Devices › Electrosurgical, cutting & coagulation & accessories
Device brand name · Electrosurgical cutting & coagulation & accessories
Cool-tip: medical device reports filed with FDA
456 reports name it, 2017–2026. Manufacturer given most often on reports: Covidien Mfg Dc Boulder. Product code GEI.
- 456
- device reports naming the brand
- 0% of all MAUDE reports · about 48 a year
- 28
- reports, 12 months to August 2026
- 25 in the 12 months before
- 78.1%
- classified as malfunction
- 80.1% across the product code
- 2%
- classified as death, as reported
- 9 reports · not verified by FDA
456 medical device reports received by FDA name the brand "Cool-tip" (electrosurgical cutting & coagulation & accessories); the manufacturer given most often on reports is Covidien Mfg Dc Boulder; received from February 2017 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
28 reports arrived in the 12 months to August 2026, up 12% from 25 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 (78.1%), injury (20%) and death (2%); 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 temperature problem (42.3%), no flow (14.3%) and device alarm system (5.7%). The patient problems coded most often are burn(s), no patient involvement and appropriate clinical signs, symptoms and conditions term/code not available. 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 |
|---|---|---|---|
| Temperature problem | 193 | 42.3% | 0.5% |
| No flow | 65 | 14.3% | 0.2% |
| Device alarm system | 26 | 5.7% | 0.9% |
| Device displays incorrect message | 19 | 4.2% | 2.9% |
| Peeled/delaminated | 16 | 3.5% | 3% |
| Breakthe device broke | 14 | 3.1% | 14% |
| Detachment of device or device componentpart of the device came off | 14 | 3.1% | 3.8% |
| Failure to fire | 14 | 3.1% | 0.2% |
| Intermittent energy output | 14 | 3.1% | 0.7% |
| Flare or flash | 10 | 2.2% | 0.2% |
| Difficult or delayed activation | 7 | 1.5% | 0.3% |
| Overheating of device | 7 | 1.5% | 1.3% |
| Connection problema connection problem | 6 | 1.3% | 0.7% |
| Ambient temperature problem | 5 | 1.1% | 0% |
| Energy output problem | 5 | 1.1% | 3.6% |
| Image display error/artifact | 4 | 0.9% | 0.2% |
| Inaccurate delivery | 4 | 0.9% | 0.2% |
| Difficult to removethe device was hard to remove | 3 | 0.7% | 0.7% |
| Component missing | 2 | 0.4% | 0.5% |
| Device damaged prior to receipt by user | 2 | 0.4% | 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 | 38 | 8.3% |
| No patient involvement | 34 | 7.5% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 20 | 4.4% |
| Partial thickness (second degree) burn | 20 | 4.4% |
| Superficial (first degree) burn | 15 | 3.3% |
| Laceration(s) | 7 | 1.5% |
| Full thickness (third degree) burn | 6 | 1.3% |
| Deaththe patient died; cause not stated by this term | 5 | 1.1% |
| Skin discoloration | 5 | 1.1% |
| Injurya physical injury | 4 | 0.9% |
| Hemorrhage/blood loss/bleeding | 3 | 0.7% |
| Pleural effusionfluid around the lung | 3 | 0.7% |
| Arrhythmia | 2 | 0.4% |
| Chest painchest pain | 2 | 0.4% |
| Fever | 2 | 0.4% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Cool-tip | Product code GEI | All MAUDE reports |
|---|---|---|---|
| Reports | 456 | 118,290 | 26,136,888 |
| Share of that pool | — | 0.4% | 0% |
| Classified as death, per 1,000 reports | 20 | 4 | 9 |
| Classified as injury | 20% | 16.7% | 36.2% |
| Classified as malfunction | 78.1% | 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 Cool-tip reports
How many FDA reports name Cool-tip?
456 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 28 in the latest 12 months.
What kinds of events are reported?
malfunction (78.1%), injury (20%) and death (2%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
temperature problem (42.3%), no flow (14.3%), device alarm system (5.7%), device displays incorrect message (4.2%) and peeled/delaminated (3.5%). 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 Cool-tip 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.