Endoscopic tissue approximation device: medical device reports filed with FDA

3,206 reports carry this product code, 2004–2026; 18 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.

3,206
reports with this product code: 0% of all MAUDE reports; 486
reports, 12 months to August 2026: 285 in the 12 months before; 72.1%
classified as malfunction: 62.3% across all reports; 0.5%
classified as death, as reported: 0.9% across all reports

Product code OCW is FDA's classification for "Endoscopic tissue approximation device" (gastroenterology, Urology panel), a class 2 device. 3,206 medical device reports carry this product code, 0% of the MAUDE database, from July 2004 to August 2026.

486 reports arrived in the 12 months to August 2026, up 71% from 285 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 (72.1%), injury (27%) and death (0.5%). 18 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
Endo Stitch	1,456	64	0.1%	79.4%
Surgidac	202	4	0%	76.8%
Polysorb	190	1,836	0%	86%
OverStitch Suture Cinch	166	142	0%	45.8%
Endo Stitch 10mm Suturing Device	79	0	0%	84.4%
Unknown Endo Stitch SULU	57	17	0%	73.7%
Sofsilk	37	49	0%	91%
Endopath Ils Endoscopic Curved Intraluminal Stapler - 29 Mm	34	0	1.1%	65.4%
Protack 5mm Instrument	15	0	1.6%	32.7%
Endopath Stealth Cir Stapler	11	0	1.3%	75.4%
Ligaclip Endoscopic Rotating Multiple Clip Applier	4	0	0.1%	96.4%
AbsorbaTack	2	165	0%	92.8%
Protack	2	44	0.1%	90%
Auto Suture	1	234	0.1%	94.6%
McGRATH	1	89	1.8%	93.3%
Orbera Intragastric Balloon System	1	10	2.5%	62.8%
V-Loc	1	72	0%	88.8%
V-Loc 180	1	678	0%	86.1%

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
Davis & Geck Caribe	1,759	54.9%
Apollo Endosurgery	399	12.4%
Ethicon Endo-Surgery	84	2.6%
Covidien North Haven	32	1%
Covidien Formerly Ussc Puerto Rico	8	0.2%
Covidien Surgical	5	0.2%
Ethicon Endo Surgery Cincinnati	4	0.1%
Covidien Mfg Dc Boulder	2	0.1%
Davol Sub C R Bard	2	0.1%
Ethicon Endo-Surgery Cincinnati	2	0.1%
US Surgical Puerto Rico	2	0.1%

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

Death0.5%15

Injury27%865

Malfunction72.1%2,310

Other0.1%4

Not given0.4%12

Who filed

Manufacturer report85.8%2,750

Voluntary report4.4%141

User facility report0%0

Distributor report0%0

Not given9.8%315

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

Device problems coded

Device problem (FDA code)	Reports	Share
Breakthe device broke	1,059	33%
Detachment of device or device componentpart of the device came off	866	27%
Human-device interface problem	582	18.2%
Detachment of device component	415	12.9%
Component or accessory incompatibility	183	5.7%
Difficult to open or close	131	4.1%
Activation failure	129	4%
Failure to cut	78	2.4%
Entrapment of device	76	2.4%
Mechanical jam	68	2.1%
Material twisted/bent	65	2%
Difficult to removethe device was hard to remove	62	1.9%
Device-device incompatibility	56	1.7%
Mechanical problema mechanical problem	56	1.7%
Failure to form staple	52	1.6%
Insufficient device problem information	48	1.5%
Device operates differently than expectedthe device behaved unexpectedly	47	1.5%
Failure to fire	43	1.3%
Failure to align	39	1.2%
Replace	36	1.1%

Questions about endoscopic tissue approximation device reports

What is product code OCW?

FDA's classification code for "Endoscopic tissue approximation device", class 2, reviewed by the gastroenterology, Urology panel. Every device report carries the product code of the device involved.

How many reports carry this code?

3,206 reports through August 2026, 486 of them in the latest 12 months.

Which brands appear most often?

Endo Stitch (1,456), Surgidac (202), Polysorb (190), OverStitch Suture Cinch (166) and Endo Stitch 10mm Suturing Device (79). 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.