Devices › Device, thermal ablation, endometrial
Device brand name · Uterine ablation device
Novasure Impedance Controlled Ea System: medical device reports filed with FDA
1,941 reports name it, 2006–2020. Manufacturer given most often on reports: Hologic. Product code MNB.
- 1,941
- device reports naming the brand
- 0% of all MAUDE reports · about 95 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 3.1%
- classified as malfunction
- 30.8% across the product code
- 0.4%
- classified as death, as reported
- 7 reports · not verified by FDA
FDA's MAUDE database holds 1,941 reports that name the brand "Novasure Impedance Controlled Ea System" (uterine ablation device), received between March 2006 and November 2020; the manufacturer given most often on reports is Hologic. Spellings of one product vary from report to report.
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 injury (94.8%), malfunction (3.1%) and other (1.2%); 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 insufficient device problem information (15.6%), device handling problem (13.5%) and device operates differently than expected (2.9%). The patient problems coded most often are uterine perforation, perforation and pain. 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 Novasure Impedance Controlled Ea System was received in the five years to August 2026; the latest was received in November 2020.
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 |
|---|---|---|---|
| Insufficient device problem information | 303 | 15.6% | 7.2% |
| Device handling problem | 263 | 13.5% | 4.3% |
| Device operates differently than expectedthe device behaved unexpectedly | 56 | 2.9% | 3.8% |
| Device, removal of (non-implant) | 19 | 1% | 0.3% |
| Alarm, audible | 18 | 0.9% | 0.8% |
| Material deformation | 17 | 0.9% | 1% |
| Positioning problem | 16 | 0.8% | 0.3% |
| Replace | 15 | 0.8% | 1.6% |
| Improper or incorrect procedure or method | 12 | 0.6% | 0.4% |
| Difficult to position | 11 | 0.6% | 0.2% |
| Device issuea problem with the device | 10 | 0.5% | 1.2% |
| Detachment of device component | 9 | 0.5% | 0.3% |
| Difficult to insertthe device was hard to insert | 8 | 0.4% | 0.2% |
| Device displays incorrect message | 7 | 0.4% | 2.8% |
| Material puncture/hole | 7 | 0.4% | 3.5% |
| Retraction problem | 7 | 0.4% | 0.5% |
| Therapeutic or diagnostic output failure | 7 | 0.4% | 0.6% |
| Noise, audible | 5 | 0.3% | 0.1% |
| Sticking | 5 | 0.3% | 0.3% |
| Material fragmentation | 4 | 0.2% | 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 | 881 | 45.4% |
| Perforation | 209 | 10.8% |
| Painpain, site not specified | 196 | 10.1% |
| Abdominal painstomach or belly pain | 185 | 9.5% |
| Burn, thermal | 154 | 7.9% |
| Fever | 137 | 7.1% |
| Bowel burn | 116 | 6% |
| Bacterial infectiona bacterial infection | 89 | 4.6% |
| Therapy/non-surgical treatment, additional | 85 | 4.4% |
| Hospitalization required | 78 | 4% |
| Bowel perforation | 66 | 3.4% |
| Sepsisa severe body-wide response to infection | 54 | 2.8% |
| Treatment with medication(s) | 46 | 2.4% |
| Vaso-vagal response | 42 | 2.2% |
| Improved patient condition | 38 | 2% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Novasure Impedance Controlled Ea System | Product code MNB | All MAUDE reports |
|---|---|---|---|
| Reports | 1,941 | 6,321 | 26,136,888 |
| Share of that pool | — | 30.7% | 0% |
| Classified as death, per 1,000 reports | 4 | 3 | 9 |
| Classified as injury | 94.8% | 66.7% | 36.2% |
| Classified as malfunction | 3.1% | 30.8% | 62.3% |
| Filed by the manufacturer | 100% | 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 | 1,050 | 140 | 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 Impedance Controlled Ea System reports
How many FDA reports name Novasure Impedance Controlled Ea System?
1,941 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?
injury (94.8%), malfunction (3.1%) and other (1.2%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
insufficient device problem information (15.6%), device handling problem (13.5%), device operates differently than expected (2.9%), device, removal of (non-implant) (1%) and alarm, audible (0.9%). 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 Novasure Impedance Controlled Ea System 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.