EndoWrist SPRecalls & reported problems across all models
Intuitive Surgical, Inc. · 20 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one EndoWrist SP model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 993
- Deaths reported
- 0
- Injuries reported
- 142
- Recalls
- 1
We found 20 models of EndoWrist SP by Intuitive Surgical, Inc. in the FDA's device registry (GUDID). Together they are named in 993 adverse event reports in the FDA's MAUDE database, received between May 12, 2020 and Sep 29, 2026 — classified as 142 injuries, 851 malfunctions.
The most frequently reported specific device problem is “Break” (361 reports).
1 FDA recall record name at least one of these models by its device identifier, 1 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 SP 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.
- Aug 19, 2019Open, Classified
Some cameras were found to have residual soil adhered to the tip of the camera after reprocessing which may affect image quality resulting in needing to switch to a second camera or converting to another surgical modality. If residual soil makes contact with the patient, exposure could result in sensitization making future component blood therapy or tissue typing more challenging; additionally if a small piece of inert epoxy were to be retained, scar tissue could form.
Z-2131-2020 · Root cause: Process control · Recall details · FDA record ↗
Most reported EndoWrist SP problems
Device problems
- Break361
- Detachment of Device or Device Component191
- Unintended System Motion87
- Material Fragmentation81
- Unintended Movement45
- No Apparent Adverse Event42
- Thermal Decomposition of Device36
- Difficult to Open or Close27
Patient problems
- No Clinical Signs, Symptoms or Conditions730
- Insufficient Information173
- Foreign Body In Patient59
- Unspecified Tissue Injury18
- Hemorrhage/Blood Loss/Bleeding11
- No Known Impact Or Consequence To Patient4
- Skin Discoloration2
- Abdominal Pain1
EndoWrist SP models
20 models, most reported first. Each model has its own page with its reports, recalls and device details.
- EndoWrist SP 430004System, surgical, computer controlled instrument356 reports
- EndoWrist SP 430011System, surgical, computer controlled instrument170 reports
- EndoWrist SP 430007System, surgical, computer controlled instrument147 reports
- EndoWrist SP 430010System, surgical, computer controlled instrument100 reports
- EndoWrist SP 430060System, surgical, computer controlled instrument1 recall10 reports
- Endowrist SP 430077System, x-ray, angiographic31 reports
- EndoWrist SP 430006System, surgical, computer controlled instrument28 reports
- EndoWrist SP 430005System, surgical, computer controlled instrument26 reports
- EndoWrist SP 431150System, surgical, computer controlled instrument25 reports
- EndoWrist SP 430009System, surgical, computer controlled instrument20 reports
- EndoWrist SP 430151System, surgical, computer controlled instrument19 reports
- EndoWrist SP 430100System, surgical, computer controlled instrument19 reports
- EndoWrist SP 431100System, surgical, computer controlled instrument17 reports
- EndoWrist SP 430152System, surgical, computer controlled instrument11 reports
- EndoWrist SP 430101System, surgical, computer controlled instrument7 reports
- EndoWrist SP 430200System, surgical, computer controlled instrument2 reports
- EndoWrist SP 430300System, surgical, computer controlled instrument2 reports
- EndoWrist SP 431200System, surgical, computer controlled instrument1 report
- EndoWrist SP 431152System, surgical, computer controlled instrument1 report
- EndoWrist SP 430250System, surgical, computer controlled instrument1 report
Recent EndoWrist SP adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 29, 2026Entrapment of Device
Patient problems: Unspecified Tissue Injury
MAUDE report 50941331 ↗MalfunctionSep 29, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50939853 ↗MalfunctionSep 29, 2026Unintended System Motion
It was reported that during a da Vinci-assisted surgical procedure, the Single Port (SP) Needle Driver instrument was not responding to the commands.The procedure was completed with no reported injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50928531 ↗MalfunctionSep 29, 2026Unintended Movement
It was reported that prior to starting a da Vinci-assisted Urology surgical procedure, a Monopolar Curved Scissors (MCS) instrument exhibited non intuitive motion. The customer continued with the procedure as planned, and no patient impact or consequence was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50927526 ↗MalfunctionSep 28, 2026Unintended Movement
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50926647 ↗MalfunctionSep 28, 2026Break
Patient problems: Insufficient Information
MAUDE report 50926015 ↗MalfunctionSep 28, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50925536 ↗MalfunctionSep 28, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50925354 ↗MalfunctionSep 28, 2026Break
It was reported that during central processing, the user reported that the tip of a Single Port Monopolar Curved Scissors instrument was broken. There was no report of patient involvement or patient injury.
Patient problems: Insufficient Information
MAUDE report 50910834 ↗MalfunctionSep 25, 2026Unintended Movement
It was reported that during a da Vinci-assisted a Single Port (SP) Cadiere Forcep instrument did not move in the same direction as the surgeon¿s console hand control. The procedure was completed with no reported injury.Intuitive Surgical, Inc. (ISI) followed up with the initial reporter and obtained the following additional information: The instrument moved in an unintended direction. The instrument was replaced with a backup instrument.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50895696 ↗MalfunctionSep 25, 2026Unintended Movement
It was reported that during a da Vinci-assisted surgical procedure, the joint was not bending properly and kept moving differently from the console input. Customer tried detaching it to reassemble the sheath, and replaced it with a new one, but the same issue persisted. After switching to a different Monopolar Curved Scissors arm, it functioned correctly.The procedure was completed with no reported injury.
Patient problems: Insufficient Information
MAUDE report 50895164 ↗MalfunctionSep 24, 2026Entrapment of Device
It was reported that during a da Vinci-assisted surgical procedure, the Single Port (SP) Force Bipolar instrument jammed in the closed position, trapping tissue and making it impossible to open.The procedure was completed with no reported injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50886482 ↗MalfunctionSep 23, 2026Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50875245 ↗MalfunctionSep 23, 2026Difficult to Open or Close
It was reported that after a da Vinci-assisted surgical procedure, the customer observed the 6mm Force Bipolar instrument's button which allows the jaws to open was not holding. No known impact or patient consequence was reported. Intuitive Surgical Inc. (ISI) followed up with the customer: It was confirmed the instrument jaws were stuck in the closed position.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50873341 ↗MalfunctionSep 23, 2026Material Twisted/Bent
It was reported that during a da Vinci-assisted surgical procedure, Single Port (SP) Fenestrated Bipolar Forceps instrument had misaligned jaws.The procedure was completed with no reported injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50864100 ↗
Other Intuitive Surgical, Inc. products
- EndoWrist62 models · 69,753 reports · 48 recalls
- daVinci Xi4 models · 11,477 reports · 3 recalls
- EndoWrist;daVinci Si35 models · 1,683 reports · 8 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
- 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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