EndoWrist 470179Recalls & reported problems
Intuitive Surgical, Inc. · MONOPOLAR CURVED SCISSORS · Class 2
All models of EndoWrist (62)
Data updated Oct 16, 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 instrument for da Vinci systems is named in 10,184 adverse event reports, including 132 injuries and 2 deaths. The reports mostly describe torn or frayed cables, parts breaking, and instrument tips that get stuck and cannot be removed. Both of its 2 recalls are open, one about frayed grip cables and one about cracks that can let plastic fragments fall 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
- 10,156
- Deaths reported
- 2
- Injuries reported
- 133
- Recalls naming it
- 2
Summary
The FDA's MAUDE database contains 10,156 adverse event reports that list this exact device (DI 00886874112298), received between May 19, 2017 and Sep 30, 2026 — classified as 2 deaths, 133 injuries, 10,020 malfunctions.
The most frequently reported specific device problem is “Material Split, Cut or Torn” (7,104 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 16, 2026.
Reports received per month
Recalls naming this device
- Dec 19, 2024Open, Classified
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Z-0847-2025 · Root cause: Process change control · Recall details · FDA record ↗
- Aug 15, 2018Open, 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-3025-2018 · Root cause: Use error · Recall details · FDA record ↗
Most reported problems
Device problems
- Material Split, Cut or Torn7,104
- Material Fragmentation744
- Unintended Movement516
- Difficult to Open or Close441
- Break305
- Material Frayed274
- Detachment of Device or Device Component190
- No Apparent Adverse Event180
Patient problems
- No Clinical Signs, Symptoms or Conditions8,447
- Insufficient Information1,611
- Unspecified Tissue Injury31
- Foreign Body In Patient28
- Hemorrhage/Blood Loss/Bleeding25
- Burn(s)18
- Device Embedded In Tissue or Plaque11
- Perforation of Vessels9
Recent adverse event reports
The 25 most recent of 10,156 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 50954549 ↗MalfunctionSep 30, 2026Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954546 ↗MalfunctionSep 30, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954349 ↗MalfunctionSep 30, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954342 ↗MalfunctionSep 30, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954213 ↗MalfunctionSep 30, 2026Material Split, Cut or Torn
Patient problems: Insufficient Information
MAUDE report 50953695 ↗MalfunctionSep 30, 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 50942404 ↗MalfunctionSep 30, 2026Material Split, Cut or Torn
It was reported that during a da Vinci-assisted surgical procedure, the Monopolar Curved Scissors had broken conductor wire (black). The procedure was completing as planned with no reported injury.ISI followed up with the initial reporter and obtained the following additional information: Based on the structure of Monopolar Curved Scissors, conductor wire cannot be confirmed visually. Thus, report of ¿conductor wire damage¿ can be considered as ¿cable¿ damage.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50942379 ↗MalfunctionSep 29, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50939703 ↗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 50928027 ↗MalfunctionSep 28, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50926109 ↗MalfunctionSep 28, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50926107 ↗MalfunctionSep 28, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50926059 ↗MalfunctionSep 28, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50925883 ↗MalfunctionSep 28, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50925880 ↗MalfunctionSep 28, 2026Difficult to Open or Close; Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50925617 ↗MalfunctionSep 28, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50925555 ↗MalfunctionSep 28, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50925199 ↗MalfunctionSep 28, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50925197 ↗MalfunctionSep 28, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50925189 ↗MalfunctionSep 28, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50925185 ↗MalfunctionSep 28, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50925177 ↗MalfunctionSep 28, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50925003 ↗MalfunctionSep 28, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50924977 ↗MalfunctionSep 28, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50924660 ↗
Other System,surgical,computer controlled instrument devices
- EndoWrist 471205Intuitive Surgical, Inc. · System, surgical, computer controlled instrument1 recall14,225 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
- None 480275Intuitive Surgical, Inc. · System,surgical,computer controlled instrument1 death2,324 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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