Device brand name · Staple implantable
Signia: medical device reports filed with FDA
9,434 reports name it, 2017–2026. Manufacturer given most often on reports: Covidien North Haven. Product code GDW.
- 9,434
- device reports naming the brand
- 0% of all MAUDE reports · about 1,020 a year
- 1,130
- reports, 12 months to August 2026
- 1,180 in the 12 months before
- 93.5%
- classified as malfunction
- 80.3% across the product code
- 0.1%
- classified as death, as reported
- 7 reports · not verified by FDA
9,434 medical device reports received by FDA name the brand "Signia" (staple implantable); the manufacturer given most often on reports is Covidien North Haven; received from April 2017 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
1,130 reports arrived in the 12 months to August 2026, close to the 1,180 of 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 (93.5%), injury (6.4%) and death (0.1%); 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 misfire (20.9%), complete loss of power (17.1%) and failure to charge (14.2%). The patient problems coded most often are no patient involvement, tissue breakdown and hemorrhage/blood loss/bleeding. 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 |
|---|---|---|---|
| Misfire | 1,970 | 20.9% | 9.1% |
| Complete loss of power | 1,616 | 17.1% | 0.9% |
| Failure to charge | 1,341 | 14.2% | 0.8% |
| Failure to fire | 1,239 | 13.1% | 30% |
| Difficult to open or close | 1,129 | 12% | 9.7% |
| Entrapment of device | 1,088 | 11.5% | 3.2% |
| Device displays incorrect message | 1,042 | 11% | 1.2% |
| Power problem | 524 | 5.6% | 0.3% |
| Human-device interface problem | 444 | 4.7% | 2.4% |
| Insufficient device problem information | 431 | 4.6% | 2.9% |
| Breakthe device broke | 361 | 3.8% | 4.9% |
| Corrodedthe device corroded | 329 | 3.5% | 0.2% |
| Retraction problem | 318 | 3.4% | 1.2% |
| Failure to power up | 274 | 2.9% | 0.2% |
| Noise, audible | 265 | 2.8% | 2.3% |
| Computer software problema software problem | 243 | 2.6% | 0.1% |
| Failure to form staple | 203 | 2.2% | 20.5% |
| Unintended movement | 195 | 2.1% | 0.3% |
| Device difficult to setup or prepare | 169 | 1.8% | 0.4% |
| Mechanics altered | 167 | 1.8% | 1.4% |
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 | 622 | 6.6% |
| Tissue breakdown | 507 | 5.4% |
| Hemorrhage/blood loss/bleeding | 168 | 1.8% |
| Tissue damage | 122 | 1.3% |
| Laceration(s) | 96 | 1% |
| Failure to anastomose | 84 | 0.9% |
| Blood loss | 26 | 0.3% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 15 | 0.2% |
| Abdominal painstomach or belly pain | 11 | 0.1% |
| Ear infectionan ear infection | 9 | 0.1% |
| Injurya physical injury | 9 | 0.1% |
| Fever | 8 | 0.1% |
| Unintended radiation exposure | 8 | 0.1% |
| Cardiac arrestthe heart stopped | 6 | 0.1% |
| Perforation | 6 | 0.1% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Signia | Product code GDW | All MAUDE reports |
|---|---|---|---|
| Reports | 9,434 | 170,752 | 26,136,888 |
| Share of that pool | — | 5.5% | 0% |
| Classified as death, per 1,000 reports | 1 | 6 | 9 |
| Classified as injury | 6.4% | 18.7% | 36.2% |
| Classified as malfunction | 93.5% | 80.3% | 62.3% |
| Filed by the manufacturer | 99.7% | 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% |
| 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% |
| 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 Signia reports
How many FDA reports name Signia?
9,434 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 1,130 in the latest 12 months.
What kinds of events are reported?
malfunction (93.5%), injury (6.4%) and death (0.1%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
misfire (20.9%), complete loss of power (17.1%), failure to charge (14.2%), failure to fire (13.1%) and difficult to open or close (12%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.7%) and distributor reports (0%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Signia 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.