Ear, nose, and throat stereotaxic instrument: medical device reports filed with FDA

1,738 reports carry this product code, 2014–2026; 19 brands with a page.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "Although MDRs are a valuable source of information, this passive surveillance system has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting of events and lack of information about frequency of device use." And: "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."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

1,738
reports with this product code: 0% of all MAUDE reports; 128
reports, 12 months to August 2026: 284 in the 12 months before; 96.4%
classified as malfunction: 62.3% across all reports; 0.1%
classified as death, as reported: 0.9% across all reports

Product code PGW is FDA's classification for "Ear, nose, and throat stereotaxic instrument" (neurology panel), a class 2 device. 1,738 medical device reports carry this product code, 0% of the MAUDE database, from August 2014 to August 2026.

128 reports arrived in the 12 months to August 2026, down 55% from 284 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 (96.4%), injury (3.5%) and death (0.1%). 19 brand names with a page on this site carry this code; the brands table is 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."

Brands with this product code

Brand	Reports	Latest 12 months	Classified as death	Classified as malfunction
StealthStation FlexENT	581	55	0%	98.6%
Fusion Compact	336	7	0%	98.2%
Fusion Ent Navigation System	77	8	0%	98.8%
StealthStation S8 system	53	1,368	0.1%	97.7%
Stealthstation S8 Em Ent System	44	0	0%	97.7%
Stealthstation S7 System	12	0	0.4%	90.3%
Stealthstation S8 Premium System	9	0	0%	96.1%
Fusion Navigation System	5	0	0%	97.5%
Patient Tracker 9734887xom Non-Invasive	5	7	0%	98.2%
Cart 9733856 S7 Staff Assembled 110v	3	0	0%	96.6%
S8 Premium	3	0	0%	97.8%
Stealthstation	2	0	0%	97.9%
Stealthstation S7	2	30	0.4%	95.7%
Cart 9734056 S7 Staff Shrt 100-120v Intl	1	4	0%	95.1%
Carto 3 System	1	23	0.8%	91.7%
Medtronic Navigation	1	69	6.7%	30.4%
Stealth S8 Premium	1	0	0.5%	98.9%
Stealthstation I7 Integrated Navigation System	1	0	0%	95.8%
Stealthstation S7 Navigation	1	1	0%	95.4%

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."

Manufacturers named

Manufacturer (as written on reports)	Reports	Share
Medtronic Navigation	1,305	75.1%
Medtronic Navigation Louisville	101	5.8%
Stryker Leibinger Freiburg	21	1.2%
Biosense Webster	17	1%
Medtronic Navigation Littleton	4	0.2%

Reports by month, five years

FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.

Event type and report source

Event type

Death0.1%1

Injury3.5%61

Malfunction96.4%1,676

Other0%0

Not given0%0

Who filed

Manufacturer report99.6%1,731

Voluntary report0.1%1

User facility report0%0

Distributor report0.2%4

Not given0.1%2

Grey bar: all 26,136,888 MAUDE reports.

Device problems coded

Device problem (FDA code)	Reports	Share
Application program freezes or fails to launch	266	15.3%
Human-device interface problem	207	11.9%
Imprecision	184	10.6%
Display or visual feedback problem	178	10.2%
Device sensing problem	177	10.2%
Incorrect interpretation of signal	132	7.6%
Communication or transmission problemthe device could not communicate or transmit	128	7.4%
Mechanical problema mechanical problem	119	6.8%
Incorrect, inadequate or imprecise result or readings	117	6.7%
Application program problem	116	6.7%
Material integrity problema problem with the device material	69	4%
Incorrect measurementthe device measured wrongly	60	3.5%
Environmental compatibility problem	58	3.3%
Connection problema connection problem	53	3%
Device operates differently than expectedthe device behaved unexpectedly	44	2.5%
Computer software problema software problem	43	2.5%
Output problem	35	2%
Detachment of device or device componentpart of the device came off	26	1.5%
Device stops intermittentlythe device stopped now and then	23	1.3%
Patient device interaction problem	23	1.3%

Questions about ear, nose, and throat stereotaxic instrument reports

What is product code PGW?

FDA's classification code for "Ear, nose, and throat stereotaxic instrument", class 2, reviewed by the neurology panel. Every device report carries the product code of the device involved.

How many reports carry this code?

1,738 reports through August 2026, 128 of them in the latest 12 months.

Which brands appear most often?

StealthStation FlexENT (581), Fusion Compact (336), Fusion Ent Navigation System (77), StealthStation S8 system (53) and Stealthstation S8 Em Ent System (44). Widely used products collect more reports because more people use them.

Can the brands table be used to rank the devices?

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." Brands differ in how many are in use, how long they have been sold and how reports are collected.

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. 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.