Devices › Powered laser surgical instrument
Device brand name · Powered laser surgical instrument
Greenlight Hps Laser System: medical device reports filed with FDA
267 reports name it, 2010–2025. Manufacturer given most often on reports: American Medical Systems San Jose. Product code GEX.
- 267
- device reports naming the brand
- 0% of all MAUDE reports · about 17 a year
- 1
- reports, 12 months to August 2026
- 8 in the 12 months before
- 58.8%
- classified as malfunction
- 78.1% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
267 medical device reports received by FDA name the brand "Greenlight Hps Laser System" (powered laser surgical instrument); the manufacturer given most often on reports is American Medical Systems San Jose; received from December 2010 to September 2025. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
1 reports arrived in the 12 months to August 2026, down 87% from 8 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 (58.8%) and injury (41.2%); 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 device displays incorrect message (53.9%), device inoperable (19.5%) and device operates differently than expected (16.9%). The patient problems coded most often are ambulation or postural difficulties, injury and fever. 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 |
|---|---|---|---|
| Device displays incorrect message | 144 | 53.9% | 3.4% |
| Device inoperablethe device could not be used | 52 | 19.5% | 1.4% |
| Device operates differently than expectedthe device behaved unexpectedly | 45 | 16.9% | 3.6% |
| No display/image | 16 | 6% | 0.3% |
| Breakthe device broke | 8 | 3% | 18.9% |
| Failure to power up | 7 | 2.6% | 0.4% |
| Fluid/blood leak | 5 | 1.9% | 0.2% |
| Optical problem | 5 | 1.9% | 0.3% |
| Leak/splashthe device leaked | 4 | 1.5% | 0.3% |
| Loss of powerthe device lost power | 4 | 1.5% | 0.3% |
| Visual prompts will not clear | 4 | 1.5% | 0% |
| Electrical /electronic property probleman electrical or electronic problem | 3 | 1.1% | 0.3% |
| Issue with displayed error message | 3 | 1.1% | 0% |
| Output problem | 3 | 1.1% | 1.7% |
| Application interface becomes non-functional or program exits abnormally | 2 | 0.7% | 0% |
| Connection problema connection problem | 2 | 0.7% | 0.7% |
| Excessive cooling | 2 | 0.7% | 0% |
| Extrusion | 2 | 0.7% | 0% |
| Insufficient device problem information | 2 | 0.7% | 2.7% |
| Temperature problem | 2 | 0.7% | 9.3% |
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 |
|---|---|---|
| Ambulation or postural difficulties | 2 | 0.7% |
| Injurya physical injury | 2 | 0.7% |
| Fever | 1 | 0.4% |
| Fistula | 1 | 0.4% |
| Hematuria | 1 | 0.4% |
| Incontinence | 1 | 0.4% |
| Inflammationinflammation | 1 | 0.4% |
| No patient involvement | 1 | 0.4% |
| Painpain, site not specified | 1 | 0.4% |
| Perforation | 1 | 0.4% |
| Swellingswelling | 1 | 0.4% |
| Therapeutic response, decreased | 1 | 0.4% |
| Tissue damage | 1 | 0.4% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Greenlight Hps Laser System | Product code GEX | All MAUDE reports |
|---|---|---|---|
| Reports | 267 | 44,283 | 26,136,888 |
| Share of that pool | — | 0.6% | 0% |
| Classified as death, per 1,000 reports | 0 | 2 | 9 |
| Classified as injury | 41.2% | 20% | 36.2% |
| Classified as malfunction | 58.8% | 78.1% | 62.3% |
| Filed by the manufacturer | 99.6% | 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% |
| SOLTIVE Premium SuperPulsed Laser System | 522 | 117 | 0% |
| Moxy | 511 | 276 | 0% |
| Moses Pulse | 477 | 143 | 0% |
| Angled Delivery Device Greenlight | 465 | 0 | 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 Greenlight Hps Laser System reports
How many FDA reports name Greenlight Hps Laser System?
267 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 1 in the latest 12 months.
What kinds of events are reported?
malfunction (58.8%) and injury (41.2%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
device displays incorrect message (53.9%), device inoperable (19.5%), device operates differently than expected (16.9%), no display/image (6%) and break (3%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.6%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Greenlight Hps 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.