ROSA ONE SURGICAL ASSISTANT (US) 3.1.6Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 03760244034793), received between Feb 28, 2023 and Aug 25, 2025 — classified as 5 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (4 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 25, 2025No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT A PATIENT THAT WAS OPERATED FOR A DEEP BRAIN STIMULATION (DBS) PROCEDURE AND HAD AN INTERNAL BRAIN BLEED FOLLOWING THE PROCEDURE. THE SPECIFIC PROCEDURE PERFORMED WAS REMOVAL OF EXISTING DBS HARDWARE AND PLACING ONE NEW ELECTRODE, UNILATERALLY. IT WAS DISCOVERED AFTER THE POST OP CT SCAN THAT AN INTERNAL BLEED HAD OCCURRED, EITHER DURING THE REMOVAL OF THE EXISTING HARDWARE, OR IMPLANTATION OF NEW HARDWARE. THE NEW DBS ELECTRODE THAT WAS IMPLANTED WAS MANUFACTURED BY MEDTRONIC. NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Intracranial Hemorrhage

  MAUDE report 22891716 ↗
• MalfunctionAug 5, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT ALL FOUR LEADS WERE ANTERIOR RELATIVE TO THE PLANNED TRAJECTORIES. 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 22723040 ↗
• MalfunctionApr 21, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT POST OP CT WAS MERGED WITH PREOP CT AND MRI AND THE ENTRY POINTS OF ALL TRAJECTORIES WERE 3-4MM OFF BUT THE TARGETS WERE ALL RELATIVELY ON TRAJECTORY. LASER REGISTRATION WAS PERFORMED AND VERIFICATION WAS ACCURATE. CONFIRMED THAT THE PATIENT WAS STILL SECURELY IN PINS/DID NOT MOVE. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION. 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 21878312 ↗
• MalfunctionDec 31, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE SURGEON PLANNED FOR 11 (ELEVEN) ELECTRODES TO BE IMPLANTED USING THE DEVICE. A POST OP SCAN WAS OBTAINED USING AN SOFTWARE TO CONFIRM THE ACCURACY OF THE IMPLANTATION. IT WAS OBSERVED THAT THE INSULAR ELECTRODE WAS OFF BY GREATER THAN 2MM. THE POST OP IMAGE SHOWED THAT THE BOLT/ENTRY POINT WAS OFF JUST FOR THAT ONE ELECTRODE. THERE WAS NO PATIENT HARM OR INJURY. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21047393 ↗
• MalfunctionOct 24, 2024Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THERE WERE SLIGHT INACCURACIES IN LAST COUPLE CASES WITH ELECTRODES APPEARING INFERIOR TO PLANNED TRAJECTORIES. NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20524126 ↗
• InjurySep 4, 2024Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT THE ROBOT WAS SLIDING DURING CASE. SUBSEQUENTLY THE CASE HAD TO BE CANCELLED AND THE PATIENT WAS ALREADY UNDER ANESTHESIA AND INCISION MADE. THE PATIENT HAD TO GO BACK UNDER ANESTHESIA FOUR DAYS LATER, WHEN THE CASE WAS COMPLETED. THE SURGEON DID REPORT BACK TO THE REP THREE DAYS AFTER THE COMPLETED CASE THAT THE PATIENT WAS DOING WELL. NO FURTHER INFORMATION KNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20134317 ↗
• InjuryAug 27, 2024Communication or Transmission Problem; Connection Problem; Unintended Movement; Communication or Transmission Problem; Connection Problem; Unintended Movement

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20077721 ↗
• MalfunctionJul 26, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THERE WAS A POSSIBLE SLIGHT ERROR IN ACCURACY DUE TO THE RESULT OF A MERGE ERROR. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION. NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19839649 ↗
• InjuryJul 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED DURING SURGERY OF A BIOPSY AND LITT PROCEDURE, THE FIDUCIAL REGISTRATION WAS PERFORMED. THE BIOPSY AND PLACEMENT OF THE LITT BOLT OCCURRED WITHOUT INCIDENT. DURING THE INTRAOPERATIVE MRI SCAN TO BEGIN THE LITT ABLATION, SURGEON NOTICED WHAT APPEARED TO BE A HEMORRHAGE IN THE PATIENT'S TEMPORAL LOBE NEAR THE LASER FIBER. SURGEON TRANSITIONED THE SURGERY TO AN OPEN CRANIOTOMY TO TREAT THE HEMORRHAGE. REPORTER IS CURRENTLY UNAWARE AT THIS TIME OF THE PATIENT'S CONDITION AFTER SURGERY. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Intracranial Hemorrhage

  MAUDE report 19652089 ↗
• MalfunctionDec 19, 2023Incorrect Measurement; Incorrect Measurement

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18355367 ↗
• InjuryJul 13, 2023Computer Software Problem; Computer Software Problem

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17315144 ↗
• InjuryFeb 28, 2023Computer Software Problem; Computer Software Problem

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16452024 ↗