Devices › Device, thermal ablation, endometrial
Device brand name · Device thermal ablation endometrial
Novasure: medical device reports filed with FDA
1,050 reports name it, 2003–2026. Manufacturer given most often on reports: Hologic. Product code MNB.
- 1,050
- device reports naming the brand
- 0% of all MAUDE reports · about 45 a year
- 140
- reports, 12 months to August 2026
- 175 in the 12 months before
- 54.8%
- classified as malfunction
- 30.8% across the product code
- 0.4%
- classified as death, as reported
- 4 reports · not verified by FDA
1,050 medical device reports received by FDA name the brand "Novasure" (device thermal ablation endometrial); the manufacturer given most often on reports is Hologic; received from March 2003 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
140 reports arrived in the 12 months to August 2026, down 20% from 175 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 (54.8%), injury (41%) and other (1.5%); across all device, thermal ablation, endometrial reports (product code MNB) death is recorded in 0.3% and malfunction in 30.8%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are material puncture/hole (12%), device operates differently than expected (9.6%) and insufficient device problem information (5.8%). The patient problems coded most often are uterine perforation, pain and foreign body in patient. 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
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
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 6,321 reports carrying product code MNB. 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 |
|---|---|---|---|
| Material puncture/hole | 126 | 12% | 3.5% |
| Device operates differently than expectedthe device behaved unexpectedly | 101 | 9.6% | 3.8% |
| Insufficient device problem information | 61 | 5.8% | 7.2% |
| Replace | 52 | 5% | 1.6% |
| Detachment of device or device componentpart of the device came off | 38 | 3.6% | 0.8% |
| Device displays incorrect message | 36 | 3.4% | 2.8% |
| Device inoperablethe device could not be used | 34 | 3.2% | 0.9% |
| Material deformation | 31 | 3% | 1% |
| Device issuea problem with the device | 27 | 2.6% | 1.2% |
| Difficult to removethe device was hard to remove | 27 | 2.6% | 0.5% |
| Retraction problem | 17 | 1.6% | 0.5% |
| Defective devicethe device was defective | 13 | 1.2% | 0.7% |
| Therapeutic or diagnostic output failure | 12 | 1.1% | 0.6% |
| Difficult to open or close | 11 | 1% | 0.2% |
| Sticking | 10 | 1% | 0.3% |
| Malfunction | 9 | 0.9% | 0.3% |
| Failure to calibrate | 7 | 0.7% | 0% |
| Leak/splashthe device leaked | 7 | 0.7% | 4.4% |
| Melted | 7 | 0.7% | 0.4% |
| Patient-device incompatibilitythe device did not suit the patient | 7 | 0.7% | 0.1% |
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 |
|---|---|---|
| Uterine perforationa hole in the wall of the womb | 178 | 17% |
| Painpain, site not specified | 74 | 7% |
| Foreign body in patientpart of a device left in the patient | 48 | 4.6% |
| Abdominal painstomach or belly pain | 31 | 3% |
| Bowel burn | 26 | 2.5% |
| Hemorrhage/blood loss/bleeding | 25 | 2.4% |
| Burn(s)a burn | 23 | 2.2% |
| Burn, thermal | 16 | 1.5% |
| Bacterial infectiona bacterial infection | 14 | 1.3% |
| Fever | 14 | 1.3% |
| Cramp(s) | 12 | 1.1% |
| Abdominal cramps | 11 | 1% |
| Bowel perforation | 10 | 1% |
| Cardiac arrestthe heart stopped | 10 | 1% |
| Sepsisa severe body-wide response to infection | 10 | 1% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Novasure | Product code MNB | All MAUDE reports |
|---|---|---|---|
| Reports | 1,050 | 6,321 | 26,136,888 |
| Share of that pool | — | 16.6% | 0% |
| Classified as death, per 1,000 reports | 4 | 3 | 9 |
| Classified as injury | 41% | 66.7% | 36.2% |
| Classified as malfunction | 54.8% | 30.8% | 62.3% |
| Filed by the manufacturer | 45.5% | 81% | 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 MNB
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Novasure Impedance Controlled Ea System | 1,941 | 0 | 0.4% |
| Genesys Hta Procerva | 400 | 0 | 0% |
| Hydro Thermablator Hta Endometrial Ablation System | 370 | 0 | 0% |
| Novasure Suresound | 193 | 7 | 0% |
| Hydrothermablator Procedure Set | 182 | 0 | 0% |
| Hyrdothermablator Procedure Set | 154 | 0 | 0% |
| Thermachoice | 717 | 0 | 1.1% |
| Myosure Hysteroscopic Tissue Removal System | 215 | 0 | 1.4% |
| Resolution Clip Device | 1,596 | 0 | 0.3% |
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." 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 Novasure reports
How many FDA reports name Novasure?
1,050 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 140 in the latest 12 months.
What kinds of events are reported?
malfunction (54.8%), injury (41%) and other (1.5%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
material puncture/hole (12%), device operates differently than expected (9.6%), insufficient device problem information (5.8%), replace (5%) and detachment of device or device component (3.6%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (45.5%) and voluntary reports (24%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Novasure 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.