Devices › Powered laser surgical instrument
Device brand name · Surgical fiber
Greenlight Addstat: medical device reports filed with FDA
3,389 reports name it, 2006–2012. Manufacturer given most often on reports: American Medical Systems Innovation Center - Silicon Valley. Product code GEX.
- 3,389
- device reports naming the brand
- 0% of all MAUDE reports · about 165 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 99.5%
- classified as malfunction
- 78.1% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
3,389 medical device reports received by FDA name the brand "Greenlight Addstat" (surgical fiber); the manufacturer given most often on reports is American Medical Systems Innovation Center - Silicon Valley; received from January 2006 to January 2012. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
0 reports arrived in the 12 months to August 2026, and none 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 (99.5%), injury (0.3%) and other (0.2%); 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 improper device output (23.1%), break (22.3%) and detachment of device component (17.3%). The patient problems coded most often are device embedded in tissue or plaque, hemorrhage/blood loss/bleeding and therapeutic response, decreased. 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
No report naming Greenlight Addstat was received in the five years to August 2026; the latest was received in January 2012.
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 |
|---|---|---|---|
| Improper device output | 784 | 23.1% | 1.9% |
| Breakthe device broke | 757 | 22.3% | 18.9% |
| Detachment of device component | 587 | 17.3% | 2.4% |
| Failure to align | 544 | 16.1% | 2.9% |
| Thermal decomposition of device | 277 | 8.2% | 1.7% |
| Misfire | 254 | 7.5% | 1.2% |
| Device operates differently than expectedthe device behaved unexpectedly | 244 | 7.2% | 3.6% |
| Melted | 158 | 4.7% | 0.9% |
| Naturally worn | 143 | 4.2% | 0.3% |
| Output below specifications | 130 | 3.8% | 1.5% |
| Fracturea broken bone | 82 | 2.4% | 12.8% |
| Flare or flash | 59 | 1.7% | 0.3% |
| Device inoperablethe device could not be used | 54 | 1.6% | 1.4% |
| Detachment of device or device componentpart of the device came off | 52 | 1.5% | 4.1% |
| Burst container or vessel | 46 | 1.4% | 0.2% |
| No device output | 44 | 1.3% | 0.3% |
| Device alarm system | 42 | 1.2% | 0.2% |
| Positioning problem | 27 | 0.8% | 0.1% |
| Hole in material | 23 | 0.7% | 0.1% |
| Device reprocessing problem | 17 | 0.5% | 0.1% |
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 |
|---|---|---|
| Device embedded in tissue or plaque | 8 | 0.2% |
| Hemorrhage/blood loss/bleeding | 7 | 0.2% |
| Therapeutic response, decreased | 6 | 0.2% |
| Injurya physical injury | 3 | 0.1% |
| Foreign body in patientpart of a device left in the patient | 2 | 0.1% |
| Perforation | 2 | 0.1% |
| Abdominal painstomach or belly pain | 1 | 0% |
| Abrasion | 1 | 0% |
| Blood loss | 1 | 0% |
| Hematuria | 1 | 0% |
| Incontinence | 1 | 0% |
| Internal organ perforation | 1 | 0% |
| Muscle spasm(s) | 1 | 0% |
| Necrosisdeath of tissue | 1 | 0% |
| Painpain, site not specified | 1 | 0% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Greenlight Addstat | Product code GEX | All MAUDE reports |
|---|---|---|---|
| Reports | 3,389 | 44,283 | 26,136,888 |
| Share of that pool | — | 7.7% | 0% |
| Classified as death, per 1,000 reports | 0 | 2 | 9 |
| Classified as injury | 0.3% | 20% | 36.2% |
| Classified as malfunction | 99.5% | 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% |
| 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% |
| 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 Greenlight Addstat reports
How many FDA reports name Greenlight Addstat?
3,389 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 0 in the latest 12 months.
What kinds of events are reported?
malfunction (99.5%), injury (0.3%) and other (0.2%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
improper device output (23.1%), break (22.3%), detachment of device component (17.3%), failure to align (16.1%) and thermal decomposition of device (8.2%). 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 Greenlight Addstat 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.