Unit, electrosurgical, endoscopic (with or without accessories): medical device reports filed with FDA

17,476 reports carry this product code, 1994–2026; 30 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.

17,476
reports with this product code: 0.1% of all MAUDE reports; 1,755
reports, 12 months to August 2026: 1,397 in the 12 months before; 77.6%
classified as malfunction: 62.3% across all reports; 0.5%
classified as death, as reported: 0.9% across all reports

Product code KNS is FDA's classification for "Unit, electrosurgical, endoscopic (with or without accessories)" (gastroenterology, Urology panel), a class 2 device. 17,476 medical device reports carry this product code, 0.1% of the MAUDE database, from March 1994 to August 2026.

1,755 reports arrived in the 12 months to August 2026, up 26% from 1,397 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 (77.6%), injury (20.9%) and other (0.8%). 30 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
Single Use 3-Lumen Sphincterotome V	1,748	256	0.2%	95.7%
Rezum	1,286	524	0.9%	27.9%
Single Use Electrosurgical Knife	904	52	0.5%	43.9%
Injection Gold Probe	581	12	0.2%	91.6%
Fusion Omni-Tome Pre-Loaded Sphincterotome	501	0	0%	98.4%
Autotome RX 44	481	62	0.2%	96.9%
Fusion Omni-Tome	452	15	0%	97.6%
Hydratome Rx Sphincterotome	448	0	0.2%	96.7%
Autotome Rx Sphincterotome	440	0	0.5%	95.9%
Dreamtome RX 44	439	34	0.5%	95.7%
TRUEtome 44	394	80	0%	99%
Hydratome RX 44	296	10	0%	95.6%
Tri-Tome Pc Triple Lumen Sphincterotome	254	0	0%	92.9%
Endostat 3 Bipolar/Monopolar Electrosurgical Generator	237	0	0%	98.3%
Axios?	236	224	1.5%	51%
Gold Probe	232	15	0%	86.9%
Endostat Electrosurgical Unit	230	0	0%	91.3%
Jagtome RX 44	218	19	0%	95.4%
Fusion Pre-Loaded With Acrobat Wire Guide	207	0	0%	97.6%
ACUSNARE Polypectomy Snare	205	13	0%	88.1%
D A S H Dometip Double Lumen Sphincterotome	189	0	0%	76.2%
Fusion Omni-Tome Sphincterotome	185	0	0%	97.8%
Single Use Electrosurgical Knife KD-650	174	23	1.7%	23%
AXIOS Stent and Electrocautery Enhanced Delivery System	169	495	3.5%	48.9%
Single Use Electrosurgical Hemostatic Forceps	167	9	0.6%	43.8%
Prostiva	166	0	2.4%	58.1%
Jagtome Rx Sphincterotome	156	0	0%	98.7%
RX Needle Knife XL	151	14	0%	56.3%
Ultracision Surg Dev Shears Endoscopic	64	0	0%	92.9%
Olympus	57	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
Aomori Olympus	2,112	12.1%
Cook Endoscopy	1,425	8.2%
Boston Scientific	1,350	7.7%
Wilson-Cook Medical	1,179	6.7%
Boston Scientific - Spencer	931	5.3%
Olympus Medical Systems	638	3.7%
Boston Scientific - Costa Rica Coyol	561	3.2%
Boston Scientific - Marlborough	529	3%
Ethicon Endo-Surgery - Alb	221	1.3%
Ethicon Endo-Surgery	215	1.2%
Cook Ireland	199	1.1%
Olympus Winter & Ibe	171	1%
Medtronic Neuromodulation	67	0.4%
Ethicon Endo-Surgery Cincinnati	59	0.3%
Ethicon Endo Surgery Cincinnati	50	0.3%

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

Death0.5%81

Injury20.9%3,653

Malfunction77.6%13,555

Other0.8%144

Not given0.2%43

Who filed

Manufacturer report96.3%16,833

Voluntary report1.5%268

User facility report0%0

Distributor report0.4%67

Not given1.8%308

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

Device problems coded

Device problem (FDA code)	Reports	Share
Breakthe device broke	4,973	28.5%
Failure to align	789	4.5%
Failure to deliver energy	715	4.1%
Replace	597	3.4%
Detachment of device or device componentpart of the device came off	564	3.2%
Material separation	553	3.2%
Detachment of device component	441	2.5%
Other (for use when an appropriate device code cannot be identified)	405	2.3%
Retraction problem	392	2.2%
Positioning problem	323	1.8%
Material deformation	299	1.7%
Tip breakage	286	1.6%
Peeled/delaminated	274	1.6%
Malposition of device	251	1.4%
Bent	245	1.4%
Failure to conduct	220	1.3%
Wire(s), breakage of	217	1.2%
Electrical /electronic property probleman electrical or electronic problem	211	1.2%
Material split, cut or torn	191	1.1%
Component(s), broken	183	1%

Questions about unit, electrosurgical, endoscopic (with or without accessories) reports

What is product code KNS?

FDA's classification code for "Unit, electrosurgical, endoscopic (with or without accessories)", 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?

17,476 reports through August 2026, 1,755 of them in the latest 12 months.

Which brands appear most often?

Single Use 3-Lumen Sphincterotome V (1,748), Rezum (1,286), Single Use Electrosurgical Knife (904), Injection Gold Probe (581) and Fusion Omni-Tome Pre-Loaded Sphincterotome (501). 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.