Stapler, surgical: medical device reports filed with FDA

26,848 reports carry this product code, 1992–2026; 30 brands with a page.

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.

26,848
reports with this product code: 0.1% of all MAUDE reports; 1,451
reports, 12 months to August 2026: 1,015 in the 12 months before; 72.9%
classified as malfunction: 62.3% across all reports; 1%
classified as death, as reported: 0.9% across all reports

Product code GAG is FDA's classification for "Stapler, surgical" (general Hospital panel), a class 2 device. 26,848 medical device reports carry this product code, 0.1% of the MAUDE database, from March 1992 to August 2026.

1,451 reports arrived in the 12 months to August 2026, up 43% from 1,015 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 (72.9%), injury (25.1%) and death (1%). 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

Brand	Reports	Latest 12 months	Classified as death	Classified as malfunction
Endopath Endoscopic Multifeed Stapler	1,703	0	0%	99.1%
Proximate Linear Cutter	1,459	1	1.3%	89.6%
Eea	1,298	542	0.8%	58.4%
Gia	1,131	404	0.9%	79.9%
Proximate I L S Intraluminal Stapler	708	0	2%	76.9%
Proximate Reloadable Linear Stapler	565	0	1.4%	85.2%
Endo Gia Universal 12mm Single Use Inst	465	0	1.8%	1.6%
Auto Suture Roticulator 55-4 8	451	0	0.2%	78.9%
Proximate Access 55 Articulating Linear Stapler	396	0	0.5%	79.9%
Ta	368	142	1%	76.4%
Auto Suture Premium Plus Ceea 31mm	357	0	0.3%	73.9%
Auto Suture Roticulator 55 Poly - 200	353	0	0%	94.9%
Auto Suture Roticulator 55-3 5	314	0	0.6%	76.8%
Endopath Endoscopic Linear Cutter	314	0	0%	92.9%
Echelon	310	584	3.2%	72.8%
Proximate Linear Stapler	299	0	1.2%	85.3%
Endopath Thoracic Endoscopic Linear Cutter With Safety	292	0	0%	90.4%
Premium Plus Ceea 31 Instr W/Tilt-Top	284	0	1.1%	0.7%
Proximate Ils Curved Cir Stapl	267	0	0.7%	69.4%
Proximate Proximate I L S Curved Intraluminal Staple	249	0	1.2%	62.2%
Endopath Endoscopic Vascular Linear Cutter	228	0	0%	87.8%
Auto Suture Multifire Gia 60-3 8	225	0	0.9%	93.4%
Ethicon	223	164	2.3%	54.2%
Proximate Ils Circular Staplers	223	0	0%	69.6%
Auto Suture Premium Plus Ceea 28mm	217	0	0%	83.9%
Endopath Thoracic Endo Linear Cutter W/Safety Lock	190	0	0%	92.7%
Auto Suture Multifire Gia 80-3 8	186	0	0.5%	90.9%
Auto Suture Roticulator 55 Poly 200	178	0	0%	96.1%
Proximate Linear Cutter Reloading Unit With Safety Lock	168	0	5.1%	83.5%
Eea 31mm Single-Use Stapler	156	0	1.1%	0.7%

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
United States Surgical	6,759	25.2%
Ethicon Endo-Surgery	6,299	23.5%
Ethicon Endo-Surgery - Alb	1,902	7.1%
Ethicon Endo-Surgery Cincinnati	1,517	5.7%
US Surgical Puerto Rico	1,478	5.5%
Ponce - Uss	1,397	5.2%
North Haven - Uss	1,157	4.3%
Covidien	1,046	3.9%
Ethicon Endo Surgery Cincinnati	883	3.3%
Ethicon Endo-Surgery De C V	344	1.3%
Ethicon Endo Surgery	263	1%
Covidien North Haven	221	0.8%
Covidien Surgical	207	0.8%
Power Medical Interventions	156	0.6%
Covidien Formerly Ussc Puerto Rico	140	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

Death1%278

Injury25.1%6,735

Malfunction72.9%19,572

Other0.4%120

Not given0.5%143

Who filed

Manufacturer report91.8%24,636

Voluntary report3.7%998

User facility report0%0

Distributor report0%3

Not given4.5%1,211

Grey bar: all 26,136,888 MAUDE reports.

Device problems coded

Device problem (FDA code)	Reports	Share
Replace	9,441	35.2%
Failure to form staple	7,348	27.4%
Device issuea problem with the device	4,282	15.9%
Sticking	2,916	10.9%
Misfire	2,391	8.9%
Failure to fire	2,379	8.9%
Difficult to removethe device was hard to remove	1,539	5.7%
Failure to cut	959	3.6%
Component missing	812	3%
Breakthe device broke	510	1.9%
Detachment of device component	494	1.8%
Leak/splashthe device leaked	414	1.5%
Detachment of device or device componentpart of the device came off	354	1.3%
Mechanical problema mechanical problem	351	1.3%
Other (for use when an appropriate device code cannot be identified)	319	1.2%
Failure to adhere or bond	318	1.2%
Component(s), broken	296	1.1%
Malfunction	254	0.9%
Device, removal of (non-implant)	235	0.9%
Difficult to open or close	221	0.8%

Questions about stapler, surgical reports

What is product code GAG?

FDA's classification code for "Stapler, surgical", class 2, reviewed by the general Hospital panel. Every device report carries the product code of the device involved.

How many reports carry this code?

26,848 reports through August 2026, 1,451 of them in the latest 12 months.

Which brands appear most often?

Endopath Endoscopic Multifeed Stapler (1,703), Proximate Linear Cutter (1,459), Eea (1,298), Gia (1,131) and Proximate I L S Intraluminal Stapler (708). 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.