System, ablation, microwave and accessories: medical device reports filed with FDA

1,798 reports carry this product code, 2002–2026; 6 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.

1,798
reports with this product code: 0% of all MAUDE reports; 109
reports, 12 months to August 2026: 134 in the 12 months before; 57.2%
classified as malfunction: 62.3% across all reports; 2.5%
classified as death, as reported: 0.9% across all reports

Product code NEY is FDA's classification for "System, ablation, microwave and accessories" (general, Plastic Surgery panel), a class 2 device. 1,798 medical device reports carry this product code, 0% of the MAUDE database, from March 2002 to August 2026.

109 reports arrived in the 12 months to August 2026, down 19% from 134 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 (57.2%), injury (39.9%) and death (2.5%). 6 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
Emprint	214	39	2.6%	48.8%
Morpheus Picc	10	0	0%	100%
Cool-tip	9	28	2%	78.1%
da Vinci	2	404	1.2%	27.2%
8mm Mcs Tip Cover Accessory	1	0	0%	73.7%
miraDry System	1	46	0.3%	1.7%

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
Angiodynamics	523	29.1%
Covidien Medical Products	194	10.8%
Covidien	139	7.7%
Covidien - Superdimension	132	7.3%
Covidien Shanghai	83	4.6%
Covidien Mfg Dc Boulder	60	3.3%
Covidien Valleylab	49	2.7%
Guidant Cardiac Surgery	23	1.3%
Varian Medical Systems	10	0.6%
Intuitive Surgical	7	0.4%
Biosense Webster	1	0.1%

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

Death2.5%45

Injury39.9%717

Malfunction57.2%1,028

Other0.3%5

Not given0.2%3

Who filed

Manufacturer report94.9%1,706

Voluntary report2.2%39

User facility report0%0

Distributor report0%0

Not given2.9%53

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	276	15.4%
Temperature problem	267	14.8%
Breakthe device broke	200	11.1%
Device displays incorrect message	94	5.2%
Detachment of device component	92	5.1%
Fracturea broken bone	88	4.9%
Bent	54	3%
Insufficient device problem information	53	2.9%
Leak/splashthe device leaked	28	1.6%
Device alarm system	27	1.5%
Device operates differently than expectedthe device behaved unexpectedly	26	1.4%
No flow	25	1.4%
Device inoperablethe device could not be used	15	0.8%
Energy output problem	15	0.8%
Crackthe device cracked	14	0.8%
Failure to fire	14	0.8%
Material twisted/bent	14	0.8%
Activation problem	12	0.7%
Connection problema connection problem	11	0.6%
Gas/air leak	11	0.6%

Questions about system, ablation, microwave and accessories reports

What is product code NEY?

FDA's classification code for "System, ablation, microwave and accessories", 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?

1,798 reports through August 2026, 109 of them in the latest 12 months.

Which brands appear most often?

Emprint (214), Morpheus Picc (10), Cool-tip (9), da Vinci (2) and 8mm Mcs Tip Cover Accessory (1). 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.