Real Intelligence ROB30001Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556919712), received between Mar 30, 2026 and Apr 16, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Application Program Problem” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 16, 2026Application Program Problem: Parameter Calculation Error

  IT WAS REPORTED THAT, DURING A REAL INTELLIGENCE CORI ASSISTED TSA SURGERY, WHEN TRYING TO UNLOCK THE REAL INTELLIGENCE ROBOTIC DRILL, A DISCONNECT ERROR APPEARED. THE PLUG ON THE DRILL WAS STILL HOT AFTER STERILIZED. EVENTUALLY THE TEAM WAS ABLE TO CALIBRATE AND MOVE FORWARD. LATER IN THE CASE WHEN MAPPING THE HUMERUS, THE DATA POINTS AND MODEL SEEMED TO BE JUMPING AROUND AND OFF THE MODEL. THEY WERE UNABLE TO HAVE THE MODEL TURN WHITE, SO THEY BACKED THE CASE UP TO RECOLLECT THEIR LANDMARK POINTS AND TRY AGAIN. AFTER ANOTHER UNSUCCESSFUL ATTEMPT, THEY WENT TO TRY AND BACK UP AGAIN WHICH LED TO AN INTERNAL ERROR POPPING UP AND MAKING THEM QUIT THE CASE. THE PROCEDURE WAS RESUMED, AFTER A NON SIGNIFICANT DELAY, WITH MANUAL PROCEDURE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24903734 ↗
• MalfunctionMar 30, 2026Application Program Problem

  IT WAS REPORTED THAT, BEFORE A CORI ASSISTED TSA, THE PRE-OP PLAN WAS UPLOADED TO REAL INTELLIGENCE CORI CONSOLE XT, ALL OF THE PATIENT INFORMATION LOADED IN AND PRESUMED TO LOOK COMPLETELY FINE. WHEN PRESSING BEGIN OPERATION, AN ERROR WAS ENCOUNTERED THAT STATED THE PRE-OP PLAN FILE CANNOT BE ACCESSED. THE CASE WAS DELETED AND UPLOADED MULTIPLE TIMES. ENCOUNTERED THE SAME ERROR EVERY TIME. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, WITH A CHANGE IN SURGICAL TECHNIQUE TO MANUAL PROCEDURE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24724159 ↗