Device manufacturer, as written on reports

Covidien Surgical: medical device reports filed with FDA

7,203 reports name it as the manufacturer of the device involved, 2023–2026.

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.

7,203
reports naming it as manufacturer: 0% of all MAUDE reports; 6,082
reports, 12 months to August 2026: 1,114 in the 12 months before; 91.3%
classified as malfunction: 62.3% across all reports; 0.4%
classified as death, as reported: 0.9% across all reports

7,203 medical device reports received by FDA give Covidien Surgical as the manufacturer of the device involved, 0% of the MAUDE database, from March 2023 to August 2026. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

6,082 reports arrived in the 12 months to August 2026, up 446% from 1,114 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 (91.3%), injury (8.3%) and death (0.4%). 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
Polysorb	Suture, absorbable, synthetic, polyglycolic acid	1,459	1,836	0%
Signia	Staple, implantable	1,327	1,130	0.1%
Endo GIA	Staple, implantable	1,110	2,086	0.3%
V-Loc 180	Suture, absorbable, synthetic, polyglycolic acid	816	678	0%
Tri-Staple 2.0	Staple, implantable	768	661	0.3%
V-Loc 90	Suture, absorbable, synthetic, polyglycolic acid	286	226	0%
Gia	Staple, implantable	242	404	0.9%
Unknown Endo GIA SULU	Staple, implantable	240	205	1.9%
AbsorbaTack	Staple, implantable	206	165	0%
V-Loc	Suture, nonabsorbable, synthetic, polyethylene	76	72	0%
Unknown Signia EGIA Adapter	Staple, implantable	72	63	0.2%
Lapro-Clip	Laparoscope, general & plastic surgery	62	54	0.2%
Hugo RAS System	Modular electromechanical surgical system	54	1,428	0%
Unknown VLoc Product	Suture, absorbable, synthetic, polyglycolic acid	42	39	3.6%
EEA OrVil	Staple, implantable	38	33	2%
Surgipro	Mesh, surgical, polymeric	37	89	0.9%
ReliaTack	Staple, implantable	31	24	0%
Unknown Egia Tri Staple	Staple, implantable	31	28	2.8%
Unknown Suture Product	Suture, absorbable, synthetic, polyglycolic acid	30	28	0.9%
Eea	Staple, implantable	29	542	0.8%
Monosof	Suture, nonabsorbable, synthetic, polyamide	16	89	0%
Unknown Stapling Device	Staple, implantable	9	8	1.2%
VersaOne	Laparoscope, general & plastic surgery	9	251	0.2%
Unknown Endo GIA Instrument	Staple, implantable	4	33	0.5%
Endo GIA Ultra	Staple, implantable	3	1,116	0.1%
Ta	Staple, implantable	3	142	1%
Maxon	Suture, absorbable, synthetic, polyglycolic acid	2	309	0%

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
GDW	Staple, implantable	4,044	56.1%
GAM	Suture, absorbable, synthetic, polyglycolic acid	2,654	36.8%
GAG	Stapler, surgical	207	2.9%
GCJ	Laparoscope, general & plastic surgery	78	1.1%
GAT	Suture, nonabsorbable, synthetic, polyethylene	77	1.1%
SCV	Modular electromechanical surgical system	62	0.9%
FTL	Mesh, surgical, polymeric	38	0.5%
GAR	Suture, nonabsorbable, synthetic, polyamide	17	0.2%
GAW	Suture, nonabsorbable, synthetic, polypropylene	10	0.1%
OCW	Endoscopic tissue approximation device	5	0.1%

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

Death0.4%30

Injury8.3%599

Malfunction91.3%6,574

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 Surgical reports

How many FDA device reports name Covidien Surgical as manufacturer?

7,203 reports through August 2026, 6,082 of them in the latest 12 months.

Which of its brands appear most often?

Polysorb (1,459), Signia (1,327), Endo GIA (1,110), V-Loc 180 (816) and Tri-Staple 2.0 (768).

Which device types does it report on?

staple, implantable (56.1%), suture, absorbable, synthetic, polyglycolic acid (36.8%), stapler, surgical (2.9%) and laparoscope, general & plastic surgery (1.1%).

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.