Device brand name · Staple implantable
Echelon Flex 45 Standard: medical device reports filed with FDA
745 reports name it, 2017–2026. Manufacturer given most often on reports: Ethicon Endo-Surgery. Product code GDW.
- 745
- device reports naming the brand
- 0% of all MAUDE reports · about 81 a year
- 40
- reports, 12 months to August 2026
- 90 in the 12 months before
- 88.2%
- classified as malfunction
- 80.3% across the product code
- 1.2%
- classified as death, as reported
- 9 reports · not verified by FDA
FDA's MAUDE database holds 745 reports that name the brand "Echelon Flex 45 Standard" (staple implantable), received between May 2017 and March 2026; the manufacturer given most often on reports is Ethicon Endo-Surgery. Spellings of one product vary from report to report.
40 reports arrived in the 12 months to August 2026, down 56% from 90 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 (88.2%), injury (10.6%) and death (1.2%); across all staple, implantable reports (product code GDW) death is recorded in 0.6% and malfunction in 80.3%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are difficult to open or close (40.4%), failure to form staple (25.1%) and failure to fire (20.7%). The patient problems coded most often are hemorrhage/blood loss/bleeding, blood loss and failure to anastomose. 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 170,752 reports carrying product code GDW. 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 |
|---|---|---|---|
| Difficult to open or close | 301 | 40.4% | 9.7% |
| Failure to form staple | 187 | 25.1% | 20.5% |
| Failure to fire | 154 | 20.7% | 30% |
| Mechanical jam | 59 | 7.9% | 2.3% |
| Mechanical problema mechanical problem | 32 | 4.3% | 1.1% |
| Failure to cut | 24 | 3.2% | 2.4% |
| Firing problem | 24 | 3.2% | 1.6% |
| Material integrity problema problem with the device material | 23 | 3.1% | 0.7% |
| Retraction problem | 12 | 1.6% | 1.2% |
| Physical resistance/sticking | 11 | 1.5% | 0.3% |
| Insufficient device problem information | 10 | 1.3% | 2.9% |
| Device operates differently than expectedthe device behaved unexpectedly | 9 | 1.2% | 2.3% |
| Device markings/labelling problema problem with the device markings or label | 8 | 1.1% | 0.2% |
| Delivered as unsterile product | 6 | 0.8% | 0.3% |
| Ejection problem | 6 | 0.8% | 0.8% |
| Breakthe device broke | 5 | 0.7% | 4.9% |
| Activation, positioning or separation problem | 4 | 0.5% | 0.2% |
| Detachment of device or device componentpart of the device came off | 4 | 0.5% | 2.4% |
| Dull, blunt | 4 | 0.5% | 0% |
| Positioning failure | 4 | 0.5% | 1.1% |
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 |
|---|---|---|
| Hemorrhage/blood loss/bleeding | 31 | 4.2% |
| Blood loss | 29 | 3.9% |
| Failure to anastomose | 10 | 1.3% |
| Not applicable | 9 | 1.2% |
| Deaththe patient died; cause not stated by this term | 6 | 0.8% |
| Fistula | 3 | 0.4% |
| Tachycardiafast heart rate | 3 | 0.4% |
| Abdominal painstomach or belly pain | 2 | 0.3% |
| Cardiac arrestthe heart stopped | 2 | 0.3% |
| Abdominal distention | 1 | 0.1% |
| Anemialow red blood cells | 1 | 0.1% |
| High blood pressure/ hypertension | 1 | 0.1% |
| Low blood pressure/ hypotension | 1 | 0.1% |
| Necrosisdeath of tissue | 1 | 0.1% |
| Painpain, site not specified | 1 | 0.1% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Echelon Flex 45 Standard | Product code GDW | All MAUDE reports |
|---|---|---|---|
| Reports | 745 | 170,752 | 26,136,888 |
| Share of that pool | — | 0.4% | 0% |
| Classified as death, per 1,000 reports | 12 | 6 | 9 |
| Classified as injury | 10.6% | 18.7% | 36.2% |
| Classified as malfunction | 88.2% | 80.3% | 62.3% |
| Filed by the manufacturer | 99.9% | 97% | 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 GDW
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Endo GIA | 30,619 | 2,086 | 0.3% |
| Endo GIA Ultra | 17,281 | 1,116 | 0.1% |
| Signia | 9,434 | 1,130 | 0.1% |
| Tri-Staple 2.0 | 5,267 | 661 | 0.3% |
| Gia | 4,899 | 404 | 0.9% |
| Eea | 4,922 | 542 | 0.8% |
| Powered 60 Echelon + 340mm Shaft | 3,237 | 224 | 0.4% |
| Ets Flex Articng Lnr Cutr 45mm | 2,512 | 79 | 0.3% |
| Unknown Endo GIA SULU | 2,408 | 205 | 1.9% |
| SureForm | 2,927 | 654 | 1.2% |
| Contour Curved Cutter Stapler | 1,961 | 11 | 0.3% |
| Ils 29mm Curved | 1,945 | 48 | 0.9% |
| Powered 60 Echelon + 440mm Shaft | 1,775 | 49 | 0.4% |
| Echelon Flex Powered Vascular Stapler With Advanced Placement Tip | 1,770 | 180 | 1.6% |
| 75mm Selectable New Tlc | 1,603 | 57 | 1.1% |
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 Echelon Flex 45 Standard reports
How many FDA reports name Echelon Flex 45 Standard?
745 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 40 in the latest 12 months.
What kinds of events are reported?
malfunction (88.2%), injury (10.6%) and death (1.2%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
difficult to open or close (40.4%), failure to form staple (25.1%), failure to fire (20.7%), mechanical jam (7.9%) and mechanical problem (4.3%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.9%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Echelon Flex 45 Standard 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.