Devices › Electrosurgical, cutting & coagulation & accessories
Device brand name · Electrosurgical cutting & coagulation & accessories
Enseal: medical device reports filed with FDA
201 reports name it, 2009–2026. Manufacturer given most often on reports: Ethicon Endo-Surgery. Product code GEI.
- 201
- device reports naming the brand
- 0% of all MAUDE reports · about 12 a year
- 55
- reports, 12 months to August 2026
- 4 in the 12 months before
- 90.5%
- classified as malfunction
- 80.1% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
FDA's MAUDE database holds 201 reports that name the brand "Enseal" (electrosurgical cutting & coagulation & accessories), received between November 2009 and August 2026; the manufacturer given most often on reports is Ethicon Endo-Surgery. Spellings of one product vary from report to report.
55 reports arrived in the 12 months to August 2026, up 1275% from 4 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 (90.5%), injury (8.5%) and other (0.5%); across all electrosurgical, cutting & coagulation & accessories reports (product code GEI) death is recorded in 0.4% and malfunction in 80.1%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are difficult to open or close (20.4%), break (14.4%) and detachment of device component (8%). The patient problems coded most often are burn(s), foreign body in patient and hematoma. 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 118,290 reports carrying product code GEI. 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 |
|---|---|---|---|
| Difficult to open or close | 41 | 20.4% | 4.9% |
| Breakthe device broke | 29 | 14.4% | 14% |
| Detachment of device component | 16 | 8% | 3.5% |
| Detachment of device or device componentpart of the device came off | 11 | 5.5% | 3.8% |
| Device displays incorrect message | 9 | 4.5% | 2.9% |
| Device operates differently than expectedthe device behaved unexpectedly | 9 | 4.5% | 3.9% |
| Component falling | 8 | 4% | 1.3% |
| Patient device interaction problem | 7 | 3.5% | 0.2% |
| Mechanical jam | 6 | 3% | 0.9% |
| Sticking | 5 | 2.5% | 1.5% |
| Bent | 4 | 2% | 0.5% |
| Therapeutic or diagnostic output failure | 4 | 2% | 0.3% |
| Device inoperablethe device could not be used | 3 | 1.5% | 1.5% |
| Mechanical problema mechanical problem | 3 | 1.5% | 1.2% |
| Protective measures problem | 3 | 1.5% | 0.6% |
| Defective devicethe device was defective | 2 | 1% | 0.6% |
| Failure to read input signal | 2 | 1% | 0.1% |
| Firing problem | 2 | 1% | 0% |
| Activation, positioning or separation problem | 1 | 0.5% | 0.2% |
| Battery problem: low impedance | 1 | 0.5% | 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 | 4 | 2% |
| Foreign body in patientpart of a device left in the patient | 3 | 1.5% |
| Hematomaa collection of blood under the skin or in tissue | 3 | 1.5% |
| Device embedded in tissue or plaque | 2 | 1% |
| Hemorrhage/blood loss/bleeding | 2 | 1% |
| No patient involvement | 2 | 1% |
| Abscessa collection of pus | 1 | 0.5% |
| Airway obstruction | 1 | 0.5% |
| Low blood pressure/ hypotension | 1 | 0.5% |
| Nerve damage | 1 | 0.5% |
| Post operative wound infection | 1 | 0.5% |
| Tissue damage | 1 | 0.5% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Enseal | Product code GEI | All MAUDE reports |
|---|---|---|---|
| Reports | 201 | 118,290 | 26,136,888 |
| Share of that pool | — | 0.2% | 0% |
| Classified as death, per 1,000 reports | 0 | 4 | 9 |
| Classified as injury | 8.5% | 16.7% | 36.2% |
| Classified as malfunction | 90.5% | 80.1% | 62.3% |
| Filed by the manufacturer | 42.3% | 92.4% | 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 GEI
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| LigaSure | 8,264 | 879 | 0.2% |
| VasoView Hemopro 2 | 6,633 | 686 | 0% |
| THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type S | 4,590 | 403 | 0% |
| HF unit "ESG-400" | 2,698 | 664 | 0.1% |
| Valleylab | 2,010 | 353 | 0.3% |
| Vaso View Hemopro | 1,838 | 0 | 0.1% |
| LigaSure Impact | 1,831 | 72 | 0.3% |
| THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip | 1,505 | 38 | 0.3% |
| Thunderbeat 5mm 35cm Front-Actuated Grip | 1,247 | 0 | 0.2% |
| Valleylab Ft10 | 1,203 | 2 | 0.3% |
| Vasoview Hemopro | 1,187 | 0 | 0% |
| Ligasure Advance Pistol Grip | 970 | 0 | 0% |
| Ligasure Atlas Handswitching 37cm | 924 | 0 | 0.2% |
| Edge | 859 | 171 | 0.1% |
| Force Fx | 780 | 22 | 0.4% |
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 Enseal reports
How many FDA reports name Enseal?
201 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 55 in the latest 12 months.
What kinds of events are reported?
malfunction (90.5%), injury (8.5%) and other (0.5%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
difficult to open or close (20.4%), break (14.4%), detachment of device component (8%), detachment of device or device component (5.5%) and device displays incorrect message (4.5%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (42.3%) and voluntary reports (8.5%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Enseal 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.