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Device brand name · Powered laser surgical instrument

Lumenis Moses 200 D\F\L: medical device reports filed with FDA

582 reports name it, 2022–2026. Manufacturer given most often on reports: Lumenis. Product code GEX.

582
device reports naming the brand
0% of all MAUDE reports · about 149 a year
227
reports, 12 months to August 2026
222 in the 12 months before
90.2%
classified as malfunction
78.1% across the product code
0%
classified as death, as reported
0 reports · not verified by FDA

582 medical device reports received by FDA name the brand "Lumenis Moses 200 D\F\L" (powered laser surgical instrument); the manufacturer given most often on reports is Lumenis; received from August 2022 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.

227 reports arrived in the 12 months to August 2026, close to the 222 of 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 (90.2%) and injury (9.8%); 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 break (72.3%), defective device (8.8%) and nonstandard device (7.9%). The patient problems coded most often are burn(s), foreign body in patient and superficial (first degree) burn. 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

01529Sep 2021: 0Oct 2021: 0Nov 2021: 0Dec 2021: 02022Jan 2022: 0Feb 2022: 0Mar 2022: 0Apr 2022: 0May 2022: 0Jun 2022: 0Jul 2022: 0Aug 2022: 1Sep 2022: 2Oct 2022: 3Nov 2022: 3Dec 2022: 22023Jan 2023: 3Feb 2023: 6Mar 2023: 8Apr 2023: 3May 2023: 6Jun 2023: 2Jul 2023: 3Aug 2023: 7Sep 2023: 9Oct 2023: 9Nov 2023: 7Dec 2023: 72024Jan 2024: 3Feb 2024: 4Mar 2024: 5Apr 2024: 4May 2024: 12Jun 2024: 7Jul 2024: 6Aug 2024: 11Sep 2024: 10Oct 2024: 9Nov 2024: 13Dec 2024: 92025Jan 2025: 7Feb 2025: 29Mar 2025: 27Apr 2025: 21May 2025: 21Jun 2025: 20Jul 2025: 27Aug 2025: 29Sep 2025: 25Oct 2025: 28Nov 2025: 26Dec 2025: 192026Jan 2026: 9Feb 2026: 13Mar 2026: 15Apr 2026: 18May 2026: 11Jun 2026: 20Jul 2026: 22Aug 2026: 21

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

01402792022: 1120222023: 7020232024: 9320242025: 27920252026: 1292026

Event type and report source

Event type, as classified on the report

Death0%0
Injury9.8%57
Malfunction90.2%525
Other0%0
Not given0%0

Who filed the report

Manufacturer report100%582
Voluntary report0%0
User facility report0%0
Distributor report0%0
Not given0%0

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)ReportsShareShare across product code
Breakthe device broke42172.3%18.9%
Defective devicethe device was defective518.8%2.1%
Nonstandard device467.9%1%
Material integrity problema problem with the device material295%0.9%
Power problem274.6%0.8%
Connection problema connection problem91.5%0.7%
Separation problem81.4%0.1%
Firing problem71.2%1.7%
Device displays incorrect message40.7%3.4%
Overheating of device40.7%1.6%
Melted30.5%0.9%
Smoking30.5%0.9%
Device contaminated during manufacture or shipping20.3%0.2%
Device damaged prior to usethe device was damaged before use20.3%0.3%
Device handling problem20.3%0.1%
Gas output problem20.3%0.3%
Material separation20.3%0.3%
Thermal decomposition of device20.3%1.7%
Communication or transmission problemthe device could not communicate or transmit10.2%0.5%
Crackthe device cracked10.2%0.6%

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)ReportsShare
Burn(s)a burn528.9%
Foreign body in patientpart of a device left in the patient40.7%
Superficial (first degree) burn30.5%
Fever10.2%
Painpain, site not specified10.2%
Renal failurekidney failure10.2%
Skin inflammation/ irritation10.2%

Patient problem codes are present mainly in reports filed since 2019 and are often blank.

In context

MeasureLumenis Moses 200 D\F\LProduct code GEXAll MAUDE reports
Reports58244,28326,136,888
Share of that pool—1.3%0%
Classified as death, per 1,000 reports029
Classified as injury9.8%20%36.2%
Classified as malfunction90.2%78.1%62.3%
Filed by the manufacturer100%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

BrandReportsLatest 12 monthsClassified as death
Greenlight Moxy Fiber Optic9,05900%
WaveLight FS200 Femtosecond Laser4,6534860%
Greenlight Addstat3,38900%
FS Disposable Interface1,4421160%
Greenlight Hps Bph Fiber Optic90600%
Flexiva Tm Tractip High Power Single-Use Laser Fiber62700%
Greenlight Xps Laser System62200.2%
Flexiva Tm High Power Single-Use Laser Fiber56500.2%
Visualase595480.8%
Neuroblate System553124%
SOLTIVE Premium SuperPulsed Laser System5221170%
Moxy5112760%
Moses Pulse4771430%
Angled Delivery Device Greenlight46500%
SlimLine SIS EZ4651390%

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 Lumenis Moses 200 D\F\L reports

How many FDA reports name Lumenis Moses 200 D\F\L?

582 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 227 in the latest 12 months.

What kinds of events are reported?

malfunction (90.2%) and injury (9.8%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

break (72.3%), defective device (8.8%), nonstandard device (7.9%), material integrity problem (5%) and power problem (4.6%). 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 Lumenis Moses 200 D\F\L 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.