Reported Reactions

Devices › Electrosurgical, cutting & coagulation & accessories

Device brand name · Probe

Serfas Energy Super 90-S: medical device reports filed with FDA

178 reports name it, 2008–2015. Manufacturer given most often on reports: Stryker Endoscopy Puerto Rico. Product code GEI.

178
device reports naming the brand
0% of all MAUDE reports · about 10 a year
0
reports, 12 months to August 2026
0 in the 12 months before
90.4%
classified as malfunction
80.1% across the product code
0%
classified as death, as reported
0 reports · not verified by FDA

178 medical device reports received by FDA name the brand "Serfas Energy Super 90-S" (probe); the manufacturer given most often on reports is Stryker Endoscopy Puerto Rico; received from July 2008 to December 2015. 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 (90.4%) and injury (9.6%); 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 break (48.3%), detachment of device component (30.9%) and component falling (9%). The patient problems coded most often are device embedded in tissue or plaque, burn, thermal 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 Serfas Energy Super 90-S was received in the five years to August 2026; the latest was received in December 2015.

By year received

026522008: 720082009: 2520092010: 2820102011: 5220112012: 1220122013: 2220132014: 2020142015: 122015

Event type and report source

Event type, as classified on the report

Death0%0
Injury9.6%17
Malfunction90.4%161
Other0%0
Not given0%0

Who filed the report

Manufacturer report98.3%175
Voluntary report1.7%3
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
Breakthe device broke8648.3%14%
Detachment of device component5530.9%3.5%
Component falling169%1.3%
Self-activation or keying105.6%2.3%
Fracturea broken bone95.1%0.7%
Suction problem63.4%0.1%
Device operates differently than expectedthe device behaved unexpectedly52.8%3.9%
Device or device fragments location unknown42.2%0.3%
Insufficient device problem information42.2%2.8%
Peeled/delaminated42.2%3%
Detachment of device or device componentpart of the device came off31.7%3.8%
Device inoperablethe device could not be used31.7%1.5%
Device slipped31.7%0.2%
Complete blockage21.1%0.1%
Defective devicethe device was defective21.1%0.6%
Device remains activated21.1%1.3%
Loss of powerthe device lost power21.1%0.4%
Melted21.1%1.5%
Sticking21.1%1.5%
Arcing10.6%0.9%

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
Device embedded in tissue or plaque126.7%
Burn, thermal31.7%
Painpain, site not specified21.1%
Burn(s)a burn10.6%
Electric shockan electric shock10.6%
Foreign body in patientpart of a device left in the patient10.6%
Foreign body, removal of10.6%
Full thickness (third degree) burn10.6%
Impaired healingslow healing10.6%
Necrosisdeath of tissue10.6%
No patient involvement10.6%
Tissue damage10.6%

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

In context

MeasureSerfas Energy Super 90-SProduct code GEIAll MAUDE reports
Reports178118,29026,136,888
Share of that pool—0.2%0%
Classified as death, per 1,000 reports049
Classified as injury9.6%16.7%36.2%
Classified as malfunction90.4%80.1%62.3%
Filed by the manufacturer98.3%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 Serfas Energy Super 90-S reports

How many FDA reports name Serfas Energy Super 90-S?

178 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 (90.4%) and injury (9.6%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

break (48.3%), detachment of device component (30.9%), component falling (9%), self-activation or keying (5.6%) and fracture (5.1%). These are FDA's device problem codes as entered on the report.

Who files these reports?

manufacturer reports (98.3%) and voluntary reports (1.7%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.

Do these reports show that Serfas Energy Super 90-S 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.