Device brand name · Staple implantable
Proximate: medical device reports filed with FDA
386 reports name it, 1998–2026. Manufacturer given most often on reports: Ethicon Endo-Surgery. Product code GDW.
- 386
- device reports naming the brand
- 0% of all MAUDE reports · about 14 a year
- 102
- reports, 12 months to August 2026
- 9 in the 12 months before
- 86%
- classified as malfunction
- 80.3% across the product code
- 1%
- classified as death, as reported
- 4 reports · not verified by FDA
386 medical device reports received by FDA name the brand "Proximate" (staple implantable); the manufacturer given most often on reports is Ethicon Endo-Surgery; received from April 1998 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
102 reports arrived in the 12 months to August 2026, up 1033% from 9 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 (86%), injury (11.9%) and death (1%); 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 failure to form staple (19.7%), failure to fire (16.1%) and misfire (13.5%). The patient problems coded most often are failure to anastomose, hemorrhage/blood loss/bleeding and surgical procedure, 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
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 |
|---|---|---|---|
| Failure to form staple | 76 | 19.7% | 20.5% |
| Failure to fire | 62 | 16.1% | 30% |
| Misfire | 52 | 13.5% | 9.1% |
| Firing problem | 17 | 4.4% | 1.6% |
| Mechanics altered | 16 | 4.1% | 1.4% |
| Mechanical jam | 13 | 3.4% | 2.3% |
| Insufficient device problem information | 12 | 3.1% | 2.9% |
| Device operates differently than expectedthe device behaved unexpectedly | 10 | 2.6% | 2.3% |
| Positioning failure | 10 | 2.6% | 1.1% |
| Failure to cut | 8 | 2.1% | 2.4% |
| Breakthe device broke | 5 | 1.3% | 4.9% |
| Delivered as unsterile product | 5 | 1.3% | 0.3% |
| Difficult to open or close | 5 | 1.3% | 9.7% |
| Mechanical problema mechanical problem | 5 | 1.3% | 1.1% |
| Activation, positioning or separation problem | 4 | 1% | 0.2% |
| Defective devicethe device was defective | 4 | 1% | 0.2% |
| Detachment of device component | 4 | 1% | 1.2% |
| Device inoperablethe device could not be used | 4 | 1% | 0.5% |
| Material integrity problema problem with the device material | 4 | 1% | 0.7% |
| Detachment of device or device componentpart of the device came off | 3 | 0.8% | 2.4% |
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 |
|---|---|---|
| Failure to anastomose | 35 | 9.1% |
| Hemorrhage/blood loss/bleeding | 16 | 4.1% |
| Surgical procedure, additional | 6 | 1.6% |
| Hospitalization required | 5 | 1.3% |
| Deaththe patient died; cause not stated by this term | 4 | 1% |
| Tissue damage | 4 | 1% |
| Wound dehiscencea wound reopened | 3 | 0.8% |
| Abscessa collection of pus | 2 | 0.5% |
| Bleeding | 2 | 0.5% |
| Injurya physical injury | 2 | 0.5% |
| Laceration(s) | 2 | 0.5% |
| Perforation | 2 | 0.5% |
| Peritonitis | 2 | 0.5% |
| Sepsisa severe body-wide response to infection | 2 | 0.5% |
| Abdominal distention | 1 | 0.3% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Proximate | Product code GDW | All MAUDE reports |
|---|---|---|---|
| Reports | 386 | 170,752 | 26,136,888 |
| Share of that pool | — | 0.2% | 0% |
| Classified as death, per 1,000 reports | 10 | 6 | 9 |
| Classified as injury | 11.9% | 18.7% | 36.2% |
| Classified as malfunction | 86% | 80.3% | 62.3% |
| Filed by the manufacturer | 32.4% | 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 Proximate reports
How many FDA reports name Proximate?
386 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 102 in the latest 12 months.
What kinds of events are reported?
malfunction (86%), injury (11.9%) and death (1%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
failure to form staple (19.7%), failure to fire (16.1%), misfire (13.5%), firing problem (4.4%) and mechanics altered (4.1%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (32.4%) and voluntary reports (1.6%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Proximate 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.