EndoWrist 470318Recalls & reported problems
Intuitive Surgical, Inc. · SMALL GRASPING RETRACTOR · Class 2
All models of EndoWrist (62)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Intuitive EndoWrist small grasping retractor is a robotic instrument used with da Vinci systems. Of its 1,114 reports, 29 describe injuries and 1,085 describe malfunctions, with no deaths. Many reports describe parts that break, split or detach, and some mention pieces left in the patient. Reports fell to 115 in the last 12 months from 343 in the previous 12 months. 2 open recalls, both from December 2024, cover frayed or broken cables.
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
- 1,117
- Deaths reported
- 0
- Injuries reported
- 29
- Recalls naming it
- 2
Summary
The FDA's MAUDE database contains 1,117 adverse event reports that list this exact device (DI 00886874112441), received between Dec 8, 2016 and Sep 29, 2026 — classified as 29 injuries, 1,088 malfunctions.
The most frequently reported specific device problem is “Material Fragmentation” (347 reports).
2 FDA recall records name this device's identifier, 2 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 18, 2026.
Reports received per month
Recalls naming this device
- Dec 19, 2024Class IIOpen, Classified
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Z-0866-2025 · Root cause: Process change control · Recall details · FDA record ↗
- Dec 19, 2024Class IIOpen, Classified
Due to an increase in complaints for pitch cable failures related to forceps and small Graptor instruments
Z-0924-2025 · Root cause: Device Design · Recall details · FDA record ↗
Most reported problems
Device problems
- Material Fragmentation347
- Material Split, Cut or Torn255
- Detachment of Device or Device Component231
- Break165
- Material Frayed118
- No Apparent Adverse Event24
- Detachment Of Device Component16
- Difficult to Open or Close8
Patient problems
- No Clinical Signs, Symptoms or Conditions740
- Insufficient Information216
- No Known Impact Or Consequence To Patient140
- Foreign Body In Patient15
- Device Embedded In Tissue or Plaque3
- Unspecified Tissue Injury2
- Failure to Anastomose1
- Hemorrhage/Blood Loss/Bleeding1
Recent adverse event reports
The 25 most recent of 1,117 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 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 50928016 ↗MalfunctionSep 25, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50905844 ↗MalfunctionSep 25, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50905837 ↗MalfunctionSep 25, 2026No Device Output
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50904355 ↗MalfunctionSep 9, 2026Material Split, Cut or Torn
Patient problems: Insufficient Information
MAUDE report 50700932 ↗MalfunctionAug 28, 2026Material Split, Cut or Torn
Patient problems: Insufficient Information
MAUDE report 50509252 ↗MalfunctionAug 13, 2026Material Frayed
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50243667 ↗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.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50215477 ↗MalfunctionAug 7, 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 50183842 ↗MalfunctionAug 7, 2026Material Frayed
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 50183560 ↗MalfunctionMay 28, 2026Difficult to Open or Close
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: No Clinical Signs, Symptoms or Conditions
MAUDE report 25325039 ↗MalfunctionMay 26, 2026Material Frayed
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 25291492 ↗MalfunctionMay 12, 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 25155481 ↗MalfunctionMay 4, 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 25074555 ↗MalfunctionMay 4, 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 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: Insufficient Information
MAUDE report 25074302 ↗MalfunctionApr 30, 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 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: Insufficient Information
MAUDE report 25052027 ↗MalfunctionApr 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 25051589 ↗MalfunctionApr 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 25029161 ↗MalfunctionApr 17, 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 24918329 ↗MalfunctionApr 17, 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 24918327 ↗MalfunctionApr 14, 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 24878955 ↗MalfunctionApr 11, 2026Material Frayed
REFER TO H11 FOR FOLLOW-UP INFORMATION.
Patient problems: Insufficient Information
MAUDE report 24848713 ↗MalfunctionApr 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. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE PRODUCT RECEIVED AT INTUITIVE 1/21.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24810276 ↗MalfunctionMar 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: Insufficient Information
MAUDE report 24737886 ↗MalfunctionMar 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 24721491 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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