EndoWrist 471172Recalls & reported problems
Intuitive Surgical, Inc. · MARYLAND BIPOLAR FORCEPS · Class 2
All models of EndoWrist (62)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This da Vinci EndoWrist Maryland bipolar forceps is a surgical instrument used with a robotic surgery system. Of its 6,301 reports, 1 describes a death and 87 describe injuries; many describe material that split, tore or frayed, and some mention parts melting or sparking. Reports fell from 3,287 in the prior year to 1,956 in the latest year. There is 1 open recall from December 2024 about frayed or broken grip cables on instruments with jaws.
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
- 6,302
- Deaths reported
- 1
- Injuries reported
- 87
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 6,302 adverse event reports that list this exact device (DI 00886874119792), received between Dec 20, 2020 and Sep 30, 2026 — classified as 1 death, 87 injuries, 6,214 malfunctions.
The most frequently reported specific device problem is “Material Split, Cut or Torn” (3,411 reports).
1 FDA recall record name this device's 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, 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-0876-2025 · Root cause: Process change control · Recall details · FDA record ↗
Most reported problems
Device problems
- Material Split, Cut or Torn3,411
- Thermal Decomposition of Device845
- Material Frayed689
- Material Fragmentation407
- Arcing223
- Break210
- Detachment of Device or Device Component150
- No Apparent Adverse Event136
Patient problems
- No Clinical Signs, Symptoms or Conditions5,075
- Insufficient Information1,182
- Hemorrhage/Blood Loss/Bleeding24
- Foreign Body In Patient20
- Unspecified Tissue Injury13
- Burn(s)4
- Cardiac Arrest2
- Laceration(s)2
Recent adverse event reports
The 25 most recent of 6,302 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Thermal Decomposition of Device
It was reported that during a da Vinci-assisted surgical procedure, the Maryland Bipolar Forceps Instrument had thermal damage to the pulley cover. The procedure was completing as planned with no reported injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954209 ↗MalfunctionSep 30, 2026Material Split, Cut or Torn
Patient problems: Insufficient Information
MAUDE report 50954094 ↗MalfunctionSep 30, 2026Scratched Material
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954088 ↗MalfunctionSep 30, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954084 ↗MalfunctionSep 30, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954069 ↗MalfunctionSep 30, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50953680 ↗MalfunctionSep 29, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50939340 ↗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 50928013 ↗MalfunctionSep 29, 2026Material Split, Cut or Torn
It was reported that after a da Vinci-assisted surgical procedure, the 8mm Maryland Bipolar Forceps instrument had a damaged conductor wire (black).The procedure was completed with no reported injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50928012 ↗MalfunctionSep 28, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50926016 ↗MalfunctionSep 28, 2026No Apparent Adverse Event
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50925978 ↗MalfunctionSep 28, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50925977 ↗MalfunctionSep 28, 2026Material Split, Cut or Torn
Patient problems: Insufficient Information
MAUDE report 50925334 ↗MalfunctionSep 28, 2026Material Frayed
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50925266 ↗MalfunctionSep 26, 2026Thermal Decomposition of Device
It was reported that during central processing, the tip of a Maryland Bipolar Forceps instrument had the coating burnt off. There was no report of patient involvement.Intuitive Surgical, Inc. (ISI) followed up with the initial reporter to obtain additional information: The customer indicated that no arcing was observed during the last procedure, no patient injury occurred
Patient problems: Insufficient Information
MAUDE report 50906721 ↗MalfunctionSep 25, 2026Material Frayed
Patient problems: Insufficient Information
MAUDE report 50905790 ↗MalfunctionSep 25, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50905517 ↗MalfunctionSep 25, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50905023 ↗MalfunctionSep 25, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50904545 ↗MalfunctionSep 25, 2026Material Frayed
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50904544 ↗MalfunctionSep 25, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50904512 ↗MalfunctionSep 25, 2026Material Split, Cut or Torn
It was reported that during a da Vinci-assisted surgical procedure, a Maryland Bipolar Forceps failed to perform its opening and closing function properly. It was not conducting energy. Upon inspection, it was observed that the wires were broken. The procedure was completed with no reported injury.Intuitive followed up and obtained additional information. The broken wires were the metallic wires controlling the movements of the instrument. No signs of thermal damage were observed at the site of breakage. No arcing was observed during the procedure. No photos were available since instrument was sent back.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50893579 ↗MalfunctionSep 24, 2026Thermal Decomposition of Device
It was reported that during a da Vinci-assisted surgical procedure, a Maryland Bipolar Forceps had energization failure, burn marks on the contact area of the forceps tip wire. The procedure was completing as planned with no reported injury.Intuitive Surgical, Inc. (ISI) contacted the customer and obtained the following information: Arcing was not reported and the staff do not remember it happened. There was no injury to the patient.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50891012 ↗MalfunctionSep 24, 2026Material Fragmentation
Patient problems: Insufficient Information
MAUDE report 50890777 ↗InjurySep 24, 2026Material Fragmentation
It was reported that during a da Vinci-assisted radical prostatectomy without lymphadenectomy procedure, the Maryland Bipolar Forceps instrument broke due to a collision with ProGrasp forceps. A fragment from the Maryland Bipolar fell into the patient and was retrieved during the same procedure. The procedure was completed.Intuitive Surgical, Inc. (ISI) made multiple follow-up attempts to obtain additional information. However, no further details have been received as of the date of this report.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50883699 ↗
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
- 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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