Reported Reactions

Devices › Electrosurgical, cutting & coagulation & accessories

Device brand name · Electrosurgical cutting & coagulation & accessories

ForceTriad: medical device reports filed with FDA

420 reports name it, 2010–2026. Manufacturer given most often on reports: Covidien Mfg Dc Boulder. Product code GEI.

420
device reports naming the brand
0% of all MAUDE reports · about 26 a year
13
reports, 12 months to August 2026
20 in the 12 months before
89.8%
classified as malfunction
80.1% across the product code
0.2%
classified as death, as reported
1 reports · not verified by FDA

420 medical device reports received by FDA name the brand "ForceTriad" (electrosurgical cutting & coagulation & accessories); the manufacturer given most often on reports is Covidien Mfg Dc Boulder; received from August 2010 to July 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.

13 reports arrived in the 12 months to August 2026, down 35% from 20 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 (89.8%), injury (6.9%) and death (0.2%); 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 self-activation or keying (26.9%), connection problem (16.2%) and energy output problem (11.7%). The patient problems coded most often are burn(s), no patient involvement and superficial (first degree) burn. 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

059Sep 2021: 5Oct 2021: 9Nov 2021: 6Dec 2021: 72022Jan 2022: 7Feb 2022: 4Mar 2022: 8Apr 2022: 5May 2022: 2Jun 2022: 2Jul 2022: 3Aug 2022: 1Sep 2022: 5Oct 2022: 6Nov 2022: 4Dec 2022: 42023Jan 2023: 1Feb 2023: 7Mar 2023: 3Apr 2023: 6May 2023: 2Jun 2023: 4Jul 2023: 5Aug 2023: 4Sep 2023: 6Oct 2023: 6Nov 2023: 1Dec 2023: 42024Jan 2024: 6Feb 2024: 1Mar 2024: 1Apr 2024: 1May 2024: 5Jun 2024: 4Jul 2024: 7Aug 2024: 2Sep 2024: 2Oct 2024: 1Nov 2024: 0Dec 2024: 42025Jan 2025: 0Feb 2025: 1Mar 2025: 2Apr 2025: 4May 2025: 3Jun 2025: 2Jul 2025: 0Aug 2025: 1Sep 2025: 1Oct 2025: 1Nov 2025: 2Dec 2025: 02026Jan 2026: 1Feb 2026: 2Mar 2026: 1Apr 2026: 1May 2026: 0Jun 2026: 2Jul 2026: 2Aug 2026: 0

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

030592010: 720102011: 102013: 320132015: 32017: 2420172018: 572019: 5720192020: 402021: 5920212022: 512023: 4920232024: 342025: 1720252026: 9

Event type and report source

Event type, as classified on the report

Death0.2%1
Injury6.9%29
Malfunction89.8%377
Other0%0
Not given3.1%13

Who filed the report

Manufacturer report92.4%388
Voluntary report0.5%2
User facility report0%0
Distributor report0%0
Not given7.1%30

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)ReportsShareShare across product code
Self-activation or keying11326.9%2.3%
Connection problema connection problem6816.2%0.7%
Energy output problem4911.7%3.6%
Inaccurate delivery337.9%0.2%
Device displays incorrect message256%2.9%
Device remains activated245.7%1.3%
Failure to calibrate153.6%0.1%
Breakthe device broke143.3%14%
Fire112.6%1.8%
Electrical shorting102.4%0.5%
Device alarm system71.7%0.9%
Failure to align71.7%0.3%
Failure to deliver energy71.7%1.3%
Flare or flash71.7%0.2%
Arcing61.4%0.9%
Image display error/artifact61.4%0.2%
Intermittent energy output61.4%0.7%
Material integrity problema problem with the device material51.2%0.6%
Insufficient device problem information41%2.8%
Defective alarm30.7%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)ReportsShare
Burn(s)a burn7718.3%
No patient involvement6214.8%
Superficial (first degree) burn245.7%
Hemorrhage/blood loss/bleeding184.3%
Partial thickness (second degree) burn112.6%
Electric shockan electric shock71.7%
Burn, thermal61.4%
Full thickness (third degree) burn51.2%
Appropriate clinical signs, symptoms and conditions term/code not available30.7%
Bowel burn30.7%
Blood loss20.5%
Abdominal painstomach or belly pain10.2%
Alteration in body temperature10.2%
Anxietyanxiety10.2%
Ascitesfluid in the abdomen10.2%

Patient problem codes are present mainly in reports filed since 2019 and are often blank.

In context

MeasureForceTriadProduct code GEIAll MAUDE reports
Reports420118,29026,136,888
Share of that pool—0.4%0%
Classified as death, per 1,000 reports249
Classified as injury6.9%16.7%36.2%
Classified as malfunction89.8%80.1%62.3%
Filed by the manufacturer92.4%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

BrandReportsLatest 12 monthsClassified as death
LigaSure8,2648790.2%
VasoView Hemopro 26,6336860%
THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type S4,5904030%
HF unit "ESG-400"2,6986640.1%
Valleylab2,0103530.3%
Vaso View Hemopro1,83800.1%
LigaSure Impact1,831720.3%
THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip1,505380.3%
Thunderbeat 5mm 35cm Front-Actuated Grip1,24700.2%
Valleylab Ft101,20320.3%
Vasoview Hemopro1,18700%
Ligasure Advance Pistol Grip97000%
Ligasure Atlas Handswitching 37cm92400.2%
Edge8591710.1%
Force Fx780220.4%

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 ForceTriad reports

How many FDA reports name ForceTriad?

420 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 13 in the latest 12 months.

What kinds of events are reported?

malfunction (89.8%), injury (6.9%) and death (0.2%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

self-activation or keying (26.9%), connection problem (16.2%), energy output problem (11.7%), inaccurate delivery (7.9%) and device displays incorrect message (6%). These are FDA's device problem codes as entered on the report.

Who files these reports?

manufacturer reports (92.4%) and voluntary reports (0.5%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.

Do these reports show that ForceTriad 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.