Devices › Ear, nose, and throat stereotaxic instrument
Device brand name · Ear nose and throat stereotaxic instrument
StealthStation FlexENT: medical device reports filed with FDA
585 reports name it, 2020–2026. Manufacturer given most often on reports: Medtronic Navigation. Product code PGW.
- 585
- device reports naming the brand
- 0% of all MAUDE reports · about 100 a year
- 55
- reports, 12 months to August 2026
- 174 in the 12 months before
- 98.6%
- classified as malfunction
- 96.4% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
FDA's MAUDE database holds 585 reports that name the brand "StealthStation FlexENT" (ear nose and throat stereotaxic instrument), received between September 2020 and August 2026; the manufacturer given most often on reports is Medtronic Navigation. Spellings of one product vary from report to report.
55 reports arrived in the 12 months to August 2026, down 68% from 174 in the 12 months before. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases. The event types recorded are malfunction (98.6%) and injury (1.4%); across all ear, nose, and throat stereotaxic instrument reports (product code PGW) death is recorded in 0.1% and malfunction in 96.4%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are application program freezes or fails to launch (32.3%), display or visual feedback problem (20.3%) and application program problem (17.4%). The patient problems coded most often are cerebrospinal fluid leakage, headache and alteration in body temperature. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Reports by month, five years
Reports by the month FDA received them. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 1,738 reports carrying product code PGW. Event type is the filer's classification and is not verified by FDA.
Device problems coded
| Device problem (FDA code) | Reports | Share | Share across product code |
|---|---|---|---|
| Application program freezes or fails to launch | 189 | 32.3% | 15.3% |
| Display or visual feedback problem | 119 | 20.3% | 10.2% |
| Application program problem | 102 | 17.4% | 6.7% |
| Incorrect, inadequate or imprecise result or readings | 96 | 16.4% | 6.7% |
| Device sensing problem | 68 | 11.6% | 10.2% |
| Human-device interface problem | 54 | 9.2% | 11.9% |
| Communication or transmission problemthe device could not communicate or transmit | 50 | 8.5% | 7.4% |
| Mechanical problema mechanical problem | 31 | 5.3% | 6.8% |
| Imprecision | 27 | 4.6% | 10.6% |
| Computer software problema software problem | 22 | 3.8% | 2.5% |
| Environmental compatibility problem | 21 | 3.6% | 3.3% |
| Unintended application program shut down | 20 | 3.4% | 1.2% |
| Material integrity problema problem with the device material | 15 | 2.6% | 4% |
| No device output | 12 | 2.1% | 0.9% |
| Audible prompt/feedback problem | 11 | 1.9% | 0.7% |
| Connection problema connection problem | 9 | 1.5% | 3% |
| Unexpected shutdown | 9 | 1.5% | 0.8% |
| Electrical /electronic property probleman electrical or electronic problem | 6 | 1% | 0.6% |
| Electromagnetic interference | 3 | 0.5% | 0.3% |
| Failure to read input signal | 3 | 0.5% | 0.2% |
FDA's device problem codes as entered on the report; one report can carry several. Generic codes such as "no apparent adverse event" are left out.
Patient problems coded
| Patient problem (FDA code) | Reports | Share |
|---|---|---|
| Cerebrospinal fluid leakage | 6 | 1% |
| Headachehead pain | 2 | 0.3% |
| Alteration in body temperature | 1 | 0.2% |
| Ambulation or postural difficulties | 1 | 0.2% |
| Anaphylactic shocka severe allergic reaction with collapse | 1 | 0.2% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 1 | 0.2% |
| Bacterial infectiona bacterial infection | 1 | 0.2% |
| Burning sensationa burning feeling | 1 | 0.2% |
| Calcium deposits/calcification | 1 | 0.2% |
| Cardiac arrestthe heart stopped | 1 | 0.2% |
| Discomfortdiscomfort | 1 | 0.2% |
| Electric shockan electric shock | 1 | 0.2% |
| Fatiguetiredness | 1 | 0.2% |
| Hematomaa collection of blood under the skin or in tissue | 1 | 0.2% |
| Hypoventilation | 1 | 0.2% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | StealthStation FlexENT | Product code PGW | All MAUDE reports |
|---|---|---|---|
| Reports | 585 | 1,738 | 26,136,888 |
| Share of that pool | — | 33.7% | 0% |
| Classified as death, per 1,000 reports | 0 | 1 | 9 |
| Classified as injury | 1.4% | 3.5% | 36.2% |
| Classified as malfunction | 98.6% | 96.4% | 62.3% |
| Filed by the manufacturer | 100% | 99.6% | 94.9% |
Shares are of reports, not of devices in use. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Other brands with product code PGW
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Fusion Compact | 339 | 7 | 0% |
| Fusion Ent Navigation System | 1,520 | 8 | 0% |
| StealthStation S8 system | 10,870 | 1,368 | 0.1% |
| Stealthstation S8 Em Ent System | 345 | 0 | 0% |
| Stealthstation S7 System | 5,989 | 0 | 0.4% |
| Stealthstation S8 Premium System | 1,007 | 0 | 0% |
| Fusion Navigation System | 2,165 | 0 | 0% |
| Patient Tracker 9734887xom Non-Invasive | 171 | 7 | 0% |
| Cart 9733856 S7 Staff Assembled 110v | 295 | 0 | 0% |
| S8 Premium | 273 | 0 | 0% |
| Stealthstation | 281 | 0 | 0% |
| Stealthstation S7 | 2,207 | 30 | 0.4% |
| Cart 9734056 S7 Staff Shrt 100-120v Intl | 904 | 4 | 0% |
| Carto 3 System | 996 | 23 | 0.8% |
| Medtronic Navigation | 682 | 69 | 6.7% |
Ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA also states that "common products may have a higher number of adverse events due to the higher total number of people using the product."
Questions about StealthStation FlexENT reports
How many FDA reports name StealthStation FlexENT?
585 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 55 in the latest 12 months.
What kinds of events are reported?
malfunction (98.6%) and injury (1.4%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
application program freezes or fails to launch (32.3%), display or visual feedback problem (20.3%), application program problem (17.4%), incorrect, inadequate or imprecise result or readings (16.4%) and device sensing problem (11.6%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (100%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that StealthStation FlexENT was at fault?
No. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA adds that "a causal relationship cannot be established between product and reactions listed in a report."
How do I report a problem with a medical device?
Through FDA MedWatch (Form FDA 3500 for health professionals and consumers), or to the manufacturer. See the guide on how to report.
Where this comes from. Counts are built from the openFDA Device Adverse Event (MAUDE) bulk export released 28 Sep 2026, which holds reports FDA received through 31 Aug 2026. Brand, generic and manufacturer names are as written on the reports; product code names come from FDA's device classification. A report counts here when any device it lists carries this brand name after punctuation and capitalisation are normalised. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.