Devices › Powered laser surgical instrument
Device brand name · Powered laser surgical instrument
Visualase: medical device reports filed with FDA
595 reports name it, 2018–2026. Manufacturer given most often on reports: Medtronic Navigation. Product code GEX.
- 595
- device reports naming the brand
- 0% of all MAUDE reports · about 78 a year
- 48
- reports, 12 months to August 2026
- 69 in the 12 months before
- 73.8%
- classified as malfunction
- 78.1% across the product code
- 0.8%
- classified as death, as reported
- 5 reports · not verified by FDA
595 medical device reports received by FDA name the brand "Visualase" (powered laser surgical instrument); the manufacturer given most often on reports is Medtronic Navigation; received from November 2018 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
48 reports arrived in the 12 months to August 2026, down 30% from 69 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 (73.8%), injury (25.4%) and death (0.8%); across all powered laser surgical instrument reports (product code GEX) death is recorded in 0.2% and malfunction in 78.1%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are mechanical problem (36.1%), incorrect, inadequate or imprecise result or readings (10.3%) and no device output (6.7%). The patient problems coded most often are visual impairment, no patient involvement and memory loss/impairment. 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 44,283 reports carrying product code GEX. 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 |
|---|---|---|---|
| Mechanical problema mechanical problem | 215 | 36.1% | 0.8% |
| Incorrect, inadequate or imprecise result or readings | 61 | 10.3% | 0.2% |
| No device output | 40 | 6.7% | 0.3% |
| Infusion or flow problema problem with flow or infusion | 34 | 5.7% | 0.2% |
| Insufficient heating | 31 | 5.2% | 0.1% |
| Thermal decomposition of device | 30 | 5% | 1.7% |
| Failure to read input signal | 25 | 4.2% | 0.1% |
| Material fragmentation | 18 | 3% | 0.3% |
| Leak/splashthe device leaked | 17 | 2.9% | 0.3% |
| Breakthe device broke | 12 | 2% | 18.9% |
| Connection problema connection problem | 11 | 1.8% | 0.7% |
| Material integrity problema problem with the device material | 9 | 1.5% | 0.9% |
| No display/image | 9 | 1.5% | 0.3% |
| Energy output problem | 8 | 1.3% | 0.4% |
| Image display error/artifact | 8 | 1.3% | 0% |
| Erratic or intermittent display | 7 | 1.2% | 0% |
| Application program problem | 6 | 1% | 0% |
| Biocompatibility | 6 | 1% | 0% |
| Temperature problem | 5 | 0.8% | 9.3% |
| Unexpected therapeutic results | 5 | 0.8% | 1.1% |
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 |
|---|---|---|
| Visual impairmentreduced vision | 41 | 6.9% |
| No patient involvement | 25 | 4.2% |
| Memory loss/impairment | 19 | 3.2% |
| Intracranial hemorrhage | 13 | 2.2% |
| Muscle weakness/atrophy | 12 | 2% |
| Headachehead pain | 11 | 1.8% |
| Hemorrhage/blood loss/bleeding | 9 | 1.5% |
| Convulsion/seizure | 8 | 1.3% |
| Seizures | 8 | 1.3% |
| Cognitive changes | 7 | 1.2% |
| Dysphasia | 7 | 1.2% |
| Nerve damage | 6 | 1% |
| Swelling/ edema | 6 | 1% |
| Depressionlow mood | 5 | 0.8% |
| Hematomaa collection of blood under the skin or in tissue | 5 | 0.8% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Visualase | Product code GEX | All MAUDE reports |
|---|---|---|---|
| Reports | 595 | 44,283 | 26,136,888 |
| Share of that pool | — | 1.3% | 0% |
| Classified as death, per 1,000 reports | 8 | 2 | 9 |
| Classified as injury | 25.4% | 20% | 36.2% |
| Classified as malfunction | 73.8% | 78.1% | 62.3% |
| Filed by the manufacturer | 100% | 94.9% | 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 GEX
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Greenlight Moxy Fiber Optic | 9,059 | 0 | 0% |
| WaveLight FS200 Femtosecond Laser | 4,653 | 486 | 0% |
| Greenlight Addstat | 3,389 | 0 | 0% |
| FS Disposable Interface | 1,442 | 116 | 0% |
| Greenlight Hps Bph Fiber Optic | 906 | 0 | 0% |
| Flexiva Tm Tractip High Power Single-Use Laser Fiber | 627 | 0 | 0% |
| Greenlight Xps Laser System | 622 | 0 | 0.2% |
| Lumenis Moses 200 D\F\L | 582 | 227 | 0% |
| Flexiva Tm High Power Single-Use Laser Fiber | 565 | 0 | 0.2% |
| Neuroblate System | 553 | 12 | 4% |
| SOLTIVE Premium SuperPulsed Laser System | 522 | 117 | 0% |
| Moxy | 511 | 276 | 0% |
| Moses Pulse | 477 | 143 | 0% |
| Angled Delivery Device Greenlight | 465 | 0 | 0% |
| SlimLine SIS EZ | 465 | 139 | 0% |
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 Visualase reports
How many FDA reports name Visualase?
595 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 48 in the latest 12 months.
What kinds of events are reported?
malfunction (73.8%), injury (25.4%) and death (0.8%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
mechanical problem (36.1%), incorrect, inadequate or imprecise result or readings (10.3%), no device output (6.7%), infusion or flow problem (5.7%) and insufficient heating (5.2%). 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 Visualase 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.