Ureteroscope and accessories, flexible/rigid: medical device reports filed with FDA

6,977 reports carry this product code, 1994–2026; 8 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.

6,977
reports with this product code: 0% of all MAUDE reports; 3,428
reports, 12 months to August 2026: 830 in the 12 months before; 89.3%
classified as malfunction: 62.3% across all reports; 0.1%
classified as death, as reported: 0.9% across all reports

Product code FGB is FDA's classification for "Ureteroscope and accessories, flexible/rigid" (gastroenterology, Urology panel), a class 2 device. 6,977 medical device reports carry this product code, 0% of the MAUDE database, from August 1994 to August 2026.

3,428 reports arrived in the 12 months to August 2026, up 313% from 830 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 (89.3%), injury (10.1%) and other (0.4%). 8 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
Uretero-Reno Videoscope	3,266	1,862	0%	96.1%
Uretero-Reno Fiberscope	1,774	1,053	0%	95.7%
Forceps/Irrigation Plug Isolated Type	356	2	0.8%	45.5%
Video Uretero-Renoscope FLEX-XC1	243	172	0%	90.5%
LithoVue	192	18	0%	64.6%
Karl Storz	3	0	2.1%	24.6%
Olympus	3	9	2.5%	69.7%
Endoeye Flex Deflectable Videoscope	1	2,245	0%	99.5%

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
Aizu Olympus	3,930	56.3%
Olympus Medical Systems	402	5.8%
Karl Storz Se & Kg	224	3.2%
Olympus Winter & Ibe	107	1.5%
Gyrus Acmi	75	1.1%
Richard Wolf	40	0.6%
Olympus Medical Systems Hinode Plant	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

Death0.1%7

Injury10.1%708

Malfunction89.3%6,227

Other0.4%28

Not given0.1%7

Who filed

Manufacturer report95.8%6,687

Voluntary report1%71

User facility report0%0

Distributor report1.5%105

Not given1.6%114

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

Device problems coded

Device problem (FDA code)	Reports	Share
Breakthe device broke	1,127	16.2%
Detachment of device or device componentpart of the device came off	945	13.5%
Loss of or failure to bond	520	7.5%
Failure to clean adequately	485	7%
Corrodedthe device corroded	325	4.7%
Microbial contamination of device	320	4.6%
Device reprocessing problem	300	4.3%
No display/image	233	3.3%
Peeled/delaminated	222	3.2%
Crackthe device cracked	190	2.7%
Material split, cut or torn	176	2.5%
Physical resistance/sticking	170	2.4%
Material deformation	164	2.4%
Mechanical problema mechanical problem	157	2.3%
Poor quality image	151	2.2%
Degraded	150	2.1%
Material fragmentation	132	1.9%
Material protrusion/extrusion	126	1.8%
Material separation	115	1.6%
Mechanical jam	113	1.6%

Questions about ureteroscope and accessories, flexible/rigid reports

What is product code FGB?

FDA's classification code for "Ureteroscope and accessories, flexible/rigid", 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?

6,977 reports through August 2026, 3,428 of them in the latest 12 months.

Which brands appear most often?

Uretero-Reno Videoscope (3,266), Uretero-Reno Fiberscope (1,774), Forceps/Irrigation Plug Isolated Type (356), Video Uretero-Renoscope FLEX-XC1 (243) and LithoVue (192). 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.