EndoWrist;daVinci Si 420033Recalls & reported problems
Intuitive Surgical, Inc. · BLACK DIAMOND MICRO FORCEPS · Class 2
All models of EndoWrist;daVinci Si (35)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00886874111307), received between Nov 19, 2024 and Nov 19, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Fragmentation” (1 report).
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
Most reported problems
Device problems
- Material Fragmentation1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 19, 2024Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SURGEON FELT THAT THE BLACK DIAMOND MICRO FORCEPS INSTRUMENT WAS NOT WORKING PROPERLY. ON ANALYSIS, IT WAS FOUND INSTRUMENT WAS NOT FUNCTIONING PROPERLY. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION ON 10-SEP-2024: THE FAILURE WAS NOT RELATED TO UNINTUITIVE OR UNCONTROLLED MOTION. THERE WAS NO MOVEMENT AT THE INSTRUMENT JAWS. THE ISSUE DID NOT OCCUR WITH THE SURGEON¿S HEAD INSIDE THE SURGEON SIDE CONSOLE¿S (SSC'S) HIGH RESOLUTION STEREO VIEWER (HRSV). THE ISSUE DID NOT OCCUR WHILE THE SURGEON ATTEMPTED TO MANIPULATE INSTRUMENTS FROM THE SSC. THE FAILURE WAS RELATED TO AN INABILITY TO MOVE THE INSTRUMENT AT ALL. THERE WAS NO BROKEN CABLE.
Patient problems: Insufficient Information
MAUDE report 20720107 ↗
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
- 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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