Optical distance sensor 174007Recalls & reported problems
Medtech · OPTICAL DISTANCE SENSOR (V3) instrument Rosa One 3.1 (brain application) Optical distance sensor for contactless location of anatomical structures or landmarks. Used for markerless automatic registration and free-hand navigation · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03760244032195), received between Feb 22, 2023 and May 26, 2023 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (2 reports).
1 other recall cover devices cleared under the same FDA submission (K200511, K231103); they may or may not involve this specific model.
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
Device problems
- Incorrect, Inadequate or Imprecise Result or Readings2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 26, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17011521 ↗MalfunctionFeb 22, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16417899 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K200511, K231103. One submission often covers many models, so check the product and lot details in each record.
- Z-0118-2022 · Sep 22, 2021 · Open, ClassifiedROSA One 3.1 Brain application The device is intended for the spatial positioning and orientation of instruments holders or tool guides to be used by trained surgeons to guide s
Other Neurological Stereotaxic Instrument devices
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- StealthStation S8 Platform 9735665Medtronic Navigation, Inc. · Neurological stereotaxic Instrument1 death1,896 reports
- StealthStation S8 9735669Medtronic Navigation, Inc. · Neurological stereotaxic Instrument1,831 reports
- StealthStation S8 Platform 9735665Medtronic Navigation, Inc. · Neurological stereotaxic Instrument2 deaths1,542 reports
- Fusion™ ENT Image Guidance System 9733560XOMMedtronic Navigation, Inc. · Neurological stereotaxic Instrument1,316 reports
- Stealthstation® S7™ 9733858Medtronic Navigation, Inc. · Neurological stereotaxic Instrument8 deaths984 reports
- Stealthstation® S7™ 9733858Medtronic Navigation, Inc. · Neurological stereotaxic Instrument1 death695 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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