Device brand name · Circular staplers
Endopath Stealth Cir Stapler: medical device reports filed with FDA
301 reports name it, 2002–2021. Manufacturer given most often on reports: Ethicon Endo-Surgery.
- 301
- device reports naming the brand
- 0% of all MAUDE reports · about 12 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 75.4%
- classified as malfunction
- 62.3% across all reports
- 1.3%
- classified as death, as reported
- 4 reports · not verified by FDA
FDA's MAUDE database holds 301 reports that name the brand "Endopath Stealth Cir Stapler" (circular staplers), received between January 2002 and September 2021; the manufacturer given most often on reports is Ethicon Endo-Surgery. Spellings of one product vary from report to report.
0 reports arrived in the 12 months to August 2026, and none 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 (75.4%), injury (22.9%) and death (1.3%). 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 (18.3%), replace (13.6%) and break (10.6%). The patient problems coded most often are failure to anastomose, surgical procedure, additional and colostomy. 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 26,136,888 MAUDE reports. Event type is the filer's classification and is not verified by FDA.
Device problems coded
| Device problem (FDA code) | Reports | Share |
|---|---|---|
| Failure to form staple | 55 | 18.3% |
| Replace | 41 | 13.6% |
| Breakthe device broke | 32 | 10.6% |
| Difficult to removethe device was hard to remove | 24 | 8% |
| Detachment of device component | 23 | 7.6% |
| Insufficient device problem information | 19 | 6.3% |
| Leak/splashthe device leaked | 15 | 5% |
| Mechanics altered | 9 | 3% |
| Device operates differently than expectedthe device behaved unexpectedly | 8 | 2.7% |
| Failure to fire | 8 | 2.7% |
| Mechanical problema mechanical problem | 8 | 2.7% |
| Difficult to open or close | 7 | 2.3% |
| Component falling | 6 | 2% |
| Device difficult to setup or prepare | 6 | 2% |
| Difficult to insertthe device was hard to insert | 6 | 2% |
| Retraction problem | 6 | 2% |
| Failure to cut | 5 | 1.7% |
| Mechanical jam | 5 | 1.7% |
| Sticking | 5 | 1.7% |
| Bent | 4 | 1.3% |
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 |
|---|---|---|
| Failure to anastomose | 44 | 14.6% |
| Surgical procedure, additional | 16 | 5.3% |
| Colostomy | 11 | 3.7% |
| Hemorrhage/blood loss/bleeding | 10 | 3.3% |
| No patient involvement | 9 | 3% |
| Therapy/non-surgical treatment, additional | 9 | 3% |
| Laparotomy | 5 | 1.7% |
| Surgery, prolonged | 5 | 1.7% |
| Dural tear | 4 | 1.3% |
| Surgical procedure | 4 | 1.3% |
| Bleeding | 3 | 1% |
| Blood loss | 3 | 1% |
| Deaththe patient died; cause not stated by this term | 3 | 1% |
| Post operative wound infection | 3 | 1% |
| Foreign body, removal of | 2 | 0.7% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Endopath Stealth Cir Stapler | All MAUDE reports |
|---|---|---|
| Reports | 301 | 26,136,888 |
| Share of that pool | — | 0% |
| Classified as death, per 1,000 reports | 13 | 9 |
| Classified as injury | 22.9% | 36.2% |
| Classified as malfunction | 75.4% | 62.3% |
| Filed by the manufacturer | 100% | 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."
Questions about Endopath Stealth Cir Stapler reports
How many FDA reports name Endopath Stealth Cir Stapler?
301 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 0 in the latest 12 months.
What kinds of events are reported?
malfunction (75.4%), injury (22.9%) and death (1.3%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
failure to form staple (18.3%), replace (13.6%), break (10.6%), difficult to remove (8%) and detachment of device component (7.6%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (100%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Endopath Stealth Cir Stapler 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.