Devices › Electrosurgical, cutting & coagulation & accessories
Device brand name · Ligasure vessel sealing system
Ligasure V 5 Mm Sealer Divider: medical device reports filed with FDA
175 reports name it, 2007–2016. Manufacturer given most often on reports: Covidien Shanghai. Product code GEI.
- 175
- device reports naming the brand
- 0% of all MAUDE reports · about 9 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 87.4%
- classified as malfunction
- 80.1% across the product code
- 1.1%
- classified as death, as reported
- 2 reports · not verified by FDA
175 medical device reports received by FDA name the brand "Ligasure V 5 Mm Sealer Divider" (ligasure vessel sealing system); the manufacturer given most often on reports is Covidien Shanghai; received from January 2007 to December 2016. 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 (87.4%), injury (11.4%) and death (1.1%); 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 (21.7%), device operates differently than expected (18.3%) and detachment of device component (10.9%). The patient problems coded most often are hemorrhage/blood loss/bleeding, tissue damage and failure to anastomose. 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 Ligasure V 5 Mm Sealer Divider was received in the five years to August 2026; the latest was received in December 2016.
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 | 38 | 21.7% | 4.9% |
| Device operates differently than expectedthe device behaved unexpectedly | 32 | 18.3% | 3.9% |
| Detachment of device component | 19 | 10.9% | 3.5% |
| Component falling | 17 | 9.7% | 1.3% |
| Device alarm system | 10 | 5.7% | 0.9% |
| Nonstandard device | 10 | 5.7% | 0.1% |
| Component missing | 9 | 5.1% | 0.5% |
| Loss of or failure to bond | 8 | 4.6% | 0.3% |
| Sticking | 8 | 4.6% | 1.5% |
| Difficult to removethe device was hard to remove | 6 | 3.4% | 0.7% |
| Breakthe device broke | 5 | 2.9% | 14% |
| Failure to adhere or bond | 4 | 2.3% | 0.2% |
| Device slipped | 3 | 1.7% | 0.2% |
| Energy output to patient tissue incorrect | 3 | 1.7% | 0.8% |
| Leak/splashthe device leaked | 3 | 1.7% | 0.4% |
| Mechanical jam | 3 | 1.7% | 0.9% |
| Retraction problem | 3 | 1.7% | 1.2% |
| Insufficient device problem information | 2 | 1.1% | 2.8% |
| Self-activation or keying | 2 | 1.1% | 2.3% |
| Detachment of device or device componentpart of the device came off | 1 | 0.6% | 3.8% |
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 | 22 | 12.6% |
| Tissue damage | 14 | 8% |
| Failure to anastomose | 3 | 1.7% |
| Device embedded in tissue or plaque | 2 | 1.1% |
| Blood loss | 1 | 0.6% |
| Bowel burn | 1 | 0.6% |
| Bowel perforation | 1 | 0.6% |
| Cardiopulmonary arrest | 1 | 0.6% |
| Deaththe patient died; cause not stated by this term | 1 | 0.6% |
| Exsanguination | 1 | 0.6% |
| Foreign body in patientpart of a device left in the patient | 1 | 0.6% |
| Infarction, cerebral | 1 | 0.6% |
| No patient involvement | 1 | 0.6% |
| Pleural effusionfluid around the lung | 1 | 0.6% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Ligasure V 5 Mm Sealer Divider | Product code GEI | All MAUDE reports |
|---|---|---|---|
| Reports | 175 | 118,290 | 26,136,888 |
| Share of that pool | — | 0.1% | 0% |
| Classified as death, per 1,000 reports | 11 | 4 | 9 |
| Classified as injury | 11.4% | 16.7% | 36.2% |
| Classified as malfunction | 87.4% | 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 Ligasure V 5 Mm Sealer Divider reports
How many FDA reports name Ligasure V 5 Mm Sealer Divider?
175 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 (87.4%), injury (11.4%) and death (1.1%). "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 (21.7%), device operates differently than expected (18.3%), detachment of device component (10.9%), component falling (9.7%) and device alarm system (5.7%). 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 Ligasure V 5 Mm Sealer Divider 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.