Light, surgical, ceiling mounted: medical device reports filed with FDA

5,214 reports carry this product code, 1992–2026; 10 brands with a page.

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.

5,214
reports with this product code: 0% of all MAUDE reports; 261
reports, 12 months to August 2026: 353 in the 12 months before; 91.6%
classified as malfunction: 62.3% across all reports; 0%
classified as death, as reported: 0.9% across all reports

Product code FSY is FDA's classification for "Light, surgical, ceiling mounted" (general, Plastic Surgery panel), a class 2 device. 5,214 medical device reports carry this product code, 0% of the MAUDE database, from June 1992 to August 2026.

261 reports arrived in the 12 months to August 2026, down 26% from 353 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 (91.6%), injury (3.1%) and other (3%). 10 brand names with a page on this site carry this code; the brands table is 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."

Brands with this product code

Brand	Reports	Latest 12 months	Classified as death	Classified as malfunction
Powerled	1,325	95	0%	99%
Hled	255	18	0%	98.8%
Volista	227	10	0%	100%
Volista Standop	186	15	0%	99.3%
Xten	168	10	0%	100%
Skytron	30	1	0.9%	50.2%
3612 Lite Glove	2	0	0%	96.3%
3611 Lite Glove	1	0	0.6%	97.1%
Infinity	1	24	2.1%	45.6%
Quantum	1	35	0.5%	66.7%

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."

Manufacturers named

Manufacturer (as written on reports)	Reports	Share
Maquet Sas	3,276	62.8%
Steris - Montgomery	260	5%
Maquet	119	2.3%
Steris	100	1.9%
Hill-Rom	7	0.1%
Deroyal Industries	1	0%
Hill-Rom Batesville	1	0%
Liebel-Flarsheim	1	0%
Maquet Cardiovascular	1	0%
Stryker Medical Division	1	0%
Welch Allyn	1	0%

Reports by month, five years

FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.

Event type and report source

Event type

Death0%0

Injury3.1%160

Malfunction91.6%4,776

Other3%158

Not given2.3%120

Who filed

Manufacturer report95%4,952

Voluntary report1.4%72

User facility report0%0

Distributor report2.1%112

Not given1.5%78

Grey bar: all 26,136,888 MAUDE reports.

Device problems coded

Device problem (FDA code)	Reports	Share
Detachment of device or device componentpart of the device came off	1,593	30.6%
Peeled/delaminated	1,182	22.7%
Component falling	556	10.7%
Crackthe device cracked	427	8.2%
Detachment of device component	416	8%
Corrodedthe device corroded	370	7.1%
Breakthe device broke	298	5.7%
Mechanical problema mechanical problem	196	3.8%
Flaked	186	3.6%
Material integrity problema problem with the device material	155	3%
Degraded	146	2.8%
Material fragmentation	91	1.7%
Material separation	87	1.7%
Device fell	78	1.5%
Fluid/blood leak	65	1.2%
Device operates differently than expectedthe device behaved unexpectedly	62	1.2%
Device dislodged or dislocated	57	1.1%
Other (for use when an appropriate device code cannot be identified)	55	1.1%
Component missing	54	1%
Fracturea broken bone	51	1%

Questions about light, surgical, ceiling mounted reports

What is product code FSY?

FDA's classification code for "Light, surgical, ceiling mounted", class 2, reviewed by the general, Plastic Surgery panel. Every device report carries the product code of the device involved.

How many reports carry this code?

5,214 reports through August 2026, 261 of them in the latest 12 months.

Which brands appear most often?

Powerled (1,325), Hled (255), Volista (227), Volista Standop (186) and Xten (168). Widely used products collect more reports because more people use them.

Can the brands table be used to rank the devices?

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." Brands differ in how many are in use, how long they have been sold and how reports are collected.

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. 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.