Angled Delivery Device Greenlight Xps: medical device reports filed with FDA

395 reports name it, 2012–2012. Manufacturer given most often on reports: American Medical Systems. Product code GEX.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "Although MDRs are a valuable source of information, this passive surveillance system has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting of events and lack of information about frequency of device use." And: "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."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

395
device reports naming the brand: 0% of all MAUDE reports · about 27 a year; 0
reports, 12 months to August 2026: 0 in the 12 months before; 83%
classified as malfunction: 78.1% across the product code; 0%
classified as death, as reported: 0 reports · not verified by FDA

395 medical device reports received by FDA name the brand "Angled Delivery Device Greenlight Xps" (surgical fiber); the manufacturer given most often on reports is American Medical Systems; received from January 2012 to November 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 (83%), injury (16.5%) and other (0.5%); 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 output problem (23.5%), break (19.2%) and failure to align (6.3%). The patient problems coded most often are device embedded in tissue or plaque, blood loss and hemorrhage/blood loss/bleeding. 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 Angled Delivery Device Greenlight Xps was received in the five years to August 2026; the latest was received in November 2012.

Event type and report source

Event type, as classified on the report

Death0%0

Injury16.5%65

Malfunction83%328

Other0.5%2

Not given0%0

Who filed the report

Manufacturer report100%395

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)	Reports	Share	Share across product code
Output problem	93	23.5%	1.7%
Breakthe device broke	76	19.2%	18.9%
Failure to align	25	6.3%	2.9%
Device displays incorrect message	21	5.3%	3.4%
Protective measures problem	17	4.3%	0.2%
Device operates differently than expectedthe device behaved unexpectedly	13	3.3%	3.6%
Material integrity problema problem with the device material	11	2.8%	0.9%
Device inoperablethe device could not be used	7	1.8%	1.4%
Detachment of device component	4	1%	2.4%
Device alarm system	4	1%	0.2%
Unintended movement	3	0.8%	0%
Crackthe device cracked	2	0.5%	0.6%
Fracturea broken bone	2	0.5%	12.8%
Temperature problem	2	0.5%	9.3%
Thermal decomposition of device	2	0.5%	1.7%

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	12	3%
Blood loss	1	0.3%
Hemorrhage/blood loss/bleeding	1	0.3%
Phototoxicity	1	0.3%
Superficial (first degree) burn	1	0.3%

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

In context

Measure	Angled Delivery Device Greenlight Xps	Product code GEX	All MAUDE reports
Reports	395	44,283	26,136,888
Share of that pool	—	0.9%	0%
Classified as death, per 1,000 reports	0	2	9
Classified as injury	16.5%	20%	36.2%
Classified as malfunction	83%	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%
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 Angled Delivery Device Greenlight Xps reports

How many FDA reports name Angled Delivery Device Greenlight Xps?

395 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 (83%), injury (16.5%) and other (0.5%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

output problem (23.5%), break (19.2%), failure to align (6.3%), device displays incorrect message (5.3%) and protective measures problem (4.3%). 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 Angled Delivery Device Greenlight Xps 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.