Device brand name · Staple implantable
Tri-Staple 2.0: medical device reports filed with FDA
5,267 reports name it, 2017–2026. Manufacturer given most often on reports: Covidien North Haven. Product code GDW.
- 5,267
- device reports naming the brand
- 0% of all MAUDE reports · about 575 a year
- 661
- reports, 12 months to August 2026
- 589 in the 12 months before
- 84%
- classified as malfunction
- 80.3% across the product code
- 0.3%
- classified as death, as reported
- 16 reports · not verified by FDA
5,267 medical device reports received by FDA name the brand "Tri-Staple 2.0" (staple implantable); the manufacturer given most often on reports is Covidien North Haven; received from May 2017 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
661 reports arrived in the 12 months to August 2026, up 12% from 589 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 (84%), injury (15.7%) and death (0.3%); 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 fire (29.6%), misfire (26.7%) and failure to form staple (14.7%). The patient problems coded most often are tissue breakdown, hemorrhage/blood loss/bleeding 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 |
|---|---|---|---|
| Failure to fire | 1,558 | 29.6% | 30% |
| Misfire | 1,407 | 26.7% | 9.1% |
| Failure to form staple | 776 | 14.7% | 20.5% |
| Entrapment of device | 464 | 8.8% | 3.2% |
| Difficult to open or close | 378 | 7.2% | 9.7% |
| Breakthe device broke | 373 | 7.1% | 4.9% |
| Device displays incorrect message | 284 | 5.4% | 1.2% |
| Detachment of device or device componentpart of the device came off | 232 | 4.4% | 2.4% |
| Human-device interface problem | 227 | 4.3% | 2.4% |
| Insufficient device problem information | 168 | 3.2% | 2.9% |
| Expulsion | 105 | 2% | 0.5% |
| Failure to cut | 95 | 1.8% | 2.4% |
| Retraction problem | 95 | 1.8% | 1.2% |
| Component or accessory incompatibility | 93 | 1.8% | 0.7% |
| Separation failure | 89 | 1.7% | 0.1% |
| Mechanics altered | 83 | 1.6% | 1.4% |
| Noise, audible | 64 | 1.2% | 2.3% |
| Premature activation | 48 | 0.9% | 0.1% |
| Firing problem | 43 | 0.8% | 1.6% |
| Unintended movement | 43 | 0.8% | 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 |
|---|---|---|
| Tissue breakdown | 490 | 9.3% |
| Hemorrhage/blood loss/bleeding | 308 | 5.8% |
| Failure to anastomose | 114 | 2.2% |
| Tissue damage | 100 | 1.9% |
| Laceration(s) | 79 | 1.5% |
| Blood loss | 37 | 0.7% |
| Pulmonary emphysema | 32 | 0.6% |
| Unintended radiation exposure | 31 | 0.6% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 26 | 0.5% |
| Fistula | 24 | 0.5% |
| Foreign body in patientpart of a device left in the patient | 17 | 0.3% |
| Pneumothoraxa collapsed lung | 17 | 0.3% |
| Hematomaa collection of blood under the skin or in tissue | 16 | 0.3% |
| No patient involvement | 16 | 0.3% |
| Radiation exposure, unintended | 13 | 0.2% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Tri-Staple 2.0 | Product code GDW | All MAUDE reports |
|---|---|---|---|
| Reports | 5,267 | 170,752 | 26,136,888 |
| Share of that pool | — | 3.1% | 0% |
| Classified as death, per 1,000 reports | 3 | 6 | 9 |
| Classified as injury | 15.7% | 18.7% | 36.2% |
| Classified as malfunction | 84% | 80.3% | 62.3% |
| Filed by the manufacturer | 99% | 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% |
| 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% |
| Unknown Endo GIA Instrument | 1,512 | 33 | 0.5% |
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 Tri-Staple 2.0 reports
How many FDA reports name Tri-Staple 2.0?
5,267 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 661 in the latest 12 months.
What kinds of events are reported?
malfunction (84%), injury (15.7%) and death (0.3%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
failure to fire (29.6%), misfire (26.7%), failure to form staple (14.7%), entrapment of device (8.8%) and difficult to open or close (7.2%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99%) and voluntary reports (0.1%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Tri-Staple 2.0 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.