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FDA product code GDW · class 2 · General, Plastic Surgery
Staple, implantable: medical device reports filed with FDA
170,752 reports carry this product code, 1993–2026; 30 brands with a page.
- 170,752
- reports with this product code
- 0.7% of all MAUDE reports
- 11,701
- reports, 12 months to August 2026
- 12,446 in the 12 months before
- 80.3%
- classified as malfunction
- 62.3% across all reports
- 0.6%
- classified as death, as reported
- 0.9% across all reports
Product code GDW is FDA's classification for "Staple, implantable" (general, Plastic Surgery panel), a class 2 device. 170,752 medical device reports carry this product code, 0.7% of the MAUDE database, from September 1993 to August 2026.
11,701 reports arrived in the 12 months to August 2026, close to the 12,446 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 (80.3%), injury (18.7%) and death (0.6%). 30 brand names with a page on this site carry this code; the brands table is 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."
Brands with this product code
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."
Manufacturers named
| Manufacturer (as written on reports) | Reports | Share |
|---|---|---|
| Ethicon Endo-Surgery | 65,613 | 38.4% |
| Covidien North Haven | 39,073 | 22.9% |
| US Surgical Puerto Rico | 33,239 | 19.5% |
| Covidien | 4,227 | 2.5% |
| Covidien Surgical | 4,044 | 2.4% |
| Intuitive Surgical | 2,481 | 1.5% |
| Ethicon Endo-Surgery Cincinnati | 1,990 | 1.2% |
| Covidien Formerly US Surgical A Divison | 1,907 | 1.1% |
| Ethicon Endo Surgery Cincinnati | 1,500 | 0.9% |
| Covidien Formerly Ussc Puerto Rico | 1,462 | 0.9% |
| United States Surgical | 1,216 | 0.7% |
| Celestica De Monterrey De C V | 992 | 0.6% |
| North Haven - Uss | 986 | 0.6% |
| Power Medical Interventions | 852 | 0.5% |
| Davol Sub C R Bard -1213643 | 828 | 0.5% |
Reports by month, five years
FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.
Event type and report source
Event type
Who filed
Grey bar: all 26,136,888 MAUDE reports.
Device problems coded
| Device problem (FDA code) | Reports | Share |
|---|---|---|
| Failure to fire | 51,171 | 30% |
| Failure to form staple | 34,995 | 20.5% |
| Difficult to open or close | 16,576 | 9.7% |
| Misfire | 15,493 | 9.1% |
| Breakthe device broke | 8,377 | 4.9% |
| Entrapment of device | 5,516 | 3.2% |
| Insufficient device problem information | 4,970 | 2.9% |
| Failure to cut | 4,177 | 2.4% |
| Human-device interface problem | 4,069 | 2.4% |
| Detachment of device or device componentpart of the device came off | 4,054 | 2.4% |
| Mechanical jam | 4,004 | 2.3% |
| Device operates differently than expectedthe device behaved unexpectedly | 3,958 | 2.3% |
| Noise, audible | 3,927 | 2.3% |
| Replace | 3,829 | 2.2% |
| Difficult to removethe device was hard to remove | 2,855 | 1.7% |
| Firing problem | 2,735 | 1.6% |
| Mechanics altered | 2,415 | 1.4% |
| Sticking | 2,098 | 1.2% |
| Detachment of device component | 2,096 | 1.2% |
| Retraction problem | 2,083 | 1.2% |
Questions about staple, implantable reports
What is product code GDW?
FDA's classification code for "Staple, implantable", class 2, reviewed by the general, Plastic Surgery panel. Every device report carries the product code of the device involved.
How many reports carry this code?
170,752 reports through August 2026, 11,701 of them in the latest 12 months.
Which brands appear most often?
Endo GIA (30,587), Endo GIA Ultra (17,277), Signia (9,378), Tri-Staple 2.0 (5,252) and Gia (3,768). Widely used products collect more reports because more people use them.
Can the brands table be used to rank the devices?
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." Brands differ in how many are in use, how long they have been sold and how reports are collected.
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. 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.