Device brand name · Linear cutters - endoscopic

Endopath Ets: medical device reports filed with FDA

1,641 reports name it, 1996–2016. Manufacturer given most often on reports: Ethicon Endo-Surgery.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "Although MDRs are a valuable source of information, this passive surveillance system has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting of events and lack of information about frequency of device use." And: "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."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

1,641
device reports naming the brand: 0% of all MAUDE reports · about 55 a year; 0
reports, 12 months to August 2026: 0 in the 12 months before; 89.6%
classified as malfunction: 62.3% across all reports; 0.2%
classified as death, as reported: 4 reports · not verified by FDA

FDA's MAUDE database holds 1,641 reports that name the brand "Endopath Ets" (linear cutters - endoscopic), received between October 1996 and November 2016; 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 (89.6%), injury (9.6%) and death (0.2%). Event type is the reporter's classification of the report, not a verified outcome.

The device problems coded most often are replace (48%), failure to form staple (22.6%) and sticking (16.4%). The patient problems coded most often are failure to anastomose, surgical procedure, additional and 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

No report naming Endopath Ets was received in the five years to August 2026; the latest was received in November 2016.

By year received

Event type and report source

Event type, as classified on the report

Death0.2%4

Injury9.6%158

Malfunction89.6%1,471

Other0%0

Not given0.5%8

Who filed the report

Manufacturer report97.7%1,603

Voluntary report0%0

User facility report0%0

Distributor report0%0

Not given2.3%38

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
Replace	788	48%
Failure to form staple	371	22.6%
Sticking	269	16.4%
Misfire	254	15.5%
Failure to fire	141	8.6%
Dislodged	73	4.4%
Failure to adhere or bond	48	2.9%
Failure to cut	47	2.9%
Difficult to removethe device was hard to remove	36	2.2%
Detachment of device component	33	2%
Device slipped	29	1.8%
Other (for use when an appropriate device code cannot be identified)	27	1.6%
Material separation	26	1.6%
Breakthe device broke	25	1.5%
Device issuea problem with the device	23	1.4%
Close, difficult to	21	1.3%
Mechanical problema mechanical problem	21	1.3%
Failure to deliverthe device did not deliver the dose or item	20	1.2%
Suture line disruption	17	1%
Suture line separation	14	0.9%

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	493	30%
Surgical procedure, additional	105	6.4%
Bleeding	93	5.7%
Surgery, prolonged	90	5.5%
Tissue damage	35	2.1%
Surgical procedure	19	1.2%
Surgical procedure, repeated	19	1.2%
Therapy/non-surgical treatment, additional	19	1.2%
Foreign body, removal of	18	1.1%
Blood loss	13	0.8%
Hospitalization required	12	0.7%
Other (for use when an appropriate patient code cannot be identified)	10	0.6%
Laparotomy	9	0.5%
Hemorrhage/blood loss/bleeding	5	0.3%
Wound dehiscencea wound reopened	5	0.3%

Patient problem codes are present mainly in reports filed since 2019 and are often blank.

In context

Measure	Endopath Ets	All MAUDE reports
Reports	1,641	26,136,888
Share of that pool	—	0%
Classified as death, per 1,000 reports	2	9
Classified as injury	9.6%	36.2%
Classified as malfunction	89.6%	62.3%
Filed by the manufacturer	97.7%	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 Ets reports

How many FDA reports name Endopath Ets?

1,641 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 (89.6%), injury (9.6%) and death (0.2%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

replace (48%), failure to form staple (22.6%), sticking (16.4%), misfire (15.5%) and failure to fire (8.6%). These are FDA's device problem codes as entered on the report.

Who files these reports?

manufacturer reports (97.7%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.

Do these reports show that Endopath Ets 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.