Devices › Electrosurgical, cutting & coagulation & accessories
Device brand name · Gei
Hs Hand Controlled Curved Shea: medical device reports filed with FDA
589 reports name it, 2004–2009. Manufacturer given most often on reports: Ethicon Endo-Surgery Cincinnati. Product code GEI.
- 589
- device reports naming the brand
- 0% of all MAUDE reports · about 27 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 98.3%
- classified as malfunction
- 80.1% across the product code
- 0.2%
- classified as death, as reported
- 1 reports · not verified by FDA
FDA's MAUDE database holds 589 reports that name the brand "Hs Hand Controlled Curved Shea" (gei), received between October 2004 and October 2009; the manufacturer given most often on reports is Ethicon Endo-Surgery Cincinnati. 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 (98.3%), injury (1.2%) 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 replace (52.8%), device displays incorrect message (26.1%) and device issue (17.7%). The patient problems coded most often are foreign body, removal of, nonresorbable materials, unretrieved in body and therapy/non-surgical treatment, additional. 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 Hs Hand Controlled Curved Shea was received in the five years to August 2026; the latest was received in October 2009.
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 |
|---|---|---|---|
| Replace | 311 | 52.8% | 2.8% |
| Device displays incorrect message | 154 | 26.1% | 2.9% |
| Device issuea problem with the device | 104 | 17.7% | 1% |
| Device inoperablethe device could not be used | 94 | 16% | 1.5% |
| Breakthe device broke | 52 | 8.8% | 14% |
| Tip breakage | 43 | 7.3% | 1.1% |
| Component(s), broken | 40 | 6.8% | 0.5% |
| Detachment of device component | 32 | 5.4% | 3.5% |
| System fails to activate | 30 | 5.1% | 0.1% |
| Device operates differently than expectedthe device behaved unexpectedly | 27 | 4.6% | 3.9% |
| Component falling | 25 | 4.2% | 1.3% |
| Device, removal of (non-implant) | 16 | 2.7% | 0.4% |
| Noise | 15 | 2.5% | 0.2% |
| Repair | 13 | 2.2% | 0.1% |
| Failure to cut | 10 | 1.7% | 1.4% |
| Failure, intermittent | 10 | 1.7% | 0.1% |
| Defective component | 8 | 1.4% | 0.3% |
| Mechanical problema mechanical problem | 7 | 1.2% | 1.2% |
| Alarm, audible | 6 | 1% | 0.1% |
| Difficult or delayed activation | 6 | 1% | 0.3% |
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 |
|---|---|---|
| Foreign body, removal of | 27 | 4.6% |
| Nonresorbable materials, unretrieved in body | 6 | 1% |
| Therapy/non-surgical treatment, additional | 6 | 1% |
| No patient involvement | 4 | 0.7% |
| Surgery, prolonged | 3 | 0.5% |
| Surgical procedure, additional | 3 | 0.5% |
| Laparotomy | 2 | 0.3% |
| Bleeding | 1 | 0.2% |
| Failure to anastomose | 1 | 0.2% |
| Hemorrhage/blood loss/bleeding | 1 | 0.2% |
| Therapeutic response, decreased | 1 | 0.2% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Hs Hand Controlled Curved Shea | Product code GEI | All MAUDE reports |
|---|---|---|---|
| Reports | 589 | 118,290 | 26,136,888 |
| Share of that pool | — | 0.5% | 0% |
| Classified as death, per 1,000 reports | 2 | 4 | 9 |
| Classified as injury | 1.2% | 16.7% | 36.2% |
| Classified as malfunction | 98.3% | 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 Hs Hand Controlled Curved Shea reports
How many FDA reports name Hs Hand Controlled Curved Shea?
589 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 (98.3%), injury (1.2%) and death (0.2%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
replace (52.8%), device displays incorrect message (26.1%), device issue (17.7%), device inoperable (16%) and break (8.8%). 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 Hs Hand Controlled Curved Shea 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.