Device manufacturer, as written on reports

Cook Endoscopy: medical device reports filed with FDA

5,830 reports name it as the manufacturer of the device involved, 2005–2022.

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.

5,830
reports naming it as manufacturer: 0% of all MAUDE reports; 0
reports, 12 months to August 2026: 0 in the 12 months before; 85%
classified as malfunction: 62.3% across all reports; 0.3%
classified as death, as reported: 0.9% across all reports

5,830 medical device reports received by FDA give Cook Endoscopy as the manufacturer of the device involved, 0% of the MAUDE database, from November 2005 to September 2022. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

0 reports arrived in the 12 months to August 2026, and none 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 (85%), injury (14.5%) and death (0.3%). Manufacturers are required to report events they learn of, so a large manufacturer with many products in use files many reports. 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 named most often

Brand	Device type	Reports	Latest 12 months	Classified as death
6 Shooter Saeed Multi-Band Ligator	Ligator, esophageal	579	92	0.1%
Hemospray Endoscopic Hemostat	Hemostatic device for endoscopic gastrointestinal use	476	116	0.9%
Hercules 3 Stage Wireguided Balloon Esophageal-Pyloric-Colonic	Dilator, esophageal	307	46	0%
Instinct Endoscopic Hemoclip	Hemostatic metal clip for the gi tract	291	0	0.1%
Instinct Plus Endoscopic Clipping Device	Hemostatic metal clip for the gi tract	230	229	0%
Fusion Omni-Tome	Unit, electrosurgical, endoscopic (with or without accessories)	224	15	0%
Fusion Omni-Tome Pre-Loaded Sphincterotome	Unit, electrosurgical, endoscopic (with or without accessories)	208	0	0%
ACUSNARE Polypectomy Snare	Unit, electrosurgical, endoscopic (with or without accessories)	186	13	0%
Captura Serrated Forceps With Spike	Forceps, biopsy, non-electric	177	0	0%
Hercules 3 Stage Balloon Esophageal	Dilator, esophageal	171	7	0%
Tri-Tome Pc Triple Lumen Sphincterotome	Unit, electrosurgical, endoscopic (with or without accessories)	169	0	0%
Fusion Omni-Tome Sphincterotome	Unit, electrosurgical, endoscopic (with or without accessories)	151	0	0%
Fusion Pre-Loaded With Acrobat Wire Guide	Unit, electrosurgical, endoscopic (with or without accessories)	133	0	0%
Acrobat Calibrated Tip Wire Guide	Endoscopic guidewire, gastroenterology-urology	120	0	0%
D A S H Dometip Double Lumen Sphincterotome	Unit, electrosurgical, endoscopic (with or without accessories)	92	0	0%
Quantum Ttc Esophageal Balloon Dilator	Dilator, esophageal	59	0	0%
Echotip Ultra Endoscopic Ultrasound Needle	Biopsy needle	40	49	0%
Disposable Biopsy Forceps	Forceps, biopsy, non-electric	6	8	0%
Cotton-Leung Biliary Stent	Stents, drains and dilators for the biliary ducts	2	20	1.1%

Brands with a page on this site, 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."

Device types

Product code	Device type	Reports	Share
KNS	Unit, electrosurgical, endoscopic (with or without accessories)	1,425	24.4%
MND	Ligator, esophageal	706	12.1%
KNQ	Dilator, esophageal	681	11.7%
PKL	Hemostatic metal clip for the gi tract	517	8.9%
QAU	Hemostatic device for endoscopic gastrointestinal use	472	8.1%
FCL	Forceps, biopsy, non-electric	464	8%
OCY	Endoscopic guidewire, gastroenterology-urology	252	4.3%
FGE	Stents, drains and dilators for the biliary ducts	220	3.8%
FFL	Dislodger, stone, basket, ureteral, metal	180	3.1%
KNT	Tubes, gastrointestinal (and accessories)	126	2.2%

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

Death0.3%20

Injury14.5%846

Malfunction85%4,956

Other0%1

Not given0.1%7

Grey bar: all 26,136,888 MAUDE reports. Event type is the filer's classification and is not verified by FDA.

Questions about Cook Endoscopy reports

How many FDA device reports name Cook Endoscopy as manufacturer?

5,830 reports through August 2026, 0 of them in the latest 12 months.

Which of its brands appear most often?

6 Shooter Saeed Multi-Band Ligator (579), Hemospray Endoscopic Hemostat (476), Hercules 3 Stage Wireguided Balloon Esophageal-Pyloric-Colonic (307), Instinct Endoscopic Hemoclip (291) and Instinct Plus Endoscopic Clipping Device (230).

Which device types does it report on?

unit, electrosurgical, endoscopic (with or without accessories) (24.4%), ligator, esophageal (12.1%), dilator, esophageal (11.7%) and hemostatic metal clip for the gi tract (8.9%).

Does a high count say something about the manufacturer?

Not by itself. Manufacturers must file a report for every event they become aware of, so report volume follows the number of devices in use. 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."

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. Manufacturer names are pooled after company suffixes (Inc., LLC, GmbH and similar) are dropped; names that read as a person rather than an organisation are never published. 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.