Real Intelligence ROB20000Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00885556773673), received between Oct 11, 2021 and May 20, 2022 — classified as 2 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Unintended Application Program Shut Down” (6 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 20, 2022Unintended Application Program Shut Down; Unintended Application Program Shut Down

  IT WAS REPORTED THAT DURING SET UP FOR A CORI ASSISTED TKA SURGERY, THE REAL INTELLIGENCE ROBOTIC DRILL WOULD NOT CONNECT TO PROCEED WITH CALIBRATION. THE WHITE LIGHT ON THE CONSOLE CONTINUED TO FLASH AND A DRILL DEACTIVATED NOTIFICATION APPEARED (B)(4). THEY ATTEMPTED TO PRESS CONTINUE AND THE BUTTONS WERE ALL GRAYED OUT. A HARD POWER DOWN AND ADMINISTRATOR SCREEN WAS ENTERED BUT RECEIVED THE SAME NOTIFICATION IN ADDITION TO AN INTERNAL ERROR CONTACT CUSTOMER SUPPORT SCREEN (B)(4). THE PROCEDURE WAS COMPLETED, WITHOUT DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM. AFTER THE CASE, TROUBLE SHOOTING WAS RE-ATTEMPTED AND THE RI ROBOTIC DRILL ATTACHMENT BECAME STUCK (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14455047 ↗
• InjuryMay 14, 2022Unintended Application Program Shut Down; Unintended Application Program Shut Down

  IT WAS REPORTED THAT DURING A CORI ASSISTED TKA SURGERY, WHEN THE SURGEON BEGAN TO MILL THE DISTAL FEMUR, THE REAL INTELLIGENCE ROBOTIC DRILL WOULD MAKE A LOUD SCREECH. THEY CHECKED THE GUARD AND THE SCREECH CONTINUED. THEY DECIDED TO SWAP THE LONG ATTACHMENT AND HIT THE CHANGE BURR ICON, PROCEEDED, AND THEN RECEIVED A DRILL COMMUNICATION ERROR FOLLOWED BY AN INTERNAL COMMUNICATION ERROR. THEY WENT INTO DRILL DIAGNOSTICS AND COULD NOT DISSEMBLE THE RI ROBOTIC DRILL ATTACHMENT FROM THE DRILL. THE PROCEDURE WAS COMPLETED, WITH A NON-SIGNIFICANT DELAY, BY CHANGING TO MANUAL PROCEDURE. PATIENT WAS NOT HARMED BEYOND THE PROBLEM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14403179 ↗
• MalfunctionMar 18, 2022Unintended Application Program Shut Down; Unintended Application Program Shut Down

  IT WAS REPORTED THAT, DURING SET UP FOR A CORI LAB, THEY ENCOUNTERED TWO REAL INTELLIGENCE ROBOTIC DRILL THAT SHOWED A CRITICAL DRILL ERROR WHEN A ROBOTIC DRILL DIAGNOSTICS TEST WAS PERFORMED. IT WOULD NOT ALLOW FOR THE DRILLS TO BE RECOGNIZED BY THE SYSTEM , AND THE REAL INTELLIGENCE CORI WOULD GIVE THE SYSTEM FAULT: CRITICAL ERROR UPON PLUGGING THE HANDPIECES IN. NEITHER OF THE HANDPIECES WOULD REGISTER WHEN A CASE WAS MADE AND THE DRILLS WERE PLUGGED IN TO CALIBRATE. THEY TOOK THE TOP OF THE CORI UNIT OFF TO ENSURE THAT THE CONSOLE WAS WORKING PROPERLY AND IT WAS. THEY COULD NOT GO FORWARD WITH EITHER OF THE DRILLS. NO CASE INVOLVED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13815983 ↗
• MalfunctionJan 4, 2022Application Program Problem: Parameter Calculation Error; Application Program Problem: Parameter Calculation Error

  IT WAS REPORTED THAT DURING A CORI ASSISTED TKA SURGERY WHILE MAPPING THE TIBIA THE ENTIRE TIBIA TURNED YELLOW AS IF IT WAS ALL FILLED IN. THEY TURNED ON THE GREEN POINTS AND PROCEEDED AS NORMAL WITHOUT ISSUE (CASE- (B)(4)). WHEN THE SURGEON FINISHED MILLING THE MEDIAL DISTAL FEMORAL CONDYLE, MOVED TO THE LATERAL, THEY RECEIVED A SYSTEM TIME OUT (CASE- (B)(4)). THEY HIT CONTINUE AND PROCEEDED WITHOUT FURTHER ISSUE. 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 13153319 ↗
• InjuryDec 8, 2021Unintended Application Program Shut Down; Unintended Application Program Shut Down

  IT WAS REPORTED THAT DURING THE CALIBRATION SET UP FOR A CORI ASSISTED SURGERY, THE REAL INTELLIGENCE ROBOTIC DRILL NOTIFIED THAT IT WAS ALMOST TIME TO SERVICE THE DRILL BUT COULD STILL CONTINUE, HOWEVER, WHEN THEY HIT CONTINUE, IT WOULD JUST QUIT OUT OF CASE AND NOT LET THEM MOVE FORWARD. THEY WENT TO ADMIN SCREEN TO RUN A TEST ON THE HANDPIECE AND THE BUR WOULD NOT EVEN LOCK IN TO MOVE THROUGH THE TEST AND THE TEST KEPT FAILING. THE RI ROBOTIC DRILL ATTACHMENT WAS STUCK ON THE REAL INTELLIGENCE ROBOTIC DRILL AFTER THEY TRIED CALIBRATING. THE PROCEDURE WAS COMPLETED, WITHOUT DELAY, BY CHANGING IN SURGICAL TECHNIQUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12964745 ↗
• MalfunctionOct 26, 2021Unintended Application Program Shut Down; Unintended Application Program Shut Down

  IT WAS REPORTED THAT DURING SET UP FOR A CORI ASSISTED TKA SURGERY, THE REAL INTELLIGENCE ROBOTIC DRILL HAD A COMMUNICATION FAILURE AT UNLOCK SCREEN, FOLLOWED BY INTERNAL ERROR WHEN EXITING CASE. THEY PROCEEDED TO CREATED A NEW CASE, BUT COULD NOT CLEAR. THEY TRIED TO RESTART THE SYSTEM BUT THE ISSUE PERSISTED. THE PROCEDURE WAS COMPLETED, WITHOUT DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12701395 ↗
• MalfunctionOct 11, 2021Unintended Application Program Shut Down; Unintended Application Program Shut Down

  IT WAS REPORTED THAT AFTER A CORI ASSISTED TKA SURGERY AND WHILE TESTING A NEW REAL INTELLIGENCE ROBOTIC DRILL, IT WOULD NOT LOCK IN A BURR. ALSO, THE REAL INTELLIGENCE CORI HAD A CRITICAL ERROR AND AN INTERNAL ERROR, AND A SYSTEM FAULT COMMUNICATION FAILURE APPEARED ON THE SCREEN. SINCE THIS HAPPENED AFTER PROCEDURE, THERE WAS NOT PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12610638 ↗