Device manufacturer, as written on reports

United States Surgical: medical device reports filed with FDA

22,288 reports name it as the manufacturer of the device involved, 1992–2012.

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.

22,288
reports naming it as manufacturer: 0.1% of all MAUDE reports; 0
reports, 12 months to August 2026: 0 in the 12 months before; 81.8%
classified as malfunction: 62.3% across all reports; 0.4%
classified as death, as reported: 0.9% across all reports

22,288 medical device reports received by FDA give United States Surgical as the manufacturer of the device involved, 0.1% of the MAUDE database, from February 1992 to May 2012. 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 (81.8%), injury (17%) 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
Auto Suture Multifire Endo Gia 30-2 5	Laparoscope, general & plastic surgery	902	0	0%
Auto Suture Endo Clip 5mm	Laparoscope, general & plastic surgery	794	0	0%
Auto Suture Multifire Endo Gia 30-3 5	Laparoscope, general & plastic surgery	733	0	0%
Auto Suture Roticulator 55-4 8	Stapler, surgical	433	0	0.2%
Auto Suture Roticulator 55 Poly - 200	Stapler, surgical	350	0	0%
Auto Suture Premium Plus Ceea 31mm	Stapler, surgical	311	0	0.3%
Auto Suture Versaport 5mm-11mm	Laparoscope, general & plastic surgery	306	0	0.3%
Auto Suture Versaport 5mm-12mm	Laparoscope, general & plastic surgery	271	0	0%
Auto Suture Roticulator 55-3 5	Stapler, surgical	265	0	0.6%
Auto Suture Endo Stitch	Laparoscope, general & plastic surgery	240	0	0%
Auto Suture Endo Clip L	Laparoscope, general & plastic surgery	226	0	0%
Endo Gia Universal 12mm Single Use Inst	Staple, implantable	223	0	1.8%
Auto Suture Multifire Gia 60-3 8	Stapler, surgical	212	0	0.9%
Auto Suture Endo Universal 65-4 8	Laparoscope, general & plastic surgery	197	0	0%
Auto Suture Premium Plus Ceea 28mm	Stapler, surgical	180	0	0%
Auto Suture Powered Multifire Endo Gia 60-4 8	Laparoscope, general & plastic surgery	176	0	0%
Auto Suture Roticulator 55 Poly 200	Stapler, surgical	176	0	0%
Auto Suture Multifire Gia 80-3 8	Stapler, surgical	165	0	0.5%
Auto Suture Premium Surgiclip M-11 5	Stapler, surgical	147	0	0%
Autosonix Ultra Shears 5mm Instrument	Instrument, ultrasonic surgical	147	0	0%
Auto Suture Powered Multifire Endo Gia 60-3 5	Laparoscope, general & plastic surgery	118	0	0%
Endo Stitch 10mm Suturing Device	—	84	0	0%
Endo Gia Roticulator 60-3 5 Sulu	Staple, implantable	74	0	1.4%
Egia Ultra Universal Stapler	Staple, implantable	70	0	2.8%
Autosuture	Stapler, surgical	69	0	1.2%
Auto Suture	Laparoscope, general & plastic surgery	64	234	0.1%
Gia Universal	Staple, implantable	62	0	1.5%
Endo Gia Roticulator 45-3 5 Sulu	Staple, implantable	46	0	0%
Dst Series Eea Orvil 25mm Device	Staple, implantable	45	0	0.5%
Egia 60 Articulating Med/Thick Sulu	Staple, implantable	36	0	1.2%

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
GCJ	Laparoscope, general & plastic surgery	10,352	46.4%
GAG	Stapler, surgical	6,759	30.3%
GDW	Staple, implantable	1,216	5.5%
GAN	Suture, absorbable, synthetic	663	3%
GAM	Suture, absorbable, synthetic, polyglycolic acid	594	2.7%
GDO	Applier, surgical, clip	448	2%
LFL	Instrument, ultrasonic surgical	398	1.8%
GAW	Suture, nonabsorbable, synthetic, polypropylene	379	1.7%
GAL	Suture, absorbable, natural	115	0.5%
GAP	Suture, nonabsorbable, silk	94	0.4%

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%92

Injury17%3,788

Malfunction81.8%18,234

Other0.3%75

Not given0.4%99

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

Questions about United States Surgical reports

How many FDA device reports name United States Surgical as manufacturer?

22,288 reports through August 2026, 0 of them in the latest 12 months.

Which of its brands appear most often?

Auto Suture Multifire Endo Gia 30-2 5 (902), Auto Suture Endo Clip 5mm (794), Auto Suture Multifire Endo Gia 30-3 5 (733), Auto Suture Roticulator 55-4 8 (433) and Auto Suture Roticulator 55 Poly - 200 (350).

Which device types does it report on?

laparoscope, general & plastic surgery (46.4%), stapler, surgical (30.3%), staple, implantable (5.5%) and suture, absorbable, synthetic (3%).

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.