Devices › System, surgical, computer controlled instrument
Device brand name · Harmonic ace
da Vinci: medical device reports filed with FDA
1,483 reports name it, 2005–2026. Manufacturer given most often on reports: Intuitive Surgical. Product code NAY.
- 1,483
- device reports naming the brand
- 0% of all MAUDE reports · about 70 a year
- 404
- reports, 12 months to August 2026
- 324 in the 12 months before
- 27.2%
- classified as malfunction
- 90.7% across the product code
- 1.2%
- classified as death, as reported
- 18 reports · not verified by FDA
1,483 medical device reports received by FDA name the brand "da Vinci" (harmonic ace); the manufacturer given most often on reports is Intuitive Surgical; received from March 2005 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
404 reports arrived in the 12 months to August 2026, up 25% from 324 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 injury (70.9%), malfunction (27.2%) and death (1.2%); 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 detachment of device or device component (30.3%), material fragmentation (14.8%) and material separation (10%). The patient problems coded most often are foreign body in patient, hemorrhage/blood loss/bleeding and device embedded in tissue or plaque. 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 |
|---|---|---|---|
| Detachment of device or device componentpart of the device came off | 449 | 30.3% | 5% |
| Material fragmentation | 219 | 14.8% | 5.7% |
| Material separation | 149 | 10% | 0.6% |
| Breakthe device broke | 75 | 5.1% | 10.3% |
| Image orientation incorrect | 71 | 4.8% | 0.4% |
| Insufficient device problem information | 60 | 4% | 1.1% |
| Material split, cut or torn | 55 | 3.7% | 31.4% |
| Arcing | 43 | 2.9% | 1.2% |
| Unintended system motionthe device moved when it should not have | 27 | 1.8% | 2% |
| Thermal decomposition of device | 19 | 1.3% | 1.9% |
| Loss of or failure to bond | 17 | 1.1% | 0% |
| Output problem | 15 | 1% | 3.4% |
| Device dislodged or dislocated | 12 | 0.8% | 0.4% |
| Crackthe device cracked | 10 | 0.7% | 0.2% |
| Visual prompts will not clear | 10 | 0.7% | 5% |
| No device output | 9 | 0.6% | 1.4% |
| Difficult to open or close | 7 | 0.5% | 4.5% |
| Display or visual feedback problem | 6 | 0.4% | 0.2% |
| Energy output problem | 6 | 0.4% | 1.1% |
| Gas/air leak | 6 | 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 |
|---|---|---|
| Foreign body in patientpart of a device left in the patient | 224 | 15.1% |
| Hemorrhage/blood loss/bleeding | 67 | 4.5% |
| Device embedded in tissue or plaque | 50 | 3.4% |
| Burn(s)a burn | 28 | 1.9% |
| Injurya physical injury | 15 | 1% |
| Fistula | 11 | 0.7% |
| Blood loss | 10 | 0.7% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 9 | 0.6% |
| Hematomaa collection of blood under the skin or in tissue | 8 | 0.5% |
| Sepsisa severe body-wide response to infection | 8 | 0.5% |
| Bowel burn | 7 | 0.5% |
| Bowel perforation | 7 | 0.5% |
| Obstruction/occlusion | 6 | 0.4% |
| Painpain, site not specified | 6 | 0.4% |
| Failure to anastomose | 5 | 0.3% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | da Vinci | Product code NAY | All MAUDE reports |
|---|---|---|---|
| Reports | 1,483 | 141,000 | 26,136,888 |
| Share of that pool | — | 1.1% | 0% |
| Classified as death, per 1,000 reports | 12 | 6 | 9 |
| Classified as injury | 70.9% | 7.9% | 36.2% |
| Classified as malfunction | 27.2% | 90.7% | 62.3% |
| Filed by the manufacturer | 94.1% | 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% |
| 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 da Vinci reports
How many FDA reports name da Vinci?
1,483 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 404 in the latest 12 months.
What kinds of events are reported?
injury (70.9%), malfunction (27.2%) and death (1.2%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
detachment of device or device component (30.3%), material fragmentation (14.8%), material separation (10%), break (5.1%) and image orientation incorrect (4.8%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (94.1%) and voluntary reports (2.4%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that da Vinci 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.