Device manufacturer, as written on reports
Intuitive Surgical: medical device reports filed with FDA
148,513 reports name it as the manufacturer of the device involved, 2000–2026.
- 148,513
- reports naming it as manufacturer
- 0.6% of all MAUDE reports
- 51,610
- reports, 12 months to August 2026
- 41,652 in the 12 months before
- 88.7%
- classified as malfunction
- 62.3% across all reports
- 0.6%
- classified as death, as reported
- 0.9% across all reports
148,513 medical device reports received by FDA give Intuitive Surgical as the manufacturer of the device involved, 0.6% of the MAUDE database, from February 2000 to August 2026. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.
51,610 reports arrived in the 12 months to August 2026, up 24% from 41,652 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 (88.7%), injury (9.8%) and other (0.8%). 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 |
|---|---|---|---|---|
| Endowrist | System, surgical, computer controlled instrument | 86,502 | 37,192 | 0% |
| daVinci Xi | System, surgical, computer controlled instrument | 15,714 | 5,743 | 2% |
| SureForm | Staple, implantable | 2,927 | 654 | 1.2% |
| daVinci 5 | System, surgical, computer controlled instrument | 2,394 | 2,122 | 0.7% |
| Fenestrated Bipolar Forceps Instrument | System, surgical, computer controlled instrument | 1,838 | 0 | 0% |
| EndoWrist;daVinci Si | System, surgical, computer controlled instrument | 1,759 | 356 | 0.1% |
| Ion | Bronchoscope (flexible or rigid) | 1,747 | 499 | 8.2% |
| Pk Dissecting Forceps Instrument | System, surgical, computer controlled instrument | 1,557 | 0 | 0% |
| Da Vinci Si Surgical System | System, surgical, computer controlled instrument | 1,461 | 0 | 11% |
| da Vinci | System, surgical, computer controlled instrument | 1,448 | 404 | 1.2% |
| Prograsp Forceps Instrument | System, surgical, computer controlled instrument | 1,392 | 0 | 0% |
| EndoWrist SP | System, surgical, computer controlled instrument | 1,355 | 597 | 0% |
| daVinci Si | System, surgical, computer controlled instrument | 1,222 | 129 | 2.3% |
| Monopolar Curved Scissors Instrument | System, surgical, computer controlled instrument | 1,056 | 0 | 0% |
| Maryland Bipolar Forceps Instrument | System, surgical, computer controlled instrument | 952 | 0 | 0% |
| daVinci X | System, surgical, computer controlled instrument | 938 | 420 | 5.4% |
| Da Vinci S Surgical System | System, surgical, computer controlled instrument | 805 | 0 | 7.6% |
| Mega Suturecut Needle Driver Instrument | System, surgical, computer controlled instrument | 777 | 0 | 0% |
| da Vinci Energy | System, surgical, computer controlled instrument | 760 | 230 | 0.7% |
| Da Vinci Surgical System | System, surgical, computer controlled instrument | 745 | 19 | 5% |
| da Vinci SP | System, surgical, computer controlled instrument | 736 | 396 | 1.4% |
| da Vinci Xi | System, surgical, computer controlled instrument | 704 | 265 | 0% |
| Permanent Cautery Hook Instrument | System, surgical, computer controlled instrument | 482 | 0 | 0% |
| Large Needle Driver Instrument | System, surgical, computer controlled instrument | 433 | 0 | 0% |
| Mega Needle Driver Instrument | System, surgical, computer controlled instrument | 393 | 0 | 0% |
| Single-Site | System, surgical, computer controlled instrument | 353 | 68 | 0% |
| Tenaculum Forceps Instrument | System, surgical, computer controlled instrument | 350 | 0 | 0% |
| Fenestrated Bipolar Forceps | System, surgical, computer controlled instrument | 304 | 2 | 0% |
| Large Suturecut Needle Driverinstrument | System, surgical, computer controlled instrument | 303 | 0 | 0% |
| 8mm Mcs Tip Cover Accessory | System, surgical, computer controlled instrument | 295 | 0 | 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 |
|---|---|---|---|
| NAY | System, surgical, computer controlled instrument | 140,680 | 94.7% |
| GDW | Staple, implantable | 2,481 | 1.7% |
| GCJ | Laparoscope, general & plastic surgery | 2,194 | 1.5% |
| EOQ | Bronchoscope (flexible or rigid) | 1,797 | 1.2% |
| GEI | Electrosurgical, cutting & coagulation & accessories | 1,180 | 0.8% |
| LFL | Instrument, ultrasonic surgical | 31 | 0% |
| IZI | System, x-ray, angiographic | 23 | 0% |
| GAG | Stapler, surgical | 15 | 0% |
| GDC | Table, operating-room, electrical | 15 | 0% |
| GDO | Applier, surgical, clip | 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
Grey bar: all 26,136,888 MAUDE reports. Event type is the filer's classification and is not verified by FDA.
Questions about Intuitive Surgical reports
How many FDA device reports name Intuitive Surgical as manufacturer?
148,513 reports through August 2026, 51,610 of them in the latest 12 months.
Which of its brands appear most often?
Endowrist (86,502), daVinci Xi (15,714), SureForm (2,927), daVinci 5 (2,394) and Fenestrated Bipolar Forceps Instrument (1,838).
Which device types does it report on?
system, surgical, computer controlled instrument (94.7%), staple, implantable (1.7%), laparoscope, general & plastic surgery (1.5%) and bronchoscope (flexible or rigid) (1.2%).
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.