Electrode, electrosurgical, active, urological: medical device reports filed with FDA

2,390 reports carry this product code, 1992–2026; 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.

2,390
reports with this product code: 0% of all MAUDE reports; 407
reports, 12 months to August 2026: 377 in the 12 months before; 78.7%
classified as malfunction: 62.3% across all reports; 0.2%
classified as death, as reported: 0.9% across all reports

Product code FAS is FDA's classification for "Electrode, electrosurgical, active, urological" (gastroenterology, Urology panel), a class 2 device. 2,390 medical device reports carry this product code, 0% of the MAUDE database, from July 1992 to August 2026.

407 reports arrived in the 12 months to August 2026, close to the 377 of 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 (78.7%), injury (19.4%) and other (1.5%). 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
HF-resection electrode, loop, 24 Fr., 0.2 wire, medium, 12	228	101	0%	84.6%
Electrode, bipolar	144	104	0%	53.7%
Olympus	18	9	2.5%	69.7%
Inner sheath, for 26 Fr. outer sheath	1	533	0%	90.9%
Karl Storz	1	0	2.1%	24.6%

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	848	35.5%
Karl Storz Se & Kg	492	20.6%
Gyrus Acmi	113	4.7%
Richard Wolf	74	3.1%
Olympus Medical System	4	0.2%
Olympus Winter & Ibe Berlin Facility	3	0.1%
Productos Para El Cuidado De La Salud -9611590	3	0.1%
Conmed	2	0.1%
American Medical Systems	1	0%
C R Bard Covington	1	0%
Keymed Medical And Industrial Equipment	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%4

Injury19.4%463

Malfunction78.7%1,881

Other1.5%36

Not given0.3%6

Who filed

Manufacturer report86.4%2,065

Voluntary report3.4%82

User facility report0%0

Distributor report5.7%136

Not given4.5%107

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

Device problems coded

Device problem (FDA code)	Reports	Share
Breakthe device broke	1,180	49.4%
Detachment of device or device componentpart of the device came off	253	10.6%
Material fragmentation	163	6.8%
Fracturea broken bone	145	6.1%
Sparking	123	5.1%
Mechanical problema mechanical problem	113	4.7%
Melted	99	4.1%
Material twisted/bent	83	3.5%
Detachment of device component	81	3.4%
Material separation	55	2.3%
Thermal decomposition of device	51	2.1%
Material deformation	42	1.8%
Component falling	36	1.5%
Overheating of device	35	1.5%
Insufficient device problem information	30	1.3%
Arcing	28	1.2%
Replace	28	1.2%
Crackthe device cracked	23	1%
Tip breakage	22	0.9%
Electrode(s), fracture of	21	0.9%

Questions about electrode, electrosurgical, active, urological reports

What is product code FAS?

FDA's classification code for "Electrode, electrosurgical, active, urological", 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?

2,390 reports through August 2026, 407 of them in the latest 12 months.

Which brands appear most often?

HF-resection electrode, loop, 24 Fr., 0.2 wire, medium, 12 (228), Electrode, bipolar (144), Olympus (18), Inner sheath, for 26 Fr. outer sheath (1) and Karl Storz (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.