Endowrist 480422Recalls & reported problems
Intuitive Surgical, Inc. · VESSEL SEALER EXTEND · Class 2
All models of EndoWrist (62)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Intuitive Vessel Sealer Extend is a robot-held instrument for da Vinci surgery. Of its 1,788 reports, many describe jaws that are hard to open or close, energy not reaching the tissue and seals that do not hold, with 11 deaths and 349 injuries recorded. There is 1 closed recall, from March 2022, about too much tissue placed in the jaws, which can cause an incomplete seal.
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
- 1,790
- Deaths reported
- 11
- Injuries reported
- 354
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1,790 adverse event reports that list this exact device (DI 00886874115664), received between Jul 20, 2018 and Sep 30, 2026 — classified as 11 deaths, 354 injuries, 1,425 malfunctions.
The most frequently reported specific device problem is “Difficult to Open or Close” (464 reports).
1 FDA recall record name this device's identifier.
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
- Mar 3, 2022Completed
Placing excessive tissue in the instrument jaws of the devices prior to sealing and transection can result in an insufficient seal.
Z-1209-2022 · Root cause: Use error · Recall details · FDA record ↗
Most reported problems
Device problems
- Difficult to Open or Close464
- Failure to Deliver Energy437
- Failure to Seal150
- Unintended System Motion139
- Detachment of Device or Device Component116
- Material Fragmentation73
- Break62
- Unintended Movement59
Patient problems
- No Clinical Signs, Symptoms or Conditions1,271
- Hemorrhage/Blood Loss/Bleeding182
- Insufficient Information124
- No Known Impact Or Consequence To Patient88
- Unspecified Tissue Injury68
- Foreign Body In Patient66
- Blood Loss13
- Device Embedded In Tissue or Plaque9
Recent adverse event reports
The 25 most recent of 1,790 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Difficult to Open or Close
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950121 ↗MalfunctionSep 29, 2026Failure to Seal
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50938561 ↗MalfunctionSep 29, 2026Appropriate Device Problem Term/Code Not Available
Patient problems: Insufficient Information
MAUDE report 50936723 ↗MalfunctionSep 29, 2026Unintended System Motion
Patient problems: Insufficient Information
MAUDE report 50935711 ↗MalfunctionSep 28, 2026Material Fragmentation; No Device Output
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50926585 ↗MalfunctionSep 28, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50926120 ↗MalfunctionSep 28, 2026Device Dislodged or Dislocated
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50924082 ↗MalfunctionSep 28, 2026Unintended System Motion
It was reported that during a da Vinci-assisted sigmoid colectomy surgical procedure, the jaws of the Vessel Sealer Extend (VSE) instrument were closed and the instrument jolted. The surgeon was not moving the Master Tool Manipulators (MTM) at the time, and no tissue was grasped. The instrument was reseated; however, the issue persisted. Use of the instrument was discontinued and the instrument was replaced with a backup. The procedure was completed as planned, and no reported injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50917971 ↗InjurySep 28, 2026Physical Resistance/Sticking
It was reported that during a da Vinci-assisted right hemicolectomy surgical procedure, while using the Vessel Sealer Extend (VSE) instrument, the instrument was not sealing and gave an error indicating a non-complete sealing cycle. Tissue was adhered to the instrument which caused tissue damage and bleeding. Tissue was never cut that was not fully sealed and the instrument was noted to work ¿sometimes¿ with audible tones. The procedure was converted to laparoscopic with no additional ports placed. Information surrounding how the patient tolerated the change in surgery was not known.
Patient problems: Hemorrhage/Blood Loss/Bleeding; Unspecified Tissue Injury
MAUDE report 50915266 ↗MalfunctionSep 28, 2026Retraction Problem; Mechanical Jam
From Staff: Vessel Sealer abruptly stopped cutting. Error message stated the blade was still exposed upon removal. Sharp has been wrapped with a surgical towel and taped. Item removed from the field, new one opened. From Operative Report:
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50914824 ↗InjurySep 28, 2026Physical Resistance/Sticking
It was reported that during a da Vinci-assisted right hemicolectomy surgical procedure, while using the Vessel Sealer Extend (VSE) instrument, the instrument was not sealing and gave an error indicating a non-complete sealing cycle. Tissue was adhered to the instrument which caused tissue damage and bleeding. Tissue was never cut that was not fully sealed and the instrument was noted to work ¿sometimes¿ with audible tones. The procedure was converted to laparoscopic with no additional ports placed. Information surrounding how the patient tolerated the change in surgery was not known.
Patient problems: Hemorrhage/Blood Loss/Bleeding; Unspecified Tissue Injury
MAUDE report 50914741 ↗MalfunctionSep 26, 2026Physical Resistance/Sticking
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50906718 ↗MalfunctionSep 25, 2026Unintended Movement
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50905518 ↗InjurySep 25, 2026Failure to Deliver Energy; Failure to Seal
It was reported that during a da Vinci-assisted total gastrectomy procedure, after sealing with the Vessel Sealer Extend (VSE) instrument, unexpected bleeding was observed from the omentum. The amount of blood loss was not provided. No blood transfusions were administered, and the bleeding was controlled using a Fenestrated Bipolar Forceps (FBF) instrument. The procedure was completed.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 50897744 ↗MalfunctionSep 25, 2026Packaging Problem
It was reported that during a da Vinci-assisted left hemicolectomy surgical procedure, both of the blue sealing strips on the 8mm Vessel Sealer Extend (VSE) instrument had come off. No fragment fell into the patient. The user completed the procedure and no known impact or patient consequence was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50893643 ↗MalfunctionSep 24, 2026Unintended System Motion
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50889778 ↗MalfunctionSep 24, 2026Device Dislodged or Dislocated; Failure to Seal
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50889099 ↗MalfunctionSep 24, 2026Difficult to Open or Close
It was reported that during a daVinci assisted surgical procedure, the customer identified that the Vessel Sealer Extend (VSE) instrument was defective. The procedure was completed with no reported injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50878874 ↗MalfunctionSep 23, 2026Material Split, Cut or Torn
Patient problems: Insufficient Information
MAUDE report 50874535 ↗MalfunctionSep 23, 2026No Apparent Adverse Event
It was reported that the 8mm Vessel Sealer Extend instrument had a different lot number. There was no report of patient involvement or patient injury.
Patient problems: Insufficient Information
MAUDE report 50872133 ↗MalfunctionSep 22, 2026Failure to Seal
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50861275 ↗MalfunctionAug 11, 2026Difficult to Open or Close
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50216968 ↗MalfunctionAug 11, 2026Unintended System Motion
It was reported that during a da Vinci-assisted surgical procedure, the Vessel Sealer Extend (VSE) instrument installed on Universal Surgical Manipulator (USM) 4 was not opening and closing the tips. The customer manually closed the VSE instrument using the release mechanism while the surgeon activated the energy. The customer stated that prior to calling Technical Support Engineer (TSE) for troubleshooting assistance, they tried to reset the VSE instrument, but the issue persisted. The TSE asked if it was possible to change the VSE instrument and customer stated that it was not possible. During a second call, the customer plugged the cable for live logs. The TSE suggested to verify the VSE instrument during other procedure. Logs did not show any errors. The procedure was completed and no known impact or patient consequence was reported. Intuitive Surgical, Inc. (ISI) followed up with the initial reporter and obtained the following additional information: The Vessel Sealer Extend (VSE) instrument was inspected prior to use and nothing out of the ordinary was observed. The complete VSE instrument batch number was no longer available. The VSE instrument did not work at all (sealed su
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50214930 ↗MalfunctionAug 11, 2026Difficult to Open or Close
It was reported that during a daVinci assisted surgical procedure, the customer identified that the Vessel Sealer Extend Instrument was not working. The procedure was completed with no reported injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50212406 ↗MalfunctionAug 11, 2026Difficult to Open or Close
It was reported that during a da Vinci-assisted benign hysterectomy surgical procedure, the Vessel Sealer Extend instrument did not work while inside of the patient. The customer was unable to open the jaws.
Patient problems: Insufficient Information
MAUDE report 50204342 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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