EndoWrist;daVinci Si 420179Recalls & reported problems
Intuitive Surgical, Inc. · MONOPOLAR CURVED SCISSORS · Class 2
All models of EndoWrist;daVinci Si (35)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Intuitive EndoWrist monopolar curved scissors, a robotic surgery instrument, has 336 reports, 20 of them injuries and no deaths. The reports mostly describe material that splits, cuts or tears, and a few mention fragments in the patient. There are 2 open recalls: broken or frayed grip cables on reusable instruments, and cracks that can let plastic fragments fall, possibly into the patient.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 340
- Deaths reported
- 0
- Injuries reported
- 20
- Recalls naming it
- 2
Summary
The FDA's MAUDE database contains 340 adverse event reports that list this exact device (DI 00886874111505), received between May 24, 2013 and Sep 30, 2026 — classified as 20 injuries, 320 malfunctions.
The most frequently reported specific device problem is “Material Split, Cut or Torn” (219 reports).
2 FDA recall records name this device's identifier, 2 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Recalls naming this device
- Dec 9, 2025Class IIOpen, Classified
Due to increased complaints for broken/frayed grip cables for reusable instruments.
Z-1696-2026 · Root cause: Process control · Recall details · FDA record ↗
- Aug 15, 2018Class IIOpen, Classified
Monopolar Curved Scissor (MCS) instruments may be susceptible to developing cracks near the proximal edge of the extension tube. These cracks may fracture the plastic surrounding the instrument shaft, and may cause fragments of the extension tube to fall, including potentially into the patient.
Z-3024-2018 · Root cause: Use error · Recall details · FDA record ↗
Most reported problems
Device problems
- Material Split, Cut or Torn219
- Material Fragmentation21
- Break15
- Unintended Movement15
- Detachment of Device or Device Component11
- No Apparent Adverse Event10
- Arcing8
- Difficult to Open or Close7
Patient problems
- No Clinical Signs, Symptoms or Conditions246
- Insufficient Information67
- Device Embedded In Tissue or Plaque7
- Foreign Body In Patient6
- Hemorrhage/Blood Loss/Bleeding4
- Unspecified Tissue Injury4
- Burn(s)3
- Abscess1
Recent adverse event reports
The 25 most recent of 340 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954541 ↗MalfunctionSep 29, 2026Material Split, Cut or Torn
It was reported that there was a broken cable with a da Vinci product. The customer reported event has no report of patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50928036 ↗MalfunctionSep 25, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50905531 ↗MalfunctionSep 23, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50875640 ↗MalfunctionSep 22, 2026Material Split, Cut or Torn
It was reported that there was a broken cable with a da Vinci product. The customer reported event has no report of patient injury.
Patient problems: Insufficient Information
MAUDE report 50850393 ↗MalfunctionSep 2, 2026High Readings
Patient problems: Hypoglycemia
MAUDE report 50575935 ↗MalfunctionAug 11, 2026Material Split, Cut or Torn
It was reported that there was a broken cable with a da Vinci product. The customer reported event has no report of patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50216102 ↗MalfunctionAug 11, 2026Material Split, Cut or Torn
It was reported that there was a broken cable with a da Vinci product. The customer reported event has no report of patient injury. Review of the provided image is consistent with broken cable.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50215975 ↗MalfunctionApr 28, 2026Material Split, Cut or Torn
IT WAS REPORTED THAT THERE WAS A BROKEN CABLE WITH A DA VINCI PRODUCT. THE CUSTOMER REPORTED EVENT HAS NO REPORT OF PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25022770 ↗MalfunctionApr 21, 2026Material Split, Cut or Torn
IT WAS REPORTED THAT THERE WAS A BROKEN CABLE WITH A DA VINCI PRODUCT. THE CUSTOMER REPORTED EVENT HAS NO REPORT OF PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24946319 ↗MalfunctionMar 26, 2026Unintended Movement
IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, ONLY ONE SIDE OF THE MONOPOLAR CURVED SCISSORS COULD BE MOVED. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CUSTOMER CONFIRMED THAT THE JAW OF THE INSTRUMENT WAS NOT STATIC IN THE OPEN POSITION, AND NO BROKEN CABLES WERE VISIBLE AT THE WRIST OF THE INSTRUMENT. THERE WERE NO REPORTS OF TISSUE INJURY CAUSED BY THE INSTRUMENT¿S JAWS, AND NO MATERIAL WAS FOUND MISSING OR DETACHED. ADDITIONALLY, NO PHOTOGRAPHIC OR VIDEO EVIDENCE WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24706772 ↗MalfunctionMar 19, 2026No Device Output
IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT WAS NOT RECOGNIZED. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24644283 ↗MalfunctionMar 19, 2026Unintended Movement
IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE JAWS OF 8 MM MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT COULD NOT BE OPENED. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24644280 ↗MalfunctionMar 13, 2026No Device Output
IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED AN ISSUE WITH AN INTUITIVE PRODUCT. THE CUSTOMER REPORTED EVENT HAS NO REPORT OF PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24594740 ↗MalfunctionMar 12, 2026Material Split, Cut or Torn
IT WAS REPORTED THAT THERE WAS A BROKEN CABLE WITH A DA VINCI PRODUCT. THE CUSTOMER REPORTED EVENT HAS NO REPORT OF PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24584860 ↗MalfunctionMar 12, 2026No Device Output
IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED AN ISSUE WITH AN INTUITIVE PRODUCT. THE CUSTOMER REPORTED EVENT HAS NO REPORT OF PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24584769 ↗MalfunctionMar 2, 2026Material Split, Cut or Torn
IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SIMPLE PROSTATECTOMY SURGICAL PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) HAD A BROKEN WIRE. THERE WAS A DELAY OF LESS THAN 15 MINUTES. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.
Patient problems: Insufficient Information
MAUDE report 24478527 ↗MalfunctionFeb 27, 2026Material Split, Cut or Torn
IT WAS REPORTED THAT THERE WAS A BROKEN CABLE WITH A DA VINCI PRODUCT. THE CUSTOMER REPORTED EVENT HAS NO REPORT OF PATIENT INJURY.
Patient problems: Insufficient Information
MAUDE report 24476352 ↗MalfunctionFeb 27, 2026Material Split, Cut or Torn
IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SURGEON REPORTED THE MONOPOLAR CURVED SCISSORS (MCS) DID NOT ROTATE COMPLETELY, WHEN MOVING THE CONTROLS IT WAS DIFFICULT TO ROTATE, BREAKING THE STEEL CABLE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24468314 ↗MalfunctionFeb 27, 2026Material Split, Cut or Torn
IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE MONOPOLAR CURVED SCISSORS "STOPPED WORKING WHILE DOING SURGERY ON 5TH LIFE." THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY USING A BACK-UP INSTRUMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24467736 ↗MalfunctionFeb 27, 2026Material Split, Cut or Torn
IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, IT WAS OBSERVED THAT CABLES BREAK DURING SURGERY, THERE WERE NO FORCED MOVEMENTS OR FRICTION WITH OTHER INSTRUMENTS, IT WAS REMOVED AND INSPECTED, SO IT WAS REPLACED WITH BACKUP INSTRUMENT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24467735 ↗MalfunctionFeb 27, 2026Material Split, Cut or Torn
IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, IT WAS OBSERVED THAT CABLES BREAK DURING SURGERY, THERE WERE NO FORCED MOVEMENTS OR FRICTION WITH OTHER INSTRUMENTS, IT WAS REMOVED AND INSPECTED, SO IT WAS REPLACED WITH BACKUP INSTRUMENT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24467546 ↗MalfunctionFeb 27, 2026No Apparent Adverse Event
IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED AN ISSUE WITH AN INTUITIVE PRODUCT. THE CUSTOMER REPORTED EVENT HAS NO REPORT OF PATIENT INJURY. ISI FOLLOWED UP WITH THE INITIAL REPORTER TO OBTAIN ADDITIONAL INFORMATION, HOWEVER, NO FURTHER DETAILS ARE AVAILABLE REGARDING THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24467157 ↗MalfunctionFeb 26, 2026Material Split, Cut or Torn
IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PROSTATECTOMY SURGICAL PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) HAD EXPOSED WIRING. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24453785 ↗MalfunctionFeb 26, 2026Unintended Movement
IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE JAWS OF THE MONOPOLAR CURVED SCISSORS (MCS) DID NOT OPEN OR CLOSE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24453109 ↗
Other System,surgical,computer controlled instrument devices
- EndoWrist 471205Intuitive Surgical, Inc. · System, surgical, computer controlled instrument1 recall14,225 reports
- EndoWrist 470179Intuitive Surgical, Inc. · System,surgical,computer controlled instrument2 recalls2 deaths10,156 reports
- EndoWrist 471093Intuitive Surgical, Inc. · System, surgical, computer controlled instrument1 recall8,581 reports
- EndoWrist 471172Intuitive Surgical, Inc. · System, surgical, computer controlled instrument1 recall1 death6,302 reports
- daVinci Xi 380652Intuitive Surgical, Inc. · System,surgical,computer controlled instrument2 recalls235 deaths5,316 reports
- daVinci Xi 381121Intuitive Surgical, Inc. · System,surgical,computer controlled instrument1 recall2 deaths4,310 reports
- EndoWrist 471405Intuitive Surgical, Inc. · System, surgical, computer controlled instrument1 recall1 death3,770 reports
- EndoWrist 470327Intuitive Surgical, Inc. · System,surgical,computer controlled instrument2 recalls2,273 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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