Devices › System, surgical, computer controlled instrument
Device brand name · Vision side system reconditioned
da Vinci Xi: medical device reports filed with FDA
704 reports name it, 2018–2026. Manufacturer given most often on reports: Intuitive Surgical. Product code NAY.
- 704
- device reports naming the brand
- 0% of all MAUDE reports · about 85 a year
- 265
- reports, 12 months to August 2026
- 149 in the 12 months before
- 92%
- classified as malfunction
- 90.7% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
704 medical device reports received by FDA name the brand "da Vinci Xi" (vision side system reconditioned); the manufacturer given most often on reports is Intuitive Surgical; received from April 2018 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
265 reports arrived in the 12 months to August 2026, up 78% from 149 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 (92%), injury (7.8%) and other (0.1%); 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 output problem (26.4%), visual prompts will not clear (24.9%) and energy output problem (9.2%). The patient problems coded most often are hemorrhage/blood loss/bleeding, burn(s) and internal organ perforation. 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 |
|---|---|---|---|
| Output problem | 186 | 26.4% | 3.4% |
| Visual prompts will not clear | 175 | 24.9% | 5% |
| Energy output problem | 65 | 9.2% | 1.1% |
| No display/image | 43 | 6.1% | 0.5% |
| Failure to deliver energy | 33 | 4.7% | 1.1% |
| No device output | 26 | 3.7% | 1.4% |
| Power problem | 18 | 2.6% | 0.2% |
| Display or visual feedback problem | 17 | 2.4% | 0.2% |
| Failure to power up | 16 | 2.3% | 0.2% |
| Physical resistance/sticking | 16 | 2.3% | 0.4% |
| Unintended system motionthe device moved when it should not have | 16 | 2.3% | 2% |
| Failure to sense | 9 | 1.3% | 0.3% |
| Material integrity problema problem with the device material | 9 | 1.3% | 0.4% |
| Unexpected shutdown | 7 | 1% | 0.1% |
| Grounding malfunction | 6 | 0.9% | 0.1% |
| Positioning problem | 6 | 0.9% | 0.4% |
| Unintended movement | 5 | 0.7% | 1.9% |
| Connection problema connection problem | 4 | 0.6% | 0.1% |
| Material split, cut or torn | 3 | 0.4% | 31.4% |
| Problem with software installation | 3 | 0.4% | 0% |
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 | 4 | 0.6% |
| Burn(s)a burn | 3 | 0.4% |
| Internal organ perforation | 2 | 0.3% |
| Fatiguetiredness | 1 | 0.1% |
| Fever | 1 | 0.1% |
| Kidney injury | 1 | 0.1% |
| Laceration(s) | 1 | 0.1% |
| Liver failure | 1 | 0.1% |
| Pleural effusionfluid around the lung | 1 | 0.1% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | da Vinci Xi | Product code NAY | All MAUDE reports |
|---|---|---|---|
| Reports | 704 | 141,000 | 26,136,888 |
| Share of that pool | — | 0.5% | 0% |
| Classified as death, per 1,000 reports | 0 | 6 | 9 |
| Classified as injury | 7.8% | 7.9% | 36.2% |
| Classified as malfunction | 92% | 90.7% | 62.3% |
| Filed by the manufacturer | 98.4% | 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 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% |
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 da Vinci Xi reports
How many FDA reports name da Vinci Xi?
704 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 265 in the latest 12 months.
What kinds of events are reported?
malfunction (92%), injury (7.8%) and other (0.1%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
output problem (26.4%), visual prompts will not clear (24.9%), energy output problem (9.2%), no display/image (6.1%) and failure to deliver energy (4.7%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (98.4%) and voluntary reports (1.3%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that da Vinci 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.