Device brand name · Stapler surgical
Ethicon: medical device reports filed with FDA
1,100 reports name it, 1992–2026. Manufacturer given most often on reports: Ethicon. Product code GAG.
- 1,100
- device reports naming the brand
- 0% of all MAUDE reports · about 32 a year
- 164
- reports, 12 months to August 2026
- 4 in the 12 months before
- 54.2%
- classified as malfunction
- 72.9% across the product code
- 2.3%
- classified as death, as reported
- 25 reports · not verified by FDA
FDA's MAUDE database holds 1,100 reports that name the brand "Ethicon" (stapler surgical), received between June 1992 and August 2026; the manufacturer given most often on reports is Ethicon. Spellings of one product vary from report to report.
164 reports arrived in the 12 months to August 2026, up 4000% from 4 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 (54.2%), injury (35.8%) and other (5.3%); across all stapler, surgical reports (product code GAG) death is recorded in 1% and malfunction in 72.9%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are break (14.8%), replace (11%) and failure to form staple (10%). The patient problems coded most often are failure to anastomose, surgical procedure, additional and surgical procedure. 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 26,848 reports carrying product code GAG. 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 |
|---|---|---|---|
| Breakthe device broke | 163 | 14.8% | 1.9% |
| Replace | 121 | 11% | 35.2% |
| Failure to form staple | 110 | 10% | 27.4% |
| Misfire | 110 | 10% | 8.9% |
| Failure to fire | 67 | 6.1% | 8.9% |
| Device issuea problem with the device | 47 | 4.3% | 15.9% |
| Detachment of device component | 43 | 3.9% | 1.8% |
| Sticking | 39 | 3.5% | 10.9% |
| Device operates differently than expectedthe device behaved unexpectedly | 36 | 3.3% | 0.3% |
| Tip breakage | 30 | 2.7% | 0.1% |
| Difficult to removethe device was hard to remove | 28 | 2.5% | 5.7% |
| Malfunction | 22 | 2% | 0.9% |
| Device, or device fragments remain in patient | 21 | 1.9% | 0.2% |
| Positioning failure | 20 | 1.8% | 0.6% |
| Component(s), broken | 18 | 1.6% | 1.1% |
| Device inoperablethe device could not be used | 18 | 1.6% | 0.1% |
| Failure to cut | 18 | 1.6% | 3.6% |
| Suture line separation | 18 | 1.6% | 0.6% |
| Difficult to open or close | 17 | 1.5% | 0.8% |
| Explanted | 15 | 1.4% | 0% |
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 | 127 | 11.5% |
| Surgical procedure, additional | 78 | 7.1% |
| Surgical procedure | 54 | 4.9% |
| Therapy/non-surgical treatment, additional | 54 | 4.9% |
| Surgery, prolonged | 53 | 4.8% |
| Bleeding | 49 | 4.5% |
| Foreign body, removal of | 47 | 4.3% |
| Hospitalization required | 42 | 3.8% |
| Nonresorbable materials, unretrieved in body | 27 | 2.5% |
| Hemorrhage/blood loss/bleeding | 23 | 2.1% |
| Other (for use when an appropriate patient code cannot be identified) | 23 | 2.1% |
| Tissue damage | 23 | 2.1% |
| Painpain, site not specified | 21 | 1.9% |
| Dural tear | 20 | 1.8% |
| Laparotomy | 20 | 1.8% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Ethicon | Product code GAG | All MAUDE reports |
|---|---|---|---|
| Reports | 1,100 | 26,848 | 26,136,888 |
| Share of that pool | — | 4.1% | 0% |
| Classified as death, per 1,000 reports | 23 | 10 | 9 |
| Classified as injury | 35.8% | 25.1% | 36.2% |
| Classified as malfunction | 54.2% | 72.9% | 62.3% |
| Filed by the manufacturer | 15.6% | 91.8% | 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 GAG
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Endopath Endoscopic Multifeed Stapler | 1,706 | 0 | 0% |
| Proximate Linear Cutter | 1,776 | 1 | 1.3% |
| Eea | 4,922 | 542 | 0.8% |
| Gia | 4,899 | 404 | 0.9% |
| Proximate I L S Intraluminal Stapler | 709 | 0 | 2% |
| Proximate Reloadable Linear Stapler | 1,025 | 0 | 1.4% |
| Endo Gia Universal 12mm Single Use Inst | 1,077 | 0 | 1.8% |
| Auto Suture Roticulator 55-4 8 | 451 | 0 | 0.2% |
| Proximate Access 55 Articulating Linear Stapler | 398 | 0 | 0.5% |
| Ta | 1,541 | 142 | 1% |
| Auto Suture Premium Plus Ceea 31mm | 357 | 0 | 0.3% |
| Auto Suture Roticulator 55 Poly - 200 | 353 | 0 | 0% |
| Auto Suture Roticulator 55-3 5 | 314 | 0 | 0.6% |
| Endopath Endoscopic Linear Cutter | 322 | 0 | 0% |
| Echelon | 1,352 | 584 | 3.2% |
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 Ethicon reports
How many FDA reports name Ethicon?
1,100 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 164 in the latest 12 months.
What kinds of events are reported?
malfunction (54.2%), injury (35.8%) and other (5.3%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
break (14.8%), replace (11%), failure to form staple (10%), misfire (10%) and failure to fire (6.1%). These are FDA's device problem codes as entered on the report.
Who files these reports?
voluntary reports (51.6%) and manufacturer reports (15.6%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Ethicon 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.