Devices › Powered laser surgical instrument
Device brand name · Powered laser surgical instrument
SOLTIVE Premium SuperPulsed Laser System: medical device reports filed with FDA
522 reports name it, 2020–2026. Manufacturer given most often on reports: Gyrus Acmi. Product code GEX.
- 522
- device reports naming the brand
- 0% of all MAUDE reports · about 81 a year
- 117
- reports, 12 months to August 2026
- 130 in the 12 months before
- 84.9%
- classified as malfunction
- 78.1% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
522 medical device reports received by FDA name the brand "SOLTIVE Premium SuperPulsed Laser System" (powered laser surgical instrument); the manufacturer given most often on reports is Gyrus Acmi; received from February 2020 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
117 reports arrived in the 12 months to August 2026, down 10% from 130 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 (84.9%) and injury (15.1%); 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 fire (16.5%), communication or transmission problem (11.7%) and smoking (9.6%). The patient problems coded most often are stenosis, urethral stenosis/stricture and appropriate clinical signs, symptoms and conditions term/code not available. 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 |
|---|---|---|---|
| Fire | 86 | 16.5% | 0.8% |
| Communication or transmission problemthe device could not communicate or transmit | 61 | 11.7% | 0.5% |
| Smoking | 50 | 9.6% | 0.9% |
| Breakthe device broke | 39 | 7.5% | 18.9% |
| Connection problema connection problem | 35 | 6.7% | 0.7% |
| Sparking | 28 | 5.4% | 0.3% |
| Output problem | 25 | 4.8% | 1.7% |
| Wireless communication problema wireless connection problem | 16 | 3.1% | 0.1% |
| Computer software problema software problem | 15 | 2.9% | 0.4% |
| Unexpected shutdown | 12 | 2.3% | 0.2% |
| Failure to power up | 11 | 2.1% | 0.4% |
| Flare or flash | 11 | 2.1% | 0.3% |
| Thermal decomposition of device | 11 | 2.1% | 1.7% |
| Melted | 10 | 1.9% | 0.9% |
| Overheating of device | 10 | 1.9% | 1.6% |
| Insufficient device problem information | 8 | 1.5% | 2.7% |
| Device emits odor | 7 | 1.3% | 0.1% |
| Electrical /electronic property probleman electrical or electronic problem | 7 | 1.3% | 0.3% |
| Installation-related problem | 6 | 1.1% | 0% |
| Mechanical problema mechanical problem | 6 | 1.1% | 0.8% |
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 |
|---|---|---|
| Stenosis | 18 | 3.4% |
| Urethral stenosis/stricture | 11 | 2.1% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 8 | 1.5% |
| Renal failurekidney failure | 7 | 1.3% |
| Burn(s)a burn | 6 | 1.1% |
| Kidney infection | 3 | 0.6% |
| Foreign body in patientpart of a device left in the patient | 2 | 0.4% |
| Perforation | 2 | 0.4% |
| Renal impairmentreduced kidney function | 2 | 0.4% |
| Deliriumsudden confusion | 1 | 0.2% |
| Hematuria | 1 | 0.2% |
| Hemorrhage/blood loss/bleeding | 1 | 0.2% |
| Internal organ perforation | 1 | 0.2% |
| Laceration(s) | 1 | 0.2% |
| Obstruction/occlusion | 1 | 0.2% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | SOLTIVE Premium SuperPulsed Laser System | Product code GEX | All MAUDE reports |
|---|---|---|---|
| Reports | 522 | 44,283 | 26,136,888 |
| Share of that pool | — | 1.2% | 0% |
| Classified as death, per 1,000 reports | 0 | 2 | 9 |
| Classified as injury | 15.1% | 20% | 36.2% |
| Classified as malfunction | 84.9% | 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% |
| Visualase | 595 | 48 | 0.8% |
| Neuroblate System | 553 | 12 | 4% |
| 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 SOLTIVE Premium SuperPulsed Laser System reports
How many FDA reports name SOLTIVE Premium SuperPulsed Laser System?
522 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 117 in the latest 12 months.
What kinds of events are reported?
malfunction (84.9%) and injury (15.1%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
fire (16.5%), communication or transmission problem (11.7%), smoking (9.6%), break (7.5%) and connection problem (6.7%). 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 SOLTIVE Premium SuperPulsed Laser System 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.