Device, thermal ablation, endometrial: medical device reports filed with FDA

6,321 reports carry this product code, 1997–2026; 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.

6,321
reports with this product code: 0% of all MAUDE reports; 176
reports, 12 months to August 2026: 256 in the 12 months before; 30.8%
classified as malfunction: 62.3% across all reports; 0.3%
classified as death, as reported: 0.9% across all reports

Product code MNB is FDA's classification for "Device, thermal ablation, endometrial" (unknown panel), a class 3 device. 6,321 medical device reports carry this product code, 0% of the MAUDE database, from December 1997 to August 2026.

176 reports arrived in the 12 months to August 2026, down 31% from 256 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 injury (66.7%), malfunction (30.8%) and other (1.4%). 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
Novasure Impedance Controlled Ea System	1,941	0	0.4%	3.1%
Novasure	1,031	140	0.4%	54.8%
Genesys Hta Procerva	400	0	0%	34.3%
Hydro Thermablator Hta Endometrial Ablation System	370	0	0%	51.1%
Novasure Suresound	193	7	0%	30.1%
Hydrothermablator Procedure Set	182	0	0%	19.2%
Hyrdothermablator Procedure Set	154	0	0%	12.3%
Thermachoice	148	0	1.1%	50.9%
Myosure Hysteroscopic Tissue Removal System	1	0	1.4%	15.3%
Resolution Clip Device	1	0	0.3%	90.3%

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
Hologic	3,163	50%
Boston Scientific - Marlborough	699	11.1%
Boston Scientific	326	5.2%
Boston Scientific - Spencer	101	1.6%
Ethicon	56	0.9%
Boston Scientific - Fremont Ce	49	0.8%
Coopersurgical	27	0.4%
American Medical Systems	1	0%
Atricure	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

Death0.3%22

Injury66.7%4,215

Malfunction30.8%1,945

Other1.4%87

Not given0.8%52

Who filed

Manufacturer report81%5,120

Voluntary report9%567

User facility report0%0

Distributor report0%1

Not given10%633

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

Device problems coded

Device problem (FDA code)	Reports	Share
Insufficient device problem information	457	7.2%
Fluid/blood leak	447	7.1%
Leak/splashthe device leaked	277	4.4%
Device handling problem	274	4.3%
Device operates differently than expectedthe device behaved unexpectedly	240	3.8%
Material puncture/hole	223	3.5%
Device displays incorrect message	180	2.8%
Other (for use when an appropriate device code cannot be identified)	124	2%
Replace	104	1.6%
Balloon leak(s)	97	1.5%
Device issuea problem with the device	77	1.2%
Loss of powerthe device lost power	74	1.2%
Material deformation	61	1%
Device inoperablethe device could not be used	56	0.9%
Alarm, audible	53	0.8%
Detachment of device or device componentpart of the device came off	52	0.8%
Breakthe device broke	50	0.8%
Device alarm system	47	0.7%
Decrease in pressure	46	0.7%
Overheating of device	43	0.7%

Questions about device, thermal ablation, endometrial reports

What is product code MNB?

FDA's classification code for "Device, thermal ablation, endometrial", class 3, reviewed by the unknown panel. Every device report carries the product code of the device involved.

How many reports carry this code?

6,321 reports through August 2026, 176 of them in the latest 12 months.

Which brands appear most often?

Novasure Impedance Controlled Ea System (1,941), Novasure (1,031), Genesys Hta Procerva (400), Hydro Thermablator Hta Endometrial Ablation System (370) and Novasure Suresound (193). 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.