Devices › Electrosurgical, cutting & coagulation & accessories
Device brand name · Electrosurgical cutting & coagulation & accessories
Gyrus Pk-Sp Generator: medical device reports filed with FDA
305 reports name it, 2017–2026. Manufacturer given most often on reports: Gyrus Acmi. Product code GEI.
- 305
- device reports naming the brand
- 0% of all MAUDE reports · about 32 a year
- 24
- reports, 12 months to August 2026
- 43 in the 12 months before
- 97%
- 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 305 reports that name the brand "Gyrus Pk-Sp Generator" (electrosurgical cutting & coagulation & accessories), received between February 2017 and August 2026; the manufacturer given most often on reports is Gyrus Acmi. Spellings of one product vary from report to report.
24 reports arrived in the 12 months to August 2026, down 44% from 43 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 (97%) and injury (3%); 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 output problem (33.1%), electrical /electronic property problem (13.4%) and no device output (8.5%). The patient problems coded most often are no patient involvement and blood loss. 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 |
|---|---|---|---|
| Output problem | 101 | 33.1% | 1.5% |
| Electrical /electronic property probleman electrical or electronic problem | 41 | 13.4% | 2.7% |
| No device output | 26 | 8.5% | 0.2% |
| Energy output problem | 24 | 7.9% | 3.6% |
| Breakthe device broke | 15 | 4.9% | 14% |
| Communication or transmission problemthe device could not communicate or transmit | 14 | 4.6% | 1.2% |
| Output below specifications | 14 | 4.6% | 0.1% |
| Circuit failure | 11 | 3.6% | 0.2% |
| Defective component | 8 | 2.6% | 0.3% |
| Failure to deliver energy | 8 | 2.6% | 1.3% |
| Intermittent energy output | 8 | 2.6% | 0.7% |
| Loss of powerthe device lost power | 7 | 2.3% | 0.4% |
| Failure to cut | 6 | 2% | 1.4% |
| Activation problem | 5 | 1.6% | 0.6% |
| Connection problema connection problem | 5 | 1.6% | 0.7% |
| Inability to irrigate | 5 | 1.6% | 0% |
| Power problem | 5 | 1.6% | 0.3% |
| Intermittent loss of power | 4 | 1.3% | 0.1% |
| Defective devicethe device was defective | 3 | 1% | 0.6% |
| Failure to power up | 3 | 1% | 0.4% |
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 |
|---|---|---|
| No patient involvement | 14 | 4.6% |
| Blood loss | 1 | 0.3% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Gyrus Pk-Sp Generator | Product code GEI | All MAUDE reports |
|---|---|---|---|
| Reports | 305 | 118,290 | 26,136,888 |
| Share of that pool | — | 0.3% | 0% |
| Classified as death, per 1,000 reports | 0 | 4 | 9 |
| Classified as injury | 3% | 16.7% | 36.2% |
| Classified as malfunction | 97% | 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 Gyrus Pk-Sp Generator reports
How many FDA reports name Gyrus Pk-Sp Generator?
305 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 24 in the latest 12 months.
What kinds of events are reported?
malfunction (97%) and injury (3%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
output problem (33.1%), electrical /electronic property problem (13.4%), no device output (8.5%), energy output problem (7.9%) and break (4.9%). 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 Gyrus Pk-Sp Generator 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.