Endoscopic access overtube, gastroenterology-urology: medical device reports filed with FDA

1,322 reports carry this product code, 1995–2026; 5 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.

1,322
reports with this product code: 0% of all MAUDE reports; 111
reports, 12 months to August 2026: 96 in the 12 months before; 72.1%
classified as malfunction: 62.3% across all reports; 1.7%
classified as death, as reported: 0.9% across all reports

Product code FED is FDA's classification for "Endoscopic access overtube, gastroenterology-urology" (gastroenterology, Urology panel), a class 2 device. 1,322 medical device reports carry this product code, 0% of the MAUDE database, from June 1995 to August 2026.

111 reports arrived in the 12 months to August 2026, up 16% from 96 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 (18.9%) and other (5.2%). 5 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
Navigator Hd	150	3	0.6%	71.1%
Karl Storz	34	0	2.1%	24.6%
Inner sheath, for 26 Fr. outer sheath	12	533	0%	90.9%
Resection sheath, 24 Fr.	11	170	0.1%	88.4%
Olympus	1	9	2.5%	69.7%

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
Olympus Winter & Ibe	84	6.4%
Ethicon	50	3.8%
Gyrus Acmi	24	1.8%
Richard Wolf	15	1.1%
Coloplast A/S	13	1%
Keymed Medical And Industrial Equipment	13	1%
Olympus Medical Systems Hinode Plant	11	0.8%
Apollo Endosurgery	10	0.8%
Applied Medical Resources	8	0.6%
Applied Medical	5	0.4%
C R Bard Covington	1	0.1%
Medtronic Xomed	1	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

Death1.7%22

Injury18.9%250

Malfunction72.1%953

Other5.2%69

Not given2.1%28

Who filed

Manufacturer report84.1%1,112

Voluntary report3.9%51

User facility report0%0

Distributor report6.1%81

Not given5.9%78

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

Device problems coded

Device problem (FDA code)	Reports	Share
Tip breakage	257	19.4%
Breakthe device broke	208	15.7%
Detachment of device component	128	9.7%
Peeled/delaminated	84	6.4%
Difficult to insertthe device was hard to insert	63	4.8%
Material separation	54	4.1%
Material split, cut or torn	51	3.9%
Device, or device fragments remain in patient	48	3.6%
Difficult to removethe device was hard to remove	36	2.7%
Replace	35	2.6%
Component(s), broken	30	2.3%
Detachment of device or device componentpart of the device came off	30	2.3%
Device contamination with chemical or other material	30	2.3%
Device, removal of (non-implant)	29	2.2%
Material integrity problema problem with the device material	27	2%
Component falling	23	1.7%
Material deformation	20	1.5%
Material fragmentation	19	1.4%
Unsealed device packaging	19	1.4%
Insufficient device problem information	17	1.3%

Questions about endoscopic access overtube, gastroenterology-urology reports

What is product code FED?

FDA's classification code for "Endoscopic access overtube, gastroenterology-urology", 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?

1,322 reports through August 2026, 111 of them in the latest 12 months.

Which brands appear most often?

Navigator Hd (150), Karl Storz (34), Inner sheath, for 26 Fr. outer sheath (12), Resection sheath, 24 Fr. (11) and Olympus (1). 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.