Devices › System, surgical, computer controlled instrument
Device brand name · Monopolar curved scissors
EndoWrist;daVinci Si: medical device reports filed with FDA
1,771 reports name it, 2017–2026. Manufacturer given most often on reports: Intuitive Surgical. Product code NAY.
- 1,771
- device reports naming the brand
- 0% of all MAUDE reports · about 187 a year
- 356
- reports, 12 months to August 2026
- 299 in the 12 months before
- 93.6%
- classified as malfunction
- 90.7% across the product code
- 0.1%
- classified as death, as reported
- 1 reports · not verified by FDA
1,771 medical device reports received by FDA name the brand "EndoWrist;daVinci Si" (monopolar curved scissors); the manufacturer given most often on reports is Intuitive Surgical; received from January 2017 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
356 reports arrived in the 12 months to August 2026, up 19% from 299 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 (93.6%), injury (6.4%) and death (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 material split, cut or torn (31.3%), break (17.6%) and detachment of device or device component (11.3%). The patient problems coded most often are device embedded in tissue or plaque, foreign body in patient and hemorrhage/blood loss/bleeding. 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 |
|---|---|---|---|
| Material split, cut or torn | 555 | 31.3% | 31.4% |
| Breakthe device broke | 311 | 17.6% | 10.3% |
| Detachment of device or device componentpart of the device came off | 200 | 11.3% | 5% |
| Thermal decomposition of device | 132 | 7.5% | 1.9% |
| Arcing | 118 | 6.7% | 1.2% |
| Material fragmentation | 102 | 5.8% | 5.7% |
| Difficult to open or close | 81 | 4.6% | 4.5% |
| Failure to deliver energy | 68 | 3.8% | 1.1% |
| Unintended system motionthe device moved when it should not have | 49 | 2.8% | 2% |
| Unintended movement | 31 | 1.8% | 1.9% |
| No device output | 29 | 1.6% | 1.4% |
| Device dislodged or dislocated | 21 | 1.2% | 0.4% |
| Material integrity problema problem with the device material | 21 | 1.2% | 0.4% |
| Material frayed | 20 | 1.1% | 7.7% |
| Detachment of device component | 17 | 1% | 0.9% |
| Energy output problem | 13 | 0.7% | 1.1% |
| Insufficient device problem information | 12 | 0.7% | 1.1% |
| Defective devicethe device was defective | 11 | 0.6% | 0.3% |
| Melted | 10 | 0.6% | 0.1% |
| Retraction problem | 10 | 0.6% | 0.1% |
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 |
|---|---|---|
| Device embedded in tissue or plaque | 35 | 2% |
| Foreign body in patientpart of a device left in the patient | 23 | 1.3% |
| Hemorrhage/blood loss/bleeding | 17 | 1% |
| Blood loss | 16 | 0.9% |
| Burn(s)a burn | 8 | 0.5% |
| Burn, thermal | 8 | 0.5% |
| Injurya physical injury | 6 | 0.3% |
| Bowel burn | 3 | 0.2% |
| Tissue damage | 3 | 0.2% |
| Bowel perforation | 2 | 0.1% |
| No patient involvement | 2 | 0.1% |
| Abscessa collection of pus | 1 | 0.1% |
| Biliary leak | 1 | 0.1% |
| Deaththe patient died; cause not stated by this term | 1 | 0.1% |
| Dysuriapain on passing urine | 1 | 0.1% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | EndoWrist;daVinci Si | Product code NAY | All MAUDE reports |
|---|---|---|---|
| Reports | 1,771 | 141,000 | 26,136,888 |
| Share of that pool | — | 1.3% | 0% |
| Classified as death, per 1,000 reports | 1 | 6 | 9 |
| Classified as injury | 6.4% | 7.9% | 36.2% |
| Classified as malfunction | 93.6% | 90.7% | 62.3% |
| Filed by the manufacturer | 95.6% | 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% |
| 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 EndoWrist;daVinci Si reports
How many FDA reports name EndoWrist;daVinci Si?
1,771 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 356 in the latest 12 months.
What kinds of events are reported?
malfunction (93.6%), injury (6.4%) and death (0.1%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
material split, cut or torn (31.3%), break (17.6%), detachment of device or device component (11.3%), thermal decomposition of device (7.5%) and arcing (6.7%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (95.6%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that EndoWrist;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.