Devices › System, surgical, computer controlled instrument
Device brand name · Patient side cart 4-arm
daVinci Xi: medical device reports filed with FDA
15,722 reports name it, 2018–2026. Manufacturer given most often on reports: Intuitive Surgical. Product code NAY.
- 15,722
- device reports naming the brand
- 0.1% of all MAUDE reports · about 1,887 a year
- 5,743
- reports, 12 months to August 2026
- 3,260 in the 12 months before
- 85.4%
- classified as malfunction
- 90.7% across the product code
- 2%
- classified as death, as reported
- 308 reports · not verified by FDA
FDA's MAUDE database holds 15,722 reports that name the brand "daVinci Xi" (patient side cart 4-arm), received between March 2018 and August 2026; the manufacturer given most often on reports is Intuitive Surgical. Spellings of one product vary from report to report.
5,743 reports arrived in the 12 months to August 2026, up 76% from 3,260 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 (85.4%), injury (12.6%) and death (2%); 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 (30.4%), output problem (23.1%) and unintended system motion (5%). The patient problems coded most often are hemorrhage/blood loss/bleeding, burn(s) and cardiac arrest. 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 | 4,782 | 30.4% | 5% |
| Output problem | 3,627 | 23.1% | 3.4% |
| Unintended system motionthe device moved when it should not have | 784 | 5% | 2% |
| Energy output problem | 781 | 5% | 1.1% |
| No device output | 755 | 4.8% | 1.4% |
| No display/image | 475 | 3% | 0.5% |
| Failure to deliver energy | 344 | 2.2% | 1.1% |
| Unintended movement | 322 | 2% | 1.9% |
| Physical resistance/sticking | 309 | 2% | 0.4% |
| Insufficient device problem information | 274 | 1.7% | 1.1% |
| Positioning problem | 250 | 1.6% | 0.4% |
| Power problem | 218 | 1.4% | 0.2% |
| Failure to sense | 188 | 1.2% | 0.3% |
| Grounding malfunction | 182 | 1.2% | 0.1% |
| Device displays incorrect message | 165 | 1% | 1% |
| Defective component | 130 | 0.8% | 0.3% |
| Display or visual feedback problem | 114 | 0.7% | 0.2% |
| Positioning failure | 90 | 0.6% | 0.1% |
| Failure to power up | 87 | 0.6% | 0.2% |
| Material integrity problema problem with the device material | 81 | 0.5% | 0.4% |
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 | 543 | 3.5% |
| Burn(s)a burn | 85 | 0.5% |
| Cardiac arrestthe heart stopped | 59 | 0.4% |
| Bowel perforation | 55 | 0.3% |
| Hematomaa collection of blood under the skin or in tissue | 50 | 0.3% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 43 | 0.3% |
| Sepsisa severe body-wide response to infection | 42 | 0.3% |
| Blood loss | 41 | 0.3% |
| Fistula | 40 | 0.3% |
| Perforation of vessels | 40 | 0.3% |
| Bacterial infectiona bacterial infection | 38 | 0.2% |
| Great vessel perforation | 37 | 0.2% |
| Painpain, site not specified | 35 | 0.2% |
| Pneumothoraxa collapsed lung | 31 | 0.2% |
| Deaththe patient died; cause not stated by this term | 29 | 0.2% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | daVinci Xi | Product code NAY | All MAUDE reports |
|---|---|---|---|
| Reports | 15,722 | 141,000 | 26,136,888 |
| Share of that pool | — | 11.2% | 0.1% |
| Classified as death, per 1,000 reports | 20 | 6 | 9 |
| Classified as injury | 12.6% | 7.9% | 36.2% |
| Classified as malfunction | 85.4% | 90.7% | 62.3% |
| Filed by the manufacturer | 99.9% | 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 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 Si | 1,225 | 129 | 2.3% |
| 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 Xi reports
How many FDA reports name daVinci Xi?
15,722 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 5,743 in the latest 12 months.
What kinds of events are reported?
malfunction (85.4%), injury (12.6%) and death (2%). "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 (30.4%), output problem (23.1%), unintended system motion (5%), energy output problem (5%) and no device output (4.8%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.9%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that daVinci Xi 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.