EndoWrist 471205Recalls & reported problems
Intuitive Surgical, Inc. · FENESTRATED BIPOLAR FORCEPS · Class 2
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This da Vinci EndoWrist fenestrated bipolar forceps has 14,291 adverse event reports, with no deaths and 255 injuries. Most describe parts that split, tear or fray, and some describe fragments coming loose. A few reports mention bleeding or a foreign body in the patient. There is 1 open recall, from December 2024, for frayed or broken grip cables on reusable jawed instruments.
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
- 14,225
- Deaths reported
- 0
- Injuries reported
- 256
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 14,225 adverse event reports that list this exact device (DI 00886874119808), received between Jan 11, 2021 and Sep 30, 2026 — classified as 256 injuries, 13,968 malfunctions.
The most frequently reported specific device problem is “Material Split, Cut or Torn” (8,650 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. How this data works · Data updated Oct 13, 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-0878-2025 · Root cause: Process change control · FDA record ↗
Most reported problems
Device problems
- Material Split, Cut or Torn8,650
- Material Frayed1,630
- Material Fragmentation1,235
- Thermal Decomposition of Device658
- Break570
- No Apparent Adverse Event418
- Detachment of Device or Device Component391
- Unintended Movement205
Patient problems
- No Clinical Signs, Symptoms or Conditions11,060
- Insufficient Information3,056
- Foreign Body In Patient82
- Hemorrhage/Blood Loss/Bleeding38
- Unspecified Tissue Injury33
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Burn(s)2
- Great Vessel Perforation2
Recent adverse event reports
The 25 most recent of 14,225 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Material Split, Cut or Torn
Patient problems: Insufficient Information
MAUDE report 50954551 ↗MalfunctionSep 30, 2026Material Twisted/Bent
Patient problems: Insufficient Information
MAUDE report 50954545 ↗MalfunctionSep 30, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954358 ↗MalfunctionSep 30, 2026Material Split, Cut or Torn
Patient problems: Insufficient Information
MAUDE report 50954327 ↗MalfunctionSep 30, 2026Material Split, Cut or Torn
Patient problems: Insufficient Information
MAUDE report 50954312 ↗MalfunctionSep 30, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954306 ↗MalfunctionSep 30, 2026Material Split, Cut or Torn
Patient problems: Insufficient Information
MAUDE report 50954302 ↗MalfunctionSep 30, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50953897 ↗MalfunctionSep 30, 2026Arcing
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50953893 ↗MalfunctionSep 30, 2026Unintended Movement
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50953888 ↗MalfunctionSep 30, 2026Thermal Decomposition of Device
It was reported that during central processing, the Fenestrated Bipolar Forceps instrument had thermal damage to the pulley cover. No known impact or patient consequence was reported.
Patient problems: Insufficient Information
MAUDE report 50953699 ↗MalfunctionSep 30, 2026Material Split, Cut or Torn
Patient problems: Insufficient Information
MAUDE report 50953692 ↗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: No Clinical Signs, Symptoms or Conditions
MAUDE report 50942440 ↗MalfunctionSep 30, 2026Material Frayed
It was reported that there was a frayed cable with a da Vinci product. The customer reported event has no report of patient injury.
Patient problems: Insufficient Information
MAUDE report 50942408 ↗MalfunctionSep 30, 2026Material Frayed
It was reported that there was a frayed 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 50942384 ↗MalfunctionSep 30, 2026Material Frayed
It was reported that there was a frayed 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 50942382 ↗MalfunctionSep 29, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50939654 ↗MalfunctionSep 29, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50939645 ↗MalfunctionSep 29, 2026Material Split, Cut or Torn
Patient problems: Insufficient Information
MAUDE report 50939573 ↗MalfunctionSep 29, 2026Material Split, Cut or Torn
Patient problems: Insufficient Information
MAUDE report 50939482 ↗MalfunctionSep 29, 2026Unintended Movement
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50939470 ↗MalfunctionSep 29, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50939236 ↗MalfunctionSep 29, 2026Difficult to Remove
It was reported that during a da Vinci-assisted pelvic exenteration surgical procedure, the Fenestrated Bipolar Forceps instrument did not respond to the surgeon's commands and became stuck inside the patient's cavity. The customer was unable to remove it with the safety key. The customer utilized all skills to attempt removal but had to remove the trocar along with the forceps, making it necessary to open a new instrument set to complete the surgery.Intuitive Surgical, Inc. (ISI) performed follow-up and obtained the following additional information regarding the reported event: The instrument would not move, and a nurse was brought in to do everything possible to free the instrument. The surgeon confirmed the patient suffered no harm. At the time of this report, the reason for the use of the Instrument Release Kit (IRK) has not yet been determined.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50936287 ↗MalfunctionSep 29, 2026Thermal Decomposition of Device
It was reported that during central processing, a Fenestrated Bipolar Forceps instrument was observed with a tear in the black coating at the tip. There was no report of patient involvement or patient injury.
Patient problems: Insufficient Information
MAUDE report 50928037 ↗MalfunctionSep 29, 2026No Apparent Adverse Event
It was reported that during a procedure with the da Vinci X/Xi system, an issue was identified involving an 8mm fenestrated bipolar forceps. The complaint noted the instrument was tagged as damaged, with no further information provided.The procedure was completed with no report of patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50928018 ↗
Other System, surgical, computer controlled instrument devices
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- 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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.