EndoWrist 471296Recalls & reported problems
Intuitive Surgical, Inc. · LARGE SUTURE CUT NEEDLE DRIVER · Class 2
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This EndoWrist Large Suture Cut needle driver from Intuitive Surgical has 1,397 FDA adverse event reports, with 71 injuries, 1,326 malfunctions and no deaths. The reports mostly describe torn, frayed or fragmented cables and materials, tips that break, and screws coming loose, with some mentioning parts ending up in patients. One open recall names this device; it began in December 2024 over more complaints of frayed or broken grip cables on reusable 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
- 1,392
- Deaths reported
- 0
- Injuries reported
- 72
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1,392 adverse event reports that list this exact device (DI 00886874121504), received between Jan 13, 2021 and Sep 30, 2026 — classified as 72 injuries, 1,320 malfunctions.
The most frequently reported specific device problem is “Material Split, Cut or Torn” (649 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-0879-2025 · Root cause: Process change control · FDA record ↗
Most reported problems
Device problems
- Material Split, Cut or Torn649
- Material Fragmentation400
- Material Frayed145
- Detachment of Device or Device Component78
- Break45
- No Apparent Adverse Event40
- Unintended Movement18
- Unintended System Motion14
Patient problems
- No Clinical Signs, Symptoms or Conditions1,082
- Insufficient Information289
- Foreign Body In Patient30
- Device Embedded In Tissue or Plaque2
- Unspecified Tissue Injury1
Recent adverse event reports
The 25 most recent of 1,392 reports, 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 50954543 ↗MalfunctionSep 30, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954338 ↗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 50942441 ↗MalfunctionSep 28, 2026Material Split, Cut or Torn
Patient problems: Insufficient Information
MAUDE report 50926060 ↗MalfunctionSep 25, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50905759 ↗MalfunctionSep 23, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50875248 ↗MalfunctionSep 22, 2026Failure to Cut
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50861019 ↗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: No Clinical Signs, Symptoms or Conditions
MAUDE report 50850359 ↗MalfunctionAug 28, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50508864 ↗MalfunctionAug 20, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50358495 ↗MalfunctionAug 20, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50358493 ↗MalfunctionAug 20, 2026Difficult to Open or Close
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50337769 ↗MalfunctionAug 19, 2026Entrapment of Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50332365 ↗MalfunctionAug 13, 2026Material Frayed
Patient problems: Insufficient Information
MAUDE report 50243677 ↗MalfunctionAug 11, 2026No Apparent Adverse Event
It was reported that the customer experienced an issue with an Intuitive product. The customer reported event has no report of patient injury. ISI followed up with the initial reporter to obtain additional information; however, no further details are available regarding the reported event.
Patient problems: Insufficient Information
MAUDE report 50203119 ↗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.ISI followed up with the initial reporter and obtained the following additional information: The procedure was completed with no patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50203092 ↗InjuryAug 10, 2026Detachment of Device or Device Component
It was alleged that during a da Vinci-assisted right hemicolectomy procedure, there was a loose grip on the needle and thread, and the needle was dropped into the patient's abdomen from the Large SutureCut Needle Driver. The needle was retrieved during the same procedure. The procedure was completed using a backup instrument.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50192402 ↗MalfunctionAug 7, 2026No Apparent Adverse Event
It was reported that the customer experienced an issue with an Intuitive product. The customer reported event has no report of patient injury.
Patient problems: Insufficient Information
MAUDE report 50183564 ↗MalfunctionAug 7, 2026Material Split, Cut or Torn
It was reported that the customer experienced an issue with an Intuitive product. The customer reported event has no report of patient injury.
Patient problems: Insufficient Information
MAUDE report 50183440 ↗InjuryAug 5, 2026Detachment of Device or Device Component; Difficult to Open or Close
It was reported that during a da Vinci-assisted pancreatoduodenectomy procedure, the Large SutureCut Needle Driver instrument did not hold the needle properly. The needle fell off inside the patient but was recovered immediately. The procedure was completed with a new Large SutureCut Needle Driver instrument after an approximate 5-minute delay.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50146855 ↗MalfunctionJul 31, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50107522 ↗MalfunctionMay 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 25324983 ↗MalfunctionMay 22, 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 25262337 ↗MalfunctionMay 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 25261991 ↗InjuryMay 14, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED UROLOGICAL PROCEDURE, THE NEEDLE WAS LOST IN THE TROCAR WHEN THE LARGE SUTURECUT NEEDLE DRIVER INSTRUMENT WAS BEING REMOVED. THE NEEDLE WAS NOT FOUND AFTER AN EXPLORATORY LAPAROSCOPY WAS PERFORMED. NO ADDITIONAL PORTS WERE PLACED IN ORDER TO PERFORM THE EXPLORATORY LAPAROSCOPY. THE PROCEDURE WAS COMPLETED WITH A 90-MINUTE DELAY.
Patient problems: Foreign Body In Patient
MAUDE report 25176223 ↗
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.