Device brand name · Endoscope and/or accessories

Endo Stitch 10mm Suturing Device: medical device reports filed with FDA

1,638 reports name it, 2001–2017. Manufacturer given most often on reports: Covidien.

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.

1,638
device reports naming the brand: 0% of all MAUDE reports · about 66 a year; 0
reports, 12 months to August 2026: 0 in the 12 months before; 84.4%
classified as malfunction: 62.3% across all reports; 0%
classified as death, as reported: 0 reports · not verified by FDA

1,638 medical device reports received by FDA name the brand "Endo Stitch 10mm Suturing Device" (endoscope and/or accessories); the manufacturer given most often on reports is Covidien; received from September 2001 to March 2017. 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 (84.4%) and injury (15.3%). Event type is the reporter's classification of the report, not a verified outcome.

The device problems coded most often are detachment of device component (35.2%), break (23.3%) and detachment of device or device component (10.1%). The patient problems coded most often are device embedded in tissue or plaque, hemorrhage/blood loss/bleeding and tissue damage. 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 Endo Stitch 10mm Suturing Device was received in the five years to August 2026; the latest was received in March 2017.

By year received

Event type and report source

Event type, as classified on the report

Death0%0

Injury15.3%250

Malfunction84.4%1,382

Other0%0

Not given0.4%6

Who filed the report

Manufacturer report99.9%1,637

Voluntary report0%0

User facility report0%0

Distributor report0%0

Not given0.1%1

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
Detachment of device component	577	35.2%
Breakthe device broke	382	23.3%
Detachment of device or device componentpart of the device came off	165	10.1%
Component falling	164	10%
Difficult to open or close	109	6.7%
Device operates differently than expectedthe device behaved unexpectedly	90	5.5%
Sticking	84	5.1%
Human-device interface problem	74	4.5%
Mechanical jam	65	4%
Difficult to removethe device was hard to remove	55	3.4%
Replace	55	3.4%
Component(s), broken	45	2.7%
Device, removal of (non-implant)	44	2.7%
Device or device fragments location unknown	43	2.6%
Device, or device fragments remain in patient	43	2.6%
Device slipped	42	2.6%
Bent	34	2.1%
Device difficult to setup or prepare	31	1.9%
Mechanical problema mechanical problem	30	1.8%
Needle, separation	24	1.5%

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
Device embedded in tissue or plaque	100	6.1%
Hemorrhage/blood loss/bleeding	98	6%
Tissue damage	89	5.4%
Foreign body, removal of	75	4.6%
Nonresorbable materials, unretrieved in body	48	2.9%
Therapy/non-surgical treatment, additional	30	1.8%
Surgery, prolonged	18	1.1%
Foreign body in patientpart of a device left in the patient	17	1%
Blood loss	13	0.8%
No patient involvement	13	0.8%
Injurya physical injury	9	0.5%
Surgical procedure	9	0.5%
Radiation exposure, unintended	8	0.5%
Surgical procedure, additional	8	0.5%
Failure to anastomose	7	0.4%

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

In context

Measure	Endo Stitch 10mm Suturing Device	All MAUDE reports
Reports	1,638	26,136,888
Share of that pool	—	0%
Classified as death, per 1,000 reports	0	9
Classified as injury	15.3%	36.2%
Classified as malfunction	84.4%	62.3%
Filed by the manufacturer	99.9%	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 Endo Stitch 10mm Suturing Device reports

How many FDA reports name Endo Stitch 10mm Suturing Device?

1,638 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 (84.4%) and injury (15.3%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

detachment of device component (35.2%), break (23.3%), detachment of device or device component (10.1%), component falling (10%) and difficult to open or close (6.7%). These are FDA's device problem codes as entered on the report.

Who files these reports?

manufacturer reports (99.9%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.

Do these reports show that Endo Stitch 10mm Suturing Device 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.