENCE CORI FROZE AND THEY HAD TO RESTART AND THEN THEY RECEIVED A SYSTEM CRITICAL ERROR. THEY USED THE MAIN MONITOR TO COMPLETE THE PROCEDURE WITH A SIGNIFICANT DELAY. THE PATIENT WAS NOT HARMED BEYOND THE REPORTED PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13580409 ↗
• MalfunctionFeb 1, 2021Erratic or Intermittent Display; Erratic or Intermittent Display

  IT WAS REPORTED THAT, AT THE START OF THE CASE, READY TO COLLECT THE INITIAL CHECKPOINTS FOR A CORI TKA PROCEDURE, AFTER PROPPING THE TABLET UP ON A MAYO STAND TO START CASE, IT KEPT BLACKING OUT EVERY 8 MINUTES. SURGERY WAS DELAYED MORE THAN 30 MIN. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11263436 ↗