Device manufacturer, as written on reports

Covidien Mfg Dc Boulder: medical device reports filed with FDA

14,148 reports name it as the manufacturer of the device involved, 2017–2025.

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.

14,148
reports naming it as manufacturer: 0.1% of all MAUDE reports; 0
reports, 12 months to August 2026: 1,254 in the 12 months before; 88.5%
classified as malfunction: 62.3% across all reports; 0.6%
classified as death, as reported: 0.9% across all reports

14,148 medical device reports received by FDA give Covidien Mfg Dc Boulder as the manufacturer of the device involved, 0.1% of the MAUDE database, from February 2017 to July 2025. 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, against 1,254 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 (88.5%), injury (10.9%) and death (0.6%). 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
LigaSure	Electrosurgical, cutting & coagulation & accessories	6,352	879	0.2%
Sonicision	Instrument, ultrasonic surgical	1,551	139	0.2%
Valleylab Ft10	Electrosurgical, cutting & coagulation & accessories	1,169	2	0.3%
Valleylab	Electrosurgical, cutting & coagulation & accessories	1,050	353	0.3%
Edge	Electrosurgical, cutting & coagulation & accessories	540	171	0.1%
Cool-tip	Electrosurgical, cutting & coagulation & accessories	397	28	2%
Force Fx	Electrosurgical, cutting & coagulation & accessories	383	22	0.4%
ForceTriad	Electrosurgical, cutting & coagulation & accessories	365	13	0.2%
LigaSure Impact	Electrosurgical, cutting & coagulation & accessories	317	72	0.3%
Unknown Ligasure Instrument	Electrosurgical, cutting & coagulation & accessories	280	35	8.1%
LigaSure XP	Electrosurgical, cutting & coagulation & accessories	235	177	0%
Situate	Gauze/sponge, internal, x-ray detectable	186	50	0%
Ligasure Advance	Electrosurgical, cutting & coagulation & accessories	147	0	0%
BiZact	Electrosurgical, cutting & coagulation & accessories	141	19	0.6%
LigaSure Atlas	Electrosurgical, cutting & coagulation & accessories	23	16	0.7%
Emprint	Electrosurgical, cutting & coagulation & accessories	14	39	2.6%
Invos	Oximeter, tissue saturation	4	50	1.1%
Ligasure Precise	Electrosurgical, cutting & coagulation & accessories	3	0	0.4%
TruClear	Hysteroscope (and accessories)	3	58	0.6%
Spacemaker	Laparoscope, general & plastic surgery	2	146	0%
Barrx	Electrosurgical, cutting & coagulation & accessories	1	19	1.1%
Covidien	Mesh, surgical, polymeric	1	30	1.4%
Endo GIA	Staple, implantable	1	2,086	0.3%

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
GEI	Electrosurgical, cutting & coagulation & accessories	12,218	86.4%
LFL	Instrument, ultrasonic surgical	1,558	11%
LWH	Counter, sponge, surgical	156	1.1%
NEY	System, ablation, microwave and accessories	60	0.4%
GDY	Gauze/sponge, internal, x-ray detectable	38	0.3%
DRG	Transmitters and receivers, physiological signal, radiofrequency	19	0.1%
HGI	Electrocautery, gynecologic (and accessories)	19	0.1%
FYD	Apparatus, exhaust, surgical	17	0.1%
GCJ	Laparoscope, general & plastic surgery	9	0.1%
HIH	Hysteroscope (and accessories)	7	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

Death0.6%82

Injury10.9%1,549

Malfunction88.5%12,517

Other0%0

Not given0%0

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

Questions about Covidien Mfg Dc Boulder reports

How many FDA device reports name Covidien Mfg Dc Boulder as manufacturer?

14,148 reports through August 2026, 0 of them in the latest 12 months.

Which of its brands appear most often?

LigaSure (6,352), Sonicision (1,551), Valleylab Ft10 (1,169), Valleylab (1,050) and Edge (540).

Which device types does it report on?

electrosurgical, cutting & coagulation & accessories (86.4%), instrument, ultrasonic surgical (11%), counter, sponge, surgical (1.1%) and system, ablation, microwave and accessories (0.4%).

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.