Devices › System, surgical, computer controlled instrument
Device brand name · Patient side cart 4-arm
daVinci Si: medical device reports filed with FDA
1,225 reports name it, 2018–2026. Manufacturer given most often on reports: Intuitive Surgical. Product code NAY.
- 1,225
- device reports naming the brand
- 0% of all MAUDE reports · about 146 a year
- 129
- reports, 12 months to August 2026
- 117 in the 12 months before
- 80.8%
- classified as malfunction
- 90.7% across the product code
- 2.3%
- classified as death, as reported
- 28 reports · not verified by FDA
1,225 medical device reports received by FDA name the brand "daVinci Si" (patient side cart 4-arm); the manufacturer given most often on reports is Intuitive Surgical; received from February 2018 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
129 reports arrived in the 12 months to August 2026, up 10% from 117 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 (80.8%), injury (16.9%) and death (2.3%); across all system, surgical, computer controlled instrument reports (product code NAY) death is recorded in 0.6% and malfunction in 90.7%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are visual prompts will not clear (24.7%), device displays incorrect message (12.5%) and defective component (8.2%). The patient problems coded most often are hemorrhage/blood loss/bleeding, injury and hematoma. 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."
Reports by month, five years
Reports by the month FDA received them. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 141,000 reports carrying product code NAY. Event type is the filer's classification and is not verified by FDA.
Device problems coded
| Device problem (FDA code) | Reports | Share | Share across product code |
|---|---|---|---|
| Visual prompts will not clear | 302 | 24.7% | 5% |
| Device displays incorrect message | 153 | 12.5% | 1% |
| Defective component | 101 | 8.2% | 0.3% |
| No device output | 80 | 6.5% | 1.4% |
| No display/image | 71 | 5.8% | 0.5% |
| Output problem | 71 | 5.8% | 3.4% |
| Unintended system motionthe device moved when it should not have | 52 | 4.2% | 2% |
| Optical problem | 38 | 3.1% | 0.1% |
| Insufficient device problem information | 37 | 3% | 1.1% |
| Poor quality image | 34 | 2.8% | 0.1% |
| Device operates differently than expectedthe device behaved unexpectedly | 30 | 2.4% | 1.4% |
| Physical resistance/sticking | 30 | 2.4% | 0.4% |
| Positioning failure | 25 | 2% | 0.1% |
| Electrical /electronic property probleman electrical or electronic problem | 21 | 1.7% | 0.1% |
| Difficult to open or close | 17 | 1.4% | 4.5% |
| Failure to power up | 15 | 1.2% | 0.2% |
| Misfocusing | 14 | 1.1% | 0% |
| Display or visual feedback problem | 13 | 1.1% | 0.2% |
| Material integrity problema problem with the device material | 12 | 1% | 0.4% |
| Defective devicethe device was defective | 10 | 0.8% | 0.3% |
FDA's device problem codes as entered on the report; one report can carry several. Generic codes such as "no apparent adverse event" are left out.
Patient problems coded
| Patient problem (FDA code) | Reports | Share |
|---|---|---|
| Hemorrhage/blood loss/bleeding | 36 | 2.9% |
| Injurya physical injury | 18 | 1.5% |
| Hematomaa collection of blood under the skin or in tissue | 10 | 0.8% |
| Blood loss | 9 | 0.7% |
| Deaththe patient died; cause not stated by this term | 9 | 0.7% |
| Bowel perforation | 8 | 0.7% |
| Failure to anastomose | 8 | 0.7% |
| Abscessa collection of pus | 6 | 0.5% |
| Painpain, site not specified | 6 | 0.5% |
| Sepsisa severe body-wide response to infection | 6 | 0.5% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 5 | 0.4% |
| Bowel burn | 5 | 0.4% |
| Burn(s)a burn | 4 | 0.3% |
| Laceration(s) | 4 | 0.3% |
| Abdominal painstomach or belly pain | 3 | 0.2% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | daVinci Si | Product code NAY | All MAUDE reports |
|---|---|---|---|
| Reports | 1,225 | 141,000 | 26,136,888 |
| Share of that pool | — | 0.9% | 0% |
| Classified as death, per 1,000 reports | 23 | 6 | 9 |
| Classified as injury | 16.9% | 7.9% | 36.2% |
| Classified as malfunction | 80.8% | 90.7% | 62.3% |
| Filed by the manufacturer | 99.7% | 97.1% | 94.9% |
Shares are of reports, not 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."
Other brands with product code NAY
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Endowrist | 86,566 | 37,192 | 0% |
| daVinci Xi | 15,722 | 5,743 | 2% |
| daVinci 5 | 2,394 | 2,122 | 0.7% |
| Fenestrated Bipolar Forceps Instrument | 1,839 | 0 | 0% |
| EndoWrist;daVinci Si | 1,771 | 356 | 0.1% |
| Pk Dissecting Forceps Instrument | 1,564 | 0 | 0% |
| Da Vinci Si Surgical System | 1,461 | 0 | 11% |
| Prograsp Forceps Instrument | 1,396 | 0 | 0% |
| EndoWrist SP | 1,355 | 597 | 0% |
| da Vinci | 1,483 | 404 | 1.2% |
| daVinci X | 938 | 420 | 5.4% |
| Maryland Bipolar Forceps Instrument | 952 | 0 | 0% |
| SureForm | 2,927 | 654 | 1.2% |
| Monopolar Curved Scissors Instrument | 1,056 | 0 | 0% |
| Da Vinci S Surgical System | 815 | 0 | 7.6% |
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." FDA also states that "common products may have a higher number of adverse events due to the higher total number of people using the product."
Questions about daVinci Si reports
How many FDA reports name daVinci Si?
1,225 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 129 in the latest 12 months.
What kinds of events are reported?
malfunction (80.8%), injury (16.9%) and death (2.3%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
visual prompts will not clear (24.7%), device displays incorrect message (12.5%), defective component (8.2%), no device output (6.5%) and no display/image (5.8%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.7%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that daVinci Si was at fault?
No. 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." FDA adds that "a causal relationship cannot be established between product and reactions listed in a report."
How do I report a problem with a medical device?
Through FDA MedWatch (Form FDA 3500 for health professionals and consumers), or to the manufacturer. See the guide on how to report.
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. A report counts here when any device it lists carries this brand name after punctuation and capitalisation are normalised. 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.