Snare, flexible: medical device reports filed with FDA

4,658 reports carry this product code, 1994–2026; 13 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.

4,658
reports with this product code: 0% of all MAUDE reports; 347
reports, 12 months to August 2026: 280 in the 12 months before; 86.4%
classified as malfunction: 62.3% across all reports; 0.2%
classified as death, as reported: 0.9% across all reports

Product code FDI is FDA's classification for "Snare, flexible" (gastroenterology, Urology panel), a class 2 device. 4,658 medical device reports carry this product code, 0% of the MAUDE database, from February 1994 to August 2026.

347 reports arrived in the 12 months to August 2026, up 24% from 280 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 (86.4%), injury (12.8%) and other (0.3%). 13 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
SENSATION Short Throw	731	83	0%	93.3%
Captivator	508	29	0%	90.6%
Rotatable Snare	486	20	0%	97.7%
Captiflex	400	13	0%	94.3%
Ultratome XL	400	38	0.5%	97.3%
ACUSNARE Polypectomy Snare	111	13	0%	88.1%
Hydratome Rx Sphincterotome	10	0	0.2%	96.7%
Boston Scientific	3	5	3.3%	55%
Fresenius	3	0	6.1%	13.7%
NCircle Tipless Stone Extractor	2	232	0%	93%
Prisma Control Unit	2	0	6%	56%
Conmed	1	89	0.2%	65.6%
Optiflux 180nre Dialyzer Finished Assy	1	69	0.6%	85.3%

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
Boston Scientific - Costa Rica Coyol	1,214	26.1%
Boston Scientific - Costa Rica	213	4.6%
Wilson-Cook Medical	120	2.6%
Boston Scientific - Spencer	92	2%
Cook Endoscopy	57	1.2%
Conmed	21	0.5%
Olympus Medical Systems	10	0.2%
Boston Scientific	8	0.2%
Consolidated Medical Equipment	5	0.1%
Ev3	5	0.1%
Bard	4	0.1%
Olympus Optical	3	0.1%
Cook Ireland	1	0%
Kimberly-Clark	1	0%

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

Death0.2%10

Injury12.8%594

Malfunction86.4%4,023

Other0.3%16

Not given0.3%15

Who filed

Manufacturer report95%4,427

Voluntary report2.1%98

User facility report0%0

Distributor report0.3%13

Not given2.6%120

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

Device problems coded

Device problem (FDA code)	Reports	Share
Failure to cut	1,139	24.5%
Breakthe device broke	713	15.3%
Detachment of device component	637	13.7%
Failure to deliver energy	503	10.8%
Entrapment of device	214	4.6%
Retraction problem	183	3.9%
Unsealed device packaging	166	3.6%
Detachment of device or device componentpart of the device came off	159	3.4%
Electrical /electronic property probleman electrical or electronic problem	113	2.4%
Difficult to open or close	105	2.3%
Replace	105	2.3%
Other (for use when an appropriate device code cannot be identified)	94	2%
Positioning problem	87	1.9%
Wire(s), breakage of	72	1.5%
Difficult to removethe device was hard to remove	71	1.5%
Mechanical problema mechanical problem	71	1.5%
Component(s), broken	70	1.5%
Material twisted/bent	70	1.5%
Device contamination with chemical or other material	66	1.4%
Material deformation	65	1.4%

Questions about snare, flexible reports

What is product code FDI?

FDA's classification code for "Snare, flexible", 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?

4,658 reports through August 2026, 347 of them in the latest 12 months.

Which brands appear most often?

SENSATION Short Throw (731), Captivator (508), Rotatable Snare (486), Captiflex (400) and Ultratome XL (400). 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.