Devices › Electrosurgical, cutting & coagulation & accessories
Device brand name · Powerseal 5mm 37cm curved jaw sealer & divider double-action
Powerseal 5mm 37cm Curved Jaw Sealer & Divider Double-Action: medical device reports filed with FDA
422 reports name it, 2022–2026. Manufacturer given most often on reports: Gyrus Acmi. Product code GEI.
- 422
- device reports naming the brand
- 0% of all MAUDE reports · about 106 a year
- 133
- reports, 12 months to August 2026
- 189 in the 12 months before
- 96.2%
- 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 422 reports that name the brand "Powerseal 5mm 37cm Curved Jaw Sealer & Divider Double-Action" (powerseal 5mm 37cm curved jaw sealer & divider double-action), received between July 2022 and August 2026; the manufacturer given most often on reports is Gyrus Acmi. Spellings of one product vary from report to report.
133 reports arrived in the 12 months to August 2026, down 30% from 189 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 (96.2%) and injury (3.8%); 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 failure to seal (27%), activation failure (16.4%) and communication or transmission problem (6.4%). The patient problems coded most often are hemorrhage/blood loss/bleeding, appropriate clinical signs, symptoms and conditions term/code not available 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 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 |
|---|---|---|---|
| Failure to seal | 114 | 27% | 0.2% |
| Activation failure | 69 | 16.4% | 0.2% |
| Communication or transmission problemthe device could not communicate or transmit | 27 | 6.4% | 1.2% |
| Output problem | 25 | 5.9% | 1.5% |
| Breakthe device broke | 20 | 4.7% | 14% |
| Energy output problem | 20 | 4.7% | 3.6% |
| Physical resistance/sticking | 19 | 4.5% | 0.2% |
| Activation problem | 18 | 4.3% | 0.6% |
| Failure to deliver energy | 16 | 3.8% | 1.3% |
| Mechanical jam | 14 | 3.3% | 0.9% |
| Mechanical problema mechanical problem | 11 | 2.6% | 1.2% |
| Detachment of device or device componentpart of the device came off | 10 | 2.4% | 3.8% |
| Failure to cycle | 7 | 1.7% | 0% |
| Connection problema connection problem | 6 | 1.4% | 0.7% |
| Electrical /electronic property probleman electrical or electronic problem | 6 | 1.4% | 2.7% |
| Failure to cut | 6 | 1.4% | 1.4% |
| Failure to power up | 5 | 1.2% | 0.4% |
| Material twisted/bent | 5 | 1.2% | 1% |
| Electrical shorting | 4 | 0.9% | 0.5% |
| No device output | 4 | 0.9% | 0.2% |
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 |
|---|---|---|
| Hemorrhage/blood loss/bleeding | 4 | 0.9% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 1 | 0.2% |
| Foreign body in patientpart of a device left in the patient | 1 | 0.2% |
| Loss of consciousnesspassing out | 1 | 0.2% |
| Paralysis | 1 | 0.2% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Powerseal 5mm 37cm Curved Jaw Sealer & Divider Double-Action | Product code GEI | All MAUDE reports |
|---|---|---|---|
| Reports | 422 | 118,290 | 26,136,888 |
| Share of that pool | — | 0.4% | 0% |
| Classified as death, per 1,000 reports | 0 | 4 | 9 |
| Classified as injury | 3.8% | 16.7% | 36.2% |
| Classified as malfunction | 96.2% | 80.1% | 62.3% |
| Filed by the manufacturer | 100% | 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 Powerseal 5mm 37cm Curved Jaw Sealer & Divider Double-Action reports
How many FDA reports name Powerseal 5mm 37cm Curved Jaw Sealer & Divider Double-Action?
422 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 133 in the latest 12 months.
What kinds of events are reported?
malfunction (96.2%) and injury (3.8%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
failure to seal (27%), activation failure (16.4%), communication or transmission problem (6.4%), output problem (5.9%) and break (4.7%). 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 Powerseal 5mm 37cm Curved Jaw Sealer & Divider Double-Action 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.