Device manufacturer, as written on reports

Covidien North Haven: medical device reports filed with FDA

47,664 reports name it as the manufacturer of the device involved, 2017–2026.

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.

47,664
reports naming it as manufacturer: 0.2% of all MAUDE reports; 5
reports, 12 months to August 2026: 4,442 in the 12 months before; 84.8%
classified as malfunction: 62.3% across all reports; 0.4%
classified as death, as reported: 0.9% across all reports

47,664 medical device reports received by FDA give Covidien North Haven as the manufacturer of the device involved, 0.2% of the MAUDE database, from February 2017 to June 2026. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

5 reports arrived in the 12 months to August 2026, down 100% from 4,442 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 (84.8%), injury (14.8%) 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
Endo GIA	Staple, implantable	18,590	2,086	0.3%
Signia	Staple, implantable	7,869	1,130	0.1%
Tri-Staple 2.0	Staple, implantable	4,384	661	0.3%
V-Loc 180	Suture, absorbable, synthetic, polyglycolic acid	2,443	678	0%
Unknown Endo GIA SULU	Staple, implantable	1,979	205	1.9%
Polysorb	Suture, absorbable, synthetic, polyglycolic acid	1,696	1,836	0%
V-Loc 90	Suture, absorbable, synthetic, polyglycolic acid	1,044	226	0%
Lapro-Clip	Laparoscope, general & plastic surgery	755	54	0.2%
Surgipro	Mesh, surgical, polymeric	749	89	0.9%
AbsorbaTack	Staple, implantable	736	165	0%
Gia	Staple, implantable	629	404	0.9%
Idrive Ultra	Staple, implantable	574	0	0.1%
Unknown Signia EGIA Adapter	Staple, implantable	515	63	0.2%
EEA OrVil	Staple, implantable	428	33	2%
ReliaTack	Staple, implantable	385	24	0%
Eea	Staple, implantable	374	542	0.8%
Endo GIA Ultra	Staple, implantable	300	1,116	0.1%
Unknown Egia Tri Staple	Staple, implantable	284	28	2.8%
Unknown Stapling Device	Staple, implantable	274	8	1.2%
V-Loc	Suture, nonabsorbable, synthetic, polyethylene	241	72	0%
Unknown VLoc Product	Suture, absorbable, synthetic, polyglycolic acid	236	39	3.6%
Unknown Egia Adapter	Staple, implantable	183	0	0%
Endo Clip	Clip, implantable	178	85	0.1%
Idrive	Staple, implantable	175	0	0%
Unknown Egia Sulu	Staple, implantable	172	0	4.5%
Unknown Endo GIA Instrument	Staple, implantable	149	33	0.5%
Unknown Suture Product	Suture, absorbable, synthetic, polyglycolic acid	66	28	0.9%
Endo Stitch	Endoscopic tissue approximation device	29	64	0.1%
Unknown Endo Gia	Staple, implantable	27	0	0.8%
Surgipro ll	Suture, nonabsorbable, synthetic, polypropylene	18	37	0.5%

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	39,073	82%
GAM	Suture, absorbable, synthetic, polyglycolic acid	5,674	11.9%
GCJ	Laparoscope, general & plastic surgery	903	1.9%
FTL	Mesh, surgical, polymeric	854	1.8%
GAT	Suture, nonabsorbable, synthetic, polyethylene	315	0.7%
GAG	Stapler, surgical	221	0.5%
FZP	Clip, implantable	205	0.4%
GAW	Suture, nonabsorbable, synthetic, polypropylene	89	0.2%
LMG	Agent, absorbable hemostatic, non-collagen based	51	0.1%
LFL	Instrument, ultrasonic surgical	32	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%188

Injury14.8%7,068

Malfunction84.8%40,408

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 North Haven reports

How many FDA device reports name Covidien North Haven as manufacturer?

47,664 reports through August 2026, 5 of them in the latest 12 months.

Which of its brands appear most often?

Endo GIA (18,590), Signia (7,869), Tri-Staple 2.0 (4,384), V-Loc 180 (2,443) and Unknown Endo GIA SULU (1,979).

Which device types does it report on?

staple, implantable (82%), suture, absorbable, synthetic, polyglycolic acid (11.9%), laparoscope, general & plastic surgery (1.9%) and mesh, surgical, polymeric (1.8%).

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.