EndoWrist;daVinci SiRecalls & reported problems across all models
Intuitive Surgical, Inc. · 35 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
8 open recalls name at least one EndoWrist;daVinci Si model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1,683
- Deaths reported
- 0
- Injuries reported
- 115
- Recalls
- 8
We found 35 models of EndoWrist;daVinci Si by Intuitive Surgical, Inc. in the FDA's device registry (GUDID). Together they are named in 1,683 adverse event reports in the FDA's MAUDE database, received between May 24, 2013 and Sep 30, 2026 — classified as 115 injuries, 1,565 malfunctions.
The most frequently reported specific device problem is “Material Split, Cut or Torn” (443 reports).
8 FDA recall records name at least one of these models by its device identifier, 8 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
EndoWrist;daVinci Si recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Dec 9, 2025Open, Classified
Due to increased in complaints regarding frayed or broken pitch cables on reusable surgical instruments
Z-1701-2026 · Root cause: Process change control · Recall details · FDA record ↗
- Dec 9, 2025Open, Classified
Due to increased in complaints regarding frayed or broken pitch cables on reusable surgical instruments
Z-1700-2026 · Root cause: Process change control · Recall details · FDA record ↗
- Dec 9, 2025Open, Classified
Due to increased complaints for broken/frayed grip cables for reusable instruments.
Z-1699-2026 · Root cause: Process control · Recall details · FDA record ↗
- Dec 9, 2025Open, Classified
Due to increased complaints for broken/frayed grip cables for reusable instruments.
Z-1698-2026 · Root cause: Process control · Recall details · FDA record ↗
- Dec 9, 2025Open, Classified
Due to increased complaints for broken/frayed grip cables for reusable instruments.
Z-1697-2026 · Root cause: Process control · Recall details · FDA record ↗
- Dec 9, 2025Open, Classified
Due to increased complaints for broken/frayed grip cables for reusable instruments.
Z-1696-2026 · Root cause: Process control · Recall details · FDA record ↗
- Jul 1, 2022Open, Classified
Due to the potential for unexpected motion caused by the partial disengagement of the instrument from the system.
Z-1459-2022 · Root cause: Nonconforming Material/Component · names 3 of these models · 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-3024-2018 · Root cause: Use error · Recall details · FDA record ↗
Most reported EndoWrist;daVinci Si problems
Device problems
- Material Split, Cut or Torn443
- Break401
- Detachment of Device or Device Component201
- Arcing146
- Thermal Decomposition of Device144
- Material Fragmentation97
- Difficult to Open or Close66
- Unintended System Motion54
Patient problems
- No Clinical Signs, Symptoms or Conditions1,012
- No Known Impact Or Consequence To Patient435
- Insufficient Information125
- Device Embedded In Tissue or Plaque30
- Foreign Body In Patient27
- Hemorrhage/Blood Loss/Bleeding15
- Unspecified Tissue Injury12
- Blood Loss11
EndoWrist;daVinci Si models
35 models, most reported first. Each model has its own page with its reports, recalls and device details.
- EndoWrist;daVinci Si 420179System,surgical,computer controlled instrument2 recalls340 reports
- EndoWrist;daVinci Si 420205System,surgical,computer controlled instrument246 reports
- EndoWrist;daVinci Si 420183System,surgical,computer controlled instrument1 recall193 reports
- EndoWrist;daVinci Si 420172System,surgical,computer controlled instrument188 reports
- EndoWrist;daVinci Si 420207System,surgical,computer controlled instrument1 recall136 reports
- EndoWrist;daVinci Si 420184System,surgical,computer controlled instrument123 reports
- EndoWrist;daVinci Si 420194System,surgical,computer controlled instrument1 recall24 reports
- EndoWrist;daVinci Si 420230System,surgical,computer controlled instrument1 recall18 reports
- EndoWrist;daVinci Si 420189System,surgical,computer controlled instrument1 recall16 reports
- EndoWrist;daVinci Si 420093System,surgical,computer controlled instrument63 reports
- EndoWrist;daVinci Si 420327System,surgical,computer controlled instrument1 recall10 reports
- EndoWrist;daVinci Si 420006System,surgical,computer controlled instrument59 reports
- EndoWrist;daVinci Si 420278System,surgical,computer controlled instrument1 recall8 reports
- EndoWrist;daVinci Si 410322System,surgical,computer controlled instrument56 reports
- EndoWrist;daVinci Si 420003System,surgical,computer controlled instrument1 recall5 reports
- EndoWrist;daVinci Si 420318System,surgical,computer controlled instrument55 reports
- EndoWrist;daVinci Si 420049System,surgical,computer controlled instrument40 reports
- EndoWrist;daVinci Si 420227System,surgical,computer controlled instrument27 reports
- EndoWrist;daVinci Si 410298System,surgical,computer controlled instrument14 reports
- EndoWrist;daVinci Si 420110System,surgical,computer controlled instrument11 reports
- EndoWrist;daVinci Si 420309System,surgical,computer controlled instrument9 reports
- EndoWrist;daVinci Si 420142System,surgical,computer controlled instrument6 reports
- EndoWrist;daVinci Si 420143System,surgical,computer controlled instrument6 reports
- EndoWrist;daVinci Si 420275System,surgical,computer controlled instrument6 reports
- EndoWrist;daVinci Si 420296System,surgical,computer controlled instrument6 reports
- EndoWrist;daVinci Si 420190System,surgical,computer controlled instrument4 reports
- EndoWrist;daVinci Si 420142System, surgical, computer controlled instrument3 reports
- EndoWrist;daVinci Si 410299System,surgical,computer controlled instrument2 reports
- EndoWrist;daVinci Si 420117System,surgical,computer controlled instrument2 reports
- EndoWrist;daVinci Si 420344System,surgical,computer controlled instrument2 reports
- EndoWrist;daVinci Si 420033System,surgical,computer controlled instrument1 report
- EndoWrist;daVinci Si 420177System,surgical,computer controlled instrument1 report
- EndoWrist;daVinci Si 420178System,surgical,computer controlled instrument1 report
- EndoWrist;daVinci Si 420246System,surgical,computer controlled instrument1 report
- EndoWrist;daVinci Si 420274System,surgical,computer controlled instrument1 report
Recent EndoWrist;daVinci Si adverse event reports
The 15 most recent reports across all models, 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 ↗OtherSep 29, 2026Arcing
It was reported that during a da Vinci-assisted surgical procedure, the lead surgeon noticed sparks coming from the tip of the Fenestrated Bipolar Forceps instrument while performing uterine coagulation. The arcing appeared to originate from equipment, wrists, insulating materials and places. The arc grounded on patient anatomy when the bipolar energy was activated. Burnt insulation was noticed. The instrument tips did not collide with any other instrument or tool during procedure. It was reported that there was no patient injury. The procedure was completed as planned.
Patient problems: Insufficient Information
MAUDE report 50933194 ↗OtherSep 29, 2026Arcing
It was reported that during a da Vinci-assisted surgical procedure, customer noticed sparks coming from the Permanent Cautery Spatula instrument insulation of the electrocautery tip while clearing pelvic lymph nodes. The procedure was completed with no reported injury. The arcing appear to originate/occur from equipment, wrists, insulating materials and places. The arc grounded on patient anatomy when the monopolar Coag energy was activated. Burnt insulation was noticed on the instrument. The instrument tips did not collide with any other instrument or tool during procedure. It was reported that there was no injury to the patient. The procedure was completed as planned.
Patient problems: Insufficient Information
MAUDE report 50931441 ↗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 50875649 ↗MalfunctionSep 23, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50875640 ↗MalfunctionSep 23, 2026Material Split, Cut or Torn
Patient problems: Insufficient Information
MAUDE report 50875033 ↗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 ↗OtherSep 1, 2026Thermal Decomposition of Device; Arcing
Patient problems: Burn(s); Insufficient Information
MAUDE report 50542044 ↗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 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 25022371 ↗
Other Intuitive Surgical, Inc. products
- EndoWrist62 models · 69,753 reports · 48 recalls
- daVinci Xi4 models · 11,477 reports · 3 recalls
- daVinci 53 models · 1,608 reports · 5 recalls
- da Vinci Surgical System9 models · 1,459 reports · 5 recalls
- Ion6 models · 1,367 reports · 3 recalls
- SureForm16 models · 1,190 reports · 3 recalls
- EndoWrist SP20 models · 993 reports · 1 recall
- daVinci Si8 models · 681 reports · 1 recall
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- 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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