REAL INTELLIGENCE ROB10026Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00885556757444), received between Apr 11, 2021 and Aug 26, 2025 — classified as 5 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Activation Problem” (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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 26, 2025Connection Problem; Connection Problem

  IT WAS REPORTED THAT, DURING CORI ASSISTED TKA SURGERY, THE REAL INTELLIGENCE FOOT PEDAL SHOWED A DISCONNECT ERROR ON BUR INITIAL CUT, FOR DISTAL FEMUR. REGARDLESS OF TROUBLESHOOTING, THE ISSUE PERSISTED. HOWEVER, IT SEEMED TO BE WORKING ON SECOND CASE. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A CHANGE IN THE SURGICAL TECHNIQUE (MANUAL TECHNIQUE). NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22900971 ↗
• MalfunctionApr 22, 2025Activation Problem; Activation Problem

  IT WAS REPORTED THAT, DURING MACHINE TESTING, IT WAS FOUND THAT ONE (1) REAL INTELLIGENCE FOOT PEDAL, ONCE PRESSED DID NOT GET RELEASED, THE BURR KEPT SPINNING. THE FOOT PEDAL WAS FAULTY. AS THIS WAS NOTICED IN PREVENTATIVE MAINTENANCE, THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21880917 ↗
• MalfunctionMar 26, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A TKA CORI ASSISTED SURGERY THE CORD OF ONE (1) REAL INTELLIGENCE FOOT PEDAL WAS PINCHED UNDER THE BED, CUTTING ONE OF THE WIRES INSIDE THE RUBBER CASING. THIS CAUSED THE CORI TO DISPLAY A BLUE MANUAL IMAGE ON THE FRONT SCREEN, PREVENTING THE USE OF THAT FOOT PEDAL. THE PROCEDURE WAS RESUMED AFTER A NON-SIGNIFICANT DELAY BY CHANGE TO MANUAL PROCEDURE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21697185 ↗
• MalfunctionDec 20, 2024Activation Problem; Activation Problem

  IT WAS REPORTED THAT, DURING A REAL INTELLIGENCE CORI ASSISTED TKA SURGERY, THE BLACK FOOT BUTTON OF ONE (1) REAL INTELLIGENCE FOOT PEDAL TRIGGERED PERMANENTLY ON ITS OWN, WHICH MADE IT IMPOSSIBLE TO CONTINUE WITH THE OPERATION. DESPITE DISCONNECTING SEVERAL TIMES, THE PROBLEM COULD NOT BE FIXED. THE PROCEDURE WAS RESUMED AFTER A NON-SIGNIFICANT DELAY CHANGING TO A MANUAL PROCEDURE TECHNIQUE, AND NO INJURIES WERE REPORTED AS A RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20985230 ↗
• MalfunctionNov 29, 2024Connection Problem; Activation Problem; Connection Problem; Activation Problem

  IT WAS REPORTED THAT, DURING A CORI-ASSISTED TKA, ON THE STEP OF FLEXION RANGE COLLECTION THE REAL INTELLIGENCE FOOT PEDAL WAS SLOW TO RESPOND. THEN, IT WORKED WITHOUT PRESSING DURING THE TIBIA ADD POINTS STEP. THE PROBLEM WAS RESOLVED BY PRESSING THE FOOT SWITCH AGAIN SEVERAL TIMES OR LEAVING IT ALONE, SO THE PROCEDURE WAS CONTINUED, AFTER A NON-SIGNIFICANT DELAY, WITH THE SAME DEVICE. PATIENT WAS NOT HARMED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20808977 ↗
• MalfunctionApr 10, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT, DURING A CORI ASSISTED TKA SURGERY, THE ORANGE BUTTON OF THE REAL INTELLIGENCE FOOT PEDAL CANNOT BE STEPPED ON. THE SURGEON HAS CHANGED TO CONVENTIONAL INSTRUMENT. THE SURGERY WAS COMPLETED AFTER A NON-SIGNIFICANT DELAY. NO INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19085132 ↗
• MalfunctionMar 12, 2024Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING A CORI ASSISTED TKA SURGERY, THE REAL INTELLIGENCE FOOT PEDAL STOPPED WORKING DURING POST-OP RANGE OF MOTION COLLECTION. ALL ARRAYS WERE BEING SEEN, BUT THE PEDAL DID NOT COLLECT ANYTHING. THE DEVICE WAS UNPLUGGED AND PLUGGED BACK IN BUT THE PROBLEM PERSISTED. THE PROCEDURE WAS RESUMED, AFTER A SIGNIFICANT DELAY, WITH A S+N BACK UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18888139 ↗
• MalfunctionDec 12, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A CORI-ASSISTED TKA, THE REAL INTELLIGENCE FOOT PEDAL GOT STUCK AND WOULD NOT RAISE UP BY ITSELF. WHEN GETTING STUCK THE USER HAD TO MANUALLY RAISE THE PEDAL TO MAKE SURE THE BURR WOULD NOT SPIN. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, WITH THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18313149 ↗
• MalfunctionDec 5, 2023Activation Problem; Activation Problem

  IT WAS REPORTED THAT DURING A CORI-ASSISTED TKA, WHILE MILLING OF THE DISTAL FEMUR, THEY NOTICED THE ORANGE PEDAL WAS NOT WORKING AS IT SHOULD. THE HANDPIECE RAN AFTER THE SURGEON REMOVED HIS FOOT FROM THE PEDAL. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, WITH THE SAME DEVICE. NO INJURY TO PATIENT OR INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18271443 ↗
• InjuryNov 28, 2023Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING CORI ASSISTED TKA SURGERY, THE REAL INTELLIGENCE FOOT PEDAL GAVE AN ERROR SAYING THAT THERE WAS A CONNECTION ERROR. THE FOOT PEDAL STOPPED WORKING, EITHER PEDALS NOT FUNCTIONING. TROUBLESHOOTING WAS ATTEMPTED BUT TO NO AVAIL WITH THE FOOT PEDAL COMPLETELY NOT RESPONSIVE. SURGERY WAS RESUMED AFTER A NON-SIGNIFICANT DELAY BY MANUAL PROCEDURE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THE PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18222689 ↗
• InjuryAug 9, 2023Activation Problem; Activation Problem

  IT WAS REPORTED THAT, DURING A CORI ASSISTED TKA, A REAL INTELLIGENCE FOOT PEDAL WAS WORKING FINE DURING THE CUT DISTAL FEMUR STAGE, BUT WHEN AT THE TIBIA STAGE, IT WOULD NOT RUN. THE TIBIAL TRACKER AND DRILL WERE BOTH IN VIEW. TROUBLESHOOTING WAS PERFORMED BY UNPLUGGING AND PLUGGING BACK THE FOOT PEDAL CORD, SWAPPING THE DRILL, AND A HARD RESTART; BUT THESE ACTIONS DID NOT RESOLVE THE ISSUE. THE PROBLEM WAS RESOLVED, AFTER A NON-SIGNIFICANT DELAY, WITH A CHANGE TO A MANUAL TECHNIQUE, BY USING A SAWBONE ALONG WITH A NEW ORANGE PEDAL. NO PATIENT INJURY WAS REPORTED DUE TO THIS ISSUE. THE REPORTED PEDAL WAS PLUGGED AFTERWARDS AND IT WOULD NOT WORK; IT WOULD RUN DURING A DRILL TEST BUT NOT ON THE TIBIAL CUT SCREEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17494386 ↗
• InjuryMay 23, 2023Activation Problem; Activation Problem

  IT WAS REPORTED THAT, DURING A CORI ASSISTED TKA SURGERY, AFTER A SUCCESSFUL CALIBRATION, TEST SPIN, AND REGISTRATION USING THE BLACK FOOT PEDAL, THE ORANGE REAL INTELLIGENCE FOOT PEDAL WOULD NOT ACTIVATE THE ROBOTIC DRILL. ONCE THE DRILL CAME INTO CONTACT WITH THE SURFACE OF THE BONE, IT WOULD EXPOSE, BUT IT WOULD NOT SPIN. NEW BUR AND NEW HANDPIECE USED AND RECALIBRATED, BUT THE BUR WOULD NOT SPIN. THE SURGERY WAS COMPLETED AFTER A NON-SIGNIFICANT DELAY WITH MANUAL INSTRUMENTATION. AFTERWARD, THE FOOT PEDAL WAS TESTED WITH A KPC TEST AND NO ERRORS DISPLAYED. THE BUR WORKED DURING DIAGNOSTICS. NO INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16985261 ↗
• MalfunctionFeb 14, 2023Unintended Application Program Shut Down; Activation Problem; Unintended Application Program Shut Down; Activation Problem

  IT WAS REPORTED THAT, DURING A CORI-ASSISTED TKA PROCEDURE, THE REAL INTELLIGENCE FOOT PEDAL DISCONNECTED AND WAS IMPOSSIBLE TO RECONNECT. IT HAD SHOWN SOME SIGNS OF WEAKNESS A FEW MINUTES BEFORE, IT DID NOT RESPOND WHEN PRESSED. THEY CHANGED PEDALS AND HAD TO RESTART THE SYSTEM BECAUSE IT HAD CRASHED DUE TO THE DISCONNECTED PEDAL. EVERYTHING WORKED FINE ONCE RESTARTED THE SYSTEM AFTER A NON-SIGNIFICANT DELAY, WITH A BACK-UP DEVICE. PATIENT IS DOING VERY WELL. THE DAMAGED PEDAL WAS TESTED AGAIN BUT IT DID NOT WANT TO CONNECT AT ALL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16371701 ↗
• InjuryJul 26, 2022Intermittent Communication Failure; Intermittent Communication Failure

  IT WAS REPORTED THAT THE LED ON THE REAL INTELLIGENCE FOOT PEDAL CONNECTOR OF THE CONSOLE WAS BLINKING. ON REGISTRATION IT WAS FOUND THAT THE REAL INTELLIGENCE FOOT PEDAL WAS NOT GETTING DETECTED. THIS WAS NOTICED DURING SET UP, AND THE PROCEDURE WAS PERFORMED, WITH A DELAY OF LESS THAN 30 MIN, CHANGING TO A NAVIO PROCEDURE. THE PATIENT WAS NOT HARMED BEYOND THE REPORTED PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15108620 ↗
• InjuryApr 18, 2022Intermittent Communication Failure; Intermittent Communication Failure

  IT WAS REPORTED THAT, DURING THE FEMUR MAPPING STAGE IN A CORI ASSISTED SURGERY, THE ERROR "FOOT PEDAL CABLE DISCONNECTED" POPPED ON SCREEN. AFTER RESETTING THE FOOT PEDAL CONNECTION, THE ERROR "PEDAL CABLE DISCONNECTED" APPEARED DURING THE FEMUR CUT STAGE. THE SURGERY WAS COMPLETED WITH MANUAL INSTRUMENTATION WITH A SIGNIFICANT DELAY. THE PATIENT WAS NOT HARMED BEYOND THE REPORTED PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14132549 ↗
• MalfunctionJul 28, 2021Circuit Failure; Circuit Failure

  IT WAS REPORTED THAT, DURING A SAWBONES TRIAL IN A CORI-LAB, THEY GOT AN IMMEDIATE SHUTDOWN OF THE SYSTEM (LEAVING "BLUE MAN" ICON ON CONSOLE) (B)(4) WHEN PRESSING THE CENTER PEDAL BUTTON OF REAL INTELLIGENCE FOOT PEDAL. REPEATABLE WITHIN UKA APP, BUT THEN NOTICED THE THAT FOOTPEDAL CABLE WAS SHORN AND WIRES WERE EXPOSED THROUGH INSULATION. AFTER A NEW NON-DAMAGED PEDAL WAS USED, THE PROBLEM WENT AWAY. WHEN RESTORING THE PEDAL OF ISSUE, THE PROBLEM DID NOT HAPPEN UNTIL THE OPENING IN THE INSULATION WAS MANIPULATED/PRESSED. THEY THOUGH THAT IT WAS POTENTIALLY A SHORT OF A 24V LINE, WHICH WOULD LIKELY LEAD TO THAT SORT OF SHUTDOWN. UPON INSPECTION OF THE LOGS, THERE WAS NO INDICATION OF THE PROBLEM, WHICH IS THE CURRENT DESIGN. HOWEVER, A DAMAGED FOOTPEDAL CABLE (A LIKELY SITUATION IN THE FIELD) WOULD LEAD TO THIS EFFECT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12243489 ↗
• MalfunctionApr 11, 2021Intermittent Communication Failure; Intermittent Communication Failure

  IT WAS REPORTED THAT, DURING PREVENTATIVE MAINTENANCE OF CORI, THEY ENTERED AN EXISTING TEST CASE AND THE PEDAL WOULD NOT CONNECT. THEREFORE, THEY UNPLUGGED AND RE-PLUGGED THE PEDAL, BUT THE CONNECTION LIGHT WOULD NOT LIGHT UP. SO, THEY POWERED DOWN SYSTEM, RESTARTED AND CREATED NEW TEST CASE. THE PEDAL CONNECTED AT CONNECTION SCREEN, AND THEY ADVANCED TO BUR OPTIONS, BUT A PEDAL DISCONNECTION POP-UP. THEY UNPLUGGED AND RE-PLUGGED TO CLEAR IT, BUT IT TOOK MULTIPLE TRIES. THERE WAS NO PATIENT INVOLVEMENT. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11646962 ↗