Reported Reactions

Devices › Stapler, surgical

Device brand name · Staplers - endoscopic

Endopath Endoscopic Multifeed Stapler: medical device reports filed with FDA

1,706 reports name it, 1996–2002. Manufacturer given most often on reports: Ethicon Endo-Surgery. Product code GAG.

1,706
device reports naming the brand
0% of all MAUDE reports · about 57 a year
0
reports, 12 months to August 2026
0 in the 12 months before
99.1%
classified as malfunction
72.9% across the product code
0%
classified as death, as reported
0 reports · not verified by FDA

1,706 medical device reports received by FDA name the brand "Endopath Endoscopic Multifeed Stapler" (staplers - endoscopic); the manufacturer given most often on reports is Ethicon Endo-Surgery; received from September 1996 to July 2002. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.

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 (99.1%) and injury (0.6%); 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 replace (52.3%), sticking (26.1%) and failure to form staple (16.1%). The patient problems coded most often are failure to anastomose, surgery, prolonged and foreign body, removal of. 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 Endoscopic Multifeed Stapler was received in the five years to August 2026; the latest was received in July 2002.

By year received

02284551996: 5719961997: 45519971998: 24019981999: 30619992000: 35620002001: 23920012002: 532002

Event type and report source

Event type, as classified on the report

Death0%0
Injury0.6%10
Malfunction99.1%1,690
Other0%0
Not given0.4%6

Who filed the report

Manufacturer report100%1,706
Voluntary report0%0
User facility report0%0
Distributor report0%0
Not given0%0

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)ReportsShareShare across product code
Replace89252.3%35.2%
Sticking44526.1%10.9%
Failure to form staple27516.1%27.4%
Misfire1659.7%8.9%
Failure to advance935.5%0.8%
Failure to fire875.1%8.9%
Failure to deliverthe device did not deliver the dose or item684%0.8%
Component missing523%3%
Close, difficult to342%0.7%
Malfunction251.5%0.9%
Device issuea problem with the device160.9%15.9%
Breakthe device broke120.7%1.9%
Failure, intermittent120.7%0.2%
Filling problem120.7%0.3%
Other (for use when an appropriate device code cannot be identified)80.5%1.2%
Clips, scissored70.4%0.5%
Device, removal of (non-implant)60.4%0.9%
Short fill60.4%0%
Detachment of device component40.2%1.8%
Inaccurate delivery40.2%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)ReportsShare
Failure to anastomose61135.8%
Surgery, prolonged251.5%
Foreign body, removal of201.2%
Surgical procedure, additional60.4%
Surgical procedure20.1%
Surgical procedure, delayed20.1%
Therapy/non-surgical treatment, additional20.1%
Bleeding10.1%
Hernia10.1%
Surgical procedure, repeated10.1%
Therapy/non-surgical treatment/delayed/prolonged10.1%

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

In context

MeasureEndopath Endoscopic Multifeed StaplerProduct code GAGAll MAUDE reports
Reports1,70626,84826,136,888
Share of that pool—6.4%0%
Classified as death, per 1,000 reports0109
Classified as injury0.6%25.1%36.2%
Classified as malfunction99.1%72.9%62.3%
Filed by the manufacturer100%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

BrandReportsLatest 12 monthsClassified as death
Proximate Linear Cutter1,77611.3%
Eea4,9225420.8%
Gia4,8994040.9%
Proximate I L S Intraluminal Stapler70902%
Proximate Reloadable Linear Stapler1,02501.4%
Endo Gia Universal 12mm Single Use Inst1,07701.8%
Auto Suture Roticulator 55-4 845100.2%
Proximate Access 55 Articulating Linear Stapler39800.5%
Ta1,5411421%
Auto Suture Premium Plus Ceea 31mm35700.3%
Auto Suture Roticulator 55 Poly - 20035300%
Auto Suture Roticulator 55-3 531400.6%
Endopath Endoscopic Linear Cutter32200%
Echelon1,3525843.2%
Proximate Linear Stapler57901.2%

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 Endopath Endoscopic Multifeed Stapler reports

How many FDA reports name Endopath Endoscopic Multifeed Stapler?

1,706 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 (99.1%) and injury (0.6%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

replace (52.3%), sticking (26.1%), failure to form staple (16.1%), misfire (9.7%) and failure to advance (5.5%). 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 Endoscopic Multifeed 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.