Devices › Electrosurgical, cutting & coagulation & accessories
Device brand name · Ligasure vessel sealing system
New Ligasure 5mm: medical device reports filed with FDA
697 reports name it, 2010–2017. Manufacturer given most often on reports: Covidien. Product code GEI.
- 697
- device reports naming the brand
- 0% of all MAUDE reports · about 42 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 94.5%
- classified as malfunction
- 80.1% across the product code
- 0.4%
- classified as death, as reported
- 3 reports · not verified by FDA
697 medical device reports received by FDA name the brand "New Ligasure 5mm" (ligasure vessel sealing system); the manufacturer given most often on reports is Covidien; received from January 2010 to January 2017. 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 malfunction (94.5%), injury (4.6%) and death (0.4%); 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 device operates differently than expected (28.8%), difficult to open or close (24.4%) and self-activation or keying (10.9%). The patient problems coded most often are hemorrhage/blood loss/bleeding, tissue damage and blood loss. 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 New Ligasure 5mm was received in the five years to August 2026; the latest was received in January 2017.
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 |
|---|---|---|---|
| Device operates differently than expectedthe device behaved unexpectedly | 201 | 28.8% | 3.9% |
| Difficult to open or close | 170 | 24.4% | 4.9% |
| Self-activation or keying | 76 | 10.9% | 2.3% |
| Device alarm system | 57 | 8.2% | 0.9% |
| Sticking | 46 | 6.6% | 1.5% |
| Mechanical jam | 34 | 4.9% | 0.9% |
| Difficult to removethe device was hard to remove | 22 | 3.2% | 0.7% |
| Failure to adhere or bond | 20 | 2.9% | 0.2% |
| Nonstandard device | 20 | 2.9% | 0.1% |
| Loss of or failure to bond | 19 | 2.7% | 0.3% |
| Breakthe device broke | 17 | 2.4% | 14% |
| Improper or incorrect procedure or method | 17 | 2.4% | 0.5% |
| Entrapment of device | 16 | 2.3% | 0.3% |
| Insufficient device problem information | 15 | 2.2% | 2.8% |
| Detachment of device component | 14 | 2% | 3.5% |
| Device inoperablethe device could not be used | 12 | 1.7% | 1.5% |
| Leak/splashthe device leaked | 10 | 1.4% | 0.4% |
| Fail-safe problem | 6 | 0.9% | 0% |
| Failure to form staple | 6 | 0.9% | 0.1% |
| Mechanics altered | 6 | 0.9% | 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 |
|---|---|---|
| Hemorrhage/blood loss/bleeding | 185 | 26.5% |
| Tissue damage | 73 | 10.5% |
| Blood loss | 16 | 2.3% |
| Failure to anastomose | 8 | 1.1% |
| Laceration(s) | 6 | 0.9% |
| Burn, thermal | 3 | 0.4% |
| No patient involvement | 3 | 0.4% |
| Burn(s)a burn | 2 | 0.3% |
| Deaththe patient died; cause not stated by this term | 2 | 0.3% |
| Inflammationinflammation | 2 | 0.3% |
| Injurya physical injury | 2 | 0.3% |
| Partial thickness (second degree) burn | 2 | 0.3% |
| Adhesion(s) | 1 | 0.1% |
| Bleeding | 1 | 0.1% |
| Bowel perforation | 1 | 0.1% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | New Ligasure 5mm | Product code GEI | All MAUDE reports |
|---|---|---|---|
| Reports | 697 | 118,290 | 26,136,888 |
| Share of that pool | — | 0.6% | 0% |
| Classified as death, per 1,000 reports | 4 | 4 | 9 |
| Classified as injury | 4.6% | 16.7% | 36.2% |
| Classified as malfunction | 94.5% | 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 New Ligasure 5mm reports
How many FDA reports name New Ligasure 5mm?
697 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?
malfunction (94.5%), injury (4.6%) and death (0.4%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
device operates differently than expected (28.8%), difficult to open or close (24.4%), self-activation or keying (10.9%), device alarm system (8.2%) and sticking (6.6%). 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 New Ligasure 5mm 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.