Reported Reactions

Devices › Electrosurgical, cutting & coagulation & accessories

Device brand name · Rf ablation grounding pad

Hi Pwr Disposbl Grnding Pad: medical device reports filed with FDA

235 reports name it, 2006–2015. Manufacturer given most often on reports: Covidien Valleylab. Product code GEI.

235
device reports naming the brand
0% of all MAUDE reports · about 12 a year
0
reports, 12 months to August 2026
0 in the 12 months before
88.5%
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 235 reports that name the brand "Hi Pwr Disposbl Grnding Pad" (rf ablation grounding pad), received between February 2006 and December 2015; the manufacturer given most often on reports is Covidien Valleylab. Spellings of one product vary from report to report.

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 (88.5%) and injury (10.6%); 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 material discolored (24.7%), degraded (16.2%) and insufficient device problem information (14.5%). The patient problems coded most often are burn, thermal, partial thickness (second degree) burn and pain. 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 Hi Pwr Disposbl Grnding Pad was received in the five years to August 2026; the latest was received in December 2015.

By year received

044872006: 620062007: 3320072008: 2820082009: 1920092010: 420102011: 8720112012: 4720122014: 520142015: 62015

Event type and report source

Event type, as classified on the report

Death0%0
Injury10.6%25
Malfunction88.5%208
Other0%0
Not given0.9%2

Who filed the report

Manufacturer report100%235
Voluntary report0%0
User facility report0%0
Distributor report0%0
Not given0%0

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
Material discolored5824.7%0.2%
Degraded3816.2%0.3%
Insufficient device problem information3414.5%2.8%
Device contamination with chemical or other material239.8%0.2%
Replace135.5%2.8%
Corrodedthe device corroded114.7%0.1%
Overheating of device114.7%1.3%
Circuit failure104.3%0.2%
Device operates differently than expectedthe device behaved unexpectedly93.8%3.9%
Out-of-box failure83.4%0.1%
Electrical /electronic property probleman electrical or electronic problem73%2.7%
High impedance73%0.1%
Heat62.6%0.1%
Breakthe device broke41.7%14%
Crackthe device cracked31.3%0.5%
Device contaminated during manufacture or shipping31.3%0.1%
Device issuea problem with the device31.3%1%
Nonstandard device31.3%0.1%
Product quality problem31.3%0.1%
Device displays incorrect message20.9%2.9%

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, thermal5423%
Partial thickness (second degree) burn239.8%
Painpain, site not specified177.2%
Therapy/non-surgical treatment, additional177.2%
Erythemaskin redness146%
No patient involvement146%
Treatment with medication(s)146%
Blister(s)114.7%
Superficial (first degree) burn114.7%
Swellingswelling93.8%
Hospitalization required73%
Burn(s)a burn41.7%
Full thickness (third degree) burn41.7%
Therapy/non-surgical treatment/delayed/prolonged41.7%
Rashskin rash31.3%

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

In context

MeasureHi Pwr Disposbl Grnding PadProduct code GEIAll MAUDE reports
Reports235118,29026,136,888
Share of that pool—0.2%0%
Classified as death, per 1,000 reports049
Classified as injury10.6%16.7%36.2%
Classified as malfunction88.5%80.1%62.3%
Filed by the manufacturer100%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 Hi Pwr Disposbl Grnding Pad reports

How many FDA reports name Hi Pwr Disposbl Grnding Pad?

235 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 (88.5%) and injury (10.6%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

material discolored (24.7%), degraded (16.2%), insufficient device problem information (14.5%), device contamination with chemical or other material (9.8%) and replace (5.5%). 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 Hi Pwr Disposbl Grnding Pad 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.