ROBOT ROSA ONE (USA) 3.1.4.0Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 03760244033765), received between Nov 29, 2021 and Feb 3, 2025 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (3 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 3, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED POST-OPERATIVELY THERE WAS A MERGE ISSUE. AFTER VERIFYING MERGE OF OAM SCAN, ENTRY POINTS LOOKED WRONG, BUT WHEN REMERGING THE SCAN TO THE PREVIOUS ORAM SPIN, IT WAS ABLE TO RIGHT THE MERGE. THE ORIGINAL MERGE LOOKED NORMAL, BUT SEEMS IT WAS OFF. INVESTIGATION RESULTS CONFIRMED ENTRY POINT INACCURACY. NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21293634 ↗
• MalfunctionAug 16, 2023Output Problem; Output Problem

  IT WAS REPORTED DURING AN RNS IMPLANTATION SURGERY, AFTER PLACEMENT OF BOTH LEADS (TRAJECTORIES ¿R AMYGDALA¿ AND ¿R HIPPOCAMPUS¿) AN O-ARM CT SCAN WAS TAKEN AND MERGED TO THE REGISTRATION CT. THE ¿R HIPPOCAMPUS¿ LEAD WAS SUPERIOR TO THE PLANNED TRAJECTORY BY ABOUT 5 MM. THE ¿R AMYGLADA¿ LEAD WAS MINIMALLY SUPERIOR AND ANTERIOR TO THE PLANNED TRAJECTORY, BUT WAS DETERMINED TO BE SATISFACTORY. A NEW TRAJECTORY WAS PLANNED TO REPLACE ¿R HIPPOCAMPUS¿. THIS NEW TRAJECTORY (¿TRAJECTORY 1¿) WAS PLANNED INFERIOR TO THE ¿R HIPPOCAMPUS¿ TRAJECTORY. THE LEAD WAS REMOVED AND RE-PLACED AT ¿TRAJECTORY 1¿. ANOTHER O-ARM CT SCAN WAS TAKEN AND MERGED TO THE REGISTRATION CT. THE LEAD WAS ALSO ABOUT 5 MM SUPERIOR TO ¿TRAJECTORY 1¿ AND ABOUT 3 MM SUPERIOR TO ¿R HIPPOCAMPUS.¿ THE SURGEON DETERMINED THAT THE LEAD PLACEMENT WAS SUFFICIENT AND DID NOT NEED FURTHER IMPROVEMENT. SURGEON ALSO NOTED THAT IT WAS POSSIBLE THE HEAD HAD MOVED IN THE CLAMP, AS THERE WAS SOME SLIGHT MOVEMENT TO THE HEAD FIXATION. NO OTHER ISSUES OCCURRED DURING THE PROCEDURE AND THIS RESULTED IN A 30 MINUTE DELAY TO THE CASE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17555520 ↗
• InjuryDec 7, 2021Positioning Failure; Unintended Collision; Incorrect, Inadequate or Imprecise Result or Readings; Positioning Failure; Unintended Collision; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT IT WAS COMPLETED A 13 TRAJECTORY BILATERAL SEEG CASE USING THE ROSA ROBOT WITH A COMPANY REPRESENTATIVE PRESENT. THE PATIENT WAS PUT TO SLEEP, PINNED IN A MAYFIELD HEAD CLAMP, ATTACHED TO ROSA AND REGISTERED USING CONTACTLESS REGISTRATION. ALL 13 TRAJECTORIES WERE PLACED AS NORMAL. THE COMPANY REPRESENTATIVE THEN RECEIVED AN EMAIL THE NEXT DAY FROM THE SURGEON STATING THAT THE PATIENT HAD A BRAIN HEMORRHAGE THAT WAS SEEN ON A POST OPERATIVE CT SCAN. THE INFORMATION THAT WAS GIVEN WAS THAT THE MAJORITY OF THE ELECTRODES WERE PLACED CORRECTLY, BUT A COUPLE WERE OFF TARGET.

  Patient problems: Hematoma; Intracranial Hemorrhage; Paralysis

  MAUDE report 12948229 ↗
• InjuryNov 29, 2021Computer Software Problem; Incorrect, Inadequate or Imprecise Result or Readings; Computer Software Problem; Incorrect, Inadequate or Imprecise Result or Readings

  ZIMMER BIOMET MEDTECH HAS BEEN MADE AWARE OF A SERIOUS ADVERSE EVENT THAT OCCURRED AT THE HOUSTON VA, IN WITH ROBOT S/N (B)(6). A SYSTEMATIC REGISTRATION ERROR APPEARED TO BE PRESENT WITH AN INTRAOPERATIVE O-ARM SPIN. THE DAY OF THESE CASE, WEDNESDAY (B)(6), AN INACCURACY OCCURRED. ON THE FOLLOWING DAY, THE (B)(6), THE PATIENT HAD AN INTRAPARENCHYMAL HEMATOMA OF ABOUT 2 CM IN SIZE. THE PATIENT IS ANTICIPATED TO MAKE A FULL RECOVERY.

  Patient problems: Hematoma

  MAUDE report 12882859 ↗