Devices › Device, thermal ablation, endometrial
Device brand name · Device thermal ablation endometrial
Genesys Hta Procerva: medical device reports filed with FDA
400 reports name it, 2012–2020. Manufacturer given most often on reports: Boston Scientific - Spencer. Product code MNB.
- 400
- device reports naming the brand
- 0% of all MAUDE reports · about 28 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 34.3%
- classified as malfunction
- 30.8% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
400 medical device reports received by FDA name the brand "Genesys Hta Procerva" (device thermal ablation endometrial); the manufacturer given most often on reports is Boston Scientific - Spencer; received from April 2012 to November 2020. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
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 (65.5%) and malfunction (34.3%); 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 fluid/blood leak (43.5%), break (7%) and device alarm system (4.8%). The patient problems coded most often are burn(s), uterine 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 Genesys Hta Procerva 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 |
|---|---|---|---|
| Fluid/blood leak | 174 | 43.5% | 7.1% |
| Breakthe device broke | 28 | 7% | 0.8% |
| Device alarm system | 19 | 4.8% | 0.7% |
| Device contamination with chemical or other material | 18 | 4.5% | 0.3% |
| Leak/splashthe device leaked | 17 | 4.3% | 4.4% |
| Device displays incorrect message | 13 | 3.3% | 2.8% |
| Material puncture/hole | 11 | 2.8% | 3.5% |
| Hole in material | 10 | 2.5% | 0.4% |
| Defective devicethe device was defective | 7 | 1.8% | 0.7% |
| Device operates differently than expectedthe device behaved unexpectedly | 6 | 1.5% | 3.8% |
| Material integrity problema problem with the device material | 6 | 1.5% | 0.1% |
| Bent | 4 | 1% | 0.1% |
| Crackthe device cracked | 4 | 1% | 0.5% |
| Detachment of device component | 3 | 0.8% | 0.3% |
| Loss of powerthe device lost power | 3 | 0.8% | 1.2% |
| Temperature problem | 3 | 0.8% | 0.2% |
| Device packaging compromised | 2 | 0.5% | 0% |
| Material deformation | 2 | 0.5% | 1% |
| Component falling | 1 | 0.3% | 0% |
| Component missing | 1 | 0.3% | 0% |
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 |
|---|---|---|
| Burn(s)a burn | 220 | 55% |
| Uterine perforationa hole in the wall of the womb | 14 | 3.5% |
| Painpain, site not specified | 13 | 3.3% |
| Fever | 8 | 2% |
| Abdominal painstomach or belly pain | 6 | 1.5% |
| Perforation | 5 | 1.3% |
| Injurya physical injury | 4 | 1% |
| Vomitingbeing sick | 4 | 1% |
| Abdominal cramps | 3 | 0.8% |
| Nauseafeeling sick | 3 | 0.8% |
| Abscessa collection of pus | 2 | 0.5% |
| Blood loss | 2 | 0.5% |
| Cramp(s) | 2 | 0.5% |
| Full thickness (third degree) burn | 2 | 0.5% |
| No patient involvement | 2 | 0.5% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Genesys Hta Procerva | Product code MNB | All MAUDE reports |
|---|---|---|---|
| Reports | 400 | 6,321 | 26,136,888 |
| Share of that pool | — | 6.3% | 0% |
| Classified as death, per 1,000 reports | 0 | 3 | 9 |
| Classified as injury | 65.5% | 66.7% | 36.2% |
| Classified as malfunction | 34.3% | 30.8% | 62.3% |
| Filed by the manufacturer | 96.8% | 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% |
| Novasure | 1,050 | 140 | 0.4% |
| 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 Genesys Hta Procerva reports
How many FDA reports name Genesys Hta Procerva?
400 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 (65.5%) and malfunction (34.3%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
fluid/blood leak (43.5%), break (7%), device alarm system (4.8%), device contamination with chemical or other material (4.5%) and leak/splash (4.3%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (96.8%) and voluntary reports (0.8%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Genesys Hta Procerva 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.