EndoWrist SP 430007Recalls & reported problems
Intuitive Surgical, Inc. · MONOPOLAR CAUTERY INSTRUMENT · Class 2
All models of EndoWrist SP (20)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Intuitive Surgical EndoWrist SP cautery instrument is a robotic surgery tool. Its 148 reports describe tips breaking, cracking, or bending, and parts detaching, and many say the surgery was completed with no injury. The reports include 1 injury and no deaths. Reports fell to 27 in the last 12 months from 62 in the 12 months before. No recalls name this device.
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
- 147
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 147 adverse event reports that list this exact device (DI 00886874114315), received between Sep 18, 2021 and Aug 13, 2026 — classified as 1 injury, 146 malfunctions.
The most frequently reported specific device problem is “Break” (88 reports).
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
- Break88
- Detachment of Device or Device Component21
- Thermal Decomposition of Device8
- Unintended System Motion8
- No Apparent Adverse Event6
- Material Fragmentation5
- Crack4
- Material Split, Cut or Torn3
Patient problems
- No Clinical Signs, Symptoms or Conditions116
- Insufficient Information30
- Foreign Body In Patient1
Recent adverse event reports
The 25 most recent of 147 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 13, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50231285 ↗MalfunctionJun 15, 2026Break; Thermal Decomposition of Device
IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, A SINGLE PORT MONOPOLAR CURVED SCISSORS INSTRUMENT TIP WAS BENT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE CUSTOMER AND OBTAINED THE FOLLOWING INFORMATION: THE DAMAGE DID NOT OCCUR INSIDE THE PATIENT; THEREFORE, NO FRAGMENTS FELL INTO THE PATIENT. THERE HAVE BEEN NO REPORTS OF ANY POST-SURGICAL COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25512103 ↗MalfunctionMay 21, 2026No Device Output
IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED CHOLECYSTECTOMY SURGICAL PROCEDURE, THE 6MM MONOPOLAR CAUTERY INSTRUMENT WOULD NOT RECOGNIZE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CUSTOMER CONFIRMED THAT NO FRAGMENTS FELL INTO THE PATIENT AND THERE WERE NO REPORTS OF FRAGMENTS DETACHING FROM THE DEVICE WHILE USED WITHIN THE PATIENT. NO ACTIONS RELATED TO FRAGMENT RETRIEVAL WERE REQUIRED. NO POST-SURGICAL COMPLICATIONS OR HOSPITAL RETURNS ASSOCIATED WITH RETAINED FOREIGN MATERIAL WERE REPORTED.
Patient problems: Insufficient Information
MAUDE report 25238072 ↗MalfunctionMay 18, 2026Break
IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED RADICAL TONSILLECTOMY SURGICAL PROCEDURE, THERE WAS AN ISSUE AT THE TIP OF A SINGLE PORT MONOPOLAR CURVED SCISSORS INSTRUMENT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25197284 ↗MalfunctionMay 14, 2026Break
IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED HEAD AND NECK SURGICAL PROCEDURE, THE MONOPOLAR CAUTERY INSTRUMENT HAD A CRACKED TIP. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25178119 ↗MalfunctionMay 14, 2026Break
IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE MONOPOLAR CAUTERY INSTRUMENT WOULD NOT HOLD THE TIP. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER HOWEVER THE CUSTOMER WAS UNABLE TO PROVIDE ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25178115 ↗MalfunctionApr 29, 2026Break; Material Split, Cut or Torn
IT WAS REPORTED THAT THE TIP OF A SINGLE PORT MONOPOLAR CAUTERY INSTRUMENT WAS CHIPPED. THE PROCEDURE OUTCOME IS UNKNOWN WITH NO REPORTED INJURY.
Patient problems: Insufficient Information
MAUDE report 25036504 ↗MalfunctionApr 14, 2026Break
REFER TO H11 FOR FOLLOW-UP INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24879009 ↗MalfunctionApr 9, 2026Break
IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE PLASTIC TIP OF THE MONOPOLAR CAUTERY INSTRUMENT SNAPPED OFF. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER HOWEVER THE CUSTOMER WAS UNABLE TO PROVIDE ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24825055 ↗MalfunctionApr 7, 2026Break
IT WAS REPORTED THAT PRIOR TO A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE MONOPOLAR CAUTERY INSTRUMENT WOULD NOT HOLD THE SCISSORS TIP. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE FOLLOWED UP AND CONFIRMED THAT NO FURTHER INFORMATION WAS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24810379 ↗MalfunctionApr 5, 2026Break
IT WAS REPORTED THAT DURING CENTRAL PROCESSING, THE MONOPOLAR CURVED SCISSORS INSTRUMENT HAD A BROKEN TIP. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED.
Patient problems: Insufficient Information
MAUDE report 24786945 ↗MalfunctionMar 19, 2026Break
IT WAS REPORTED THAT THE MONOPOLAR CAUTERY INSTRUMENT HAD A BROKEN TIP. THE CUSTOMER REPORTED EVENT HAS NO REPORT OF PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24644198 ↗MalfunctionMar 19, 2026Break
IT WAS REPORTED THAT PRIOR TO A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE TIP OF THE 6MM MONOPOLAR CAUTERY INSTRUMENT WAS UNABLE TO ATTACH. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24636057 ↗MalfunctionFeb 24, 2026Break
IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, A SINGLE PORT MONOPOLAR CAUTERY INSTRUMENT EXHIBITED NO ENERGY. THE PROCEDURE WAS COMPLETED WITH NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24426270 ↗MalfunctionFeb 18, 2026Break
IT WAS REPORTED THAT THE SINGLE PORT MONOPOLAR CAUTERY INSTRUMENT HAD A BROKEN TIP AND IT COULD NOT BE INSTALLED. THE CUSTOMER REPORTED EVENT HAS NO REPORT OF PATIENT INJURY. INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE CUSTOMER BUT WAS UNABLE TO OBTAIN ANY ADDITIONAL INFORMATION.
Patient problems: Insufficient Information
MAUDE report 24374303 ↗MalfunctionFeb 5, 2026Break
IT WAS REPORTED THAT DURING CENTRAL PROCESSING, THE MONOPOLAR CAUTERY INSTRUMENT HAD A KINK IN THE DISTAL TIP BEFORE THE ARTICULATING SECTION. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24265488 ↗MalfunctionJan 21, 2026Break
IT WAS REPORTED THAT DURING CENTRAL PROCESSING, THE 6MM MONOPOLAR CAUTERY INSTRUMENT HAD A BROKEN TIP. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.
Patient problems: Insufficient Information
MAUDE report 24127605 ↗MalfunctionJan 16, 2026Break
IT WAS REPORTED THAT PRIOR TO A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE TIP OF THE 6MM MONOPOLAR CAUTERY INSTRUMENT WAS BROKEN WHERE THE SPATULA OR HOOK WOULD CONNECT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24101952 ↗MalfunctionJan 14, 2026Break
IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE MONOPOLAR CAUTERY INSTRUMENT WAS MISSING THE TIP. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24064746 ↗MalfunctionJan 8, 2026Break
IT WAS REPORTED THAT DURING CENTRAL PROCESSING, THE SINGLE-PORT (SP) MONOPOLAR CAUTERY INSTRUMENT HAD A BROKEN TIP. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.
Patient problems: Insufficient Information
MAUDE report 24014540 ↗MalfunctionJan 6, 2026Break
IT WAS REPORTED THAT PRIOR TO START OF A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE 6MM MONOPOLAR CAUTERY INSTRUMENT WAS OBSERVED TO HAVE AN INCOMPLETE TIP. THE PROCEDURE WAS ABORTED DUE TO PATIENT HAVING TOO MUCH PERINEPHRIC FAT MAKING IT DIFFICULT TO IDENTIFY THE CRITICAL STRUCTURES NECESSARY FOR PROCEDURE COMPLETION AND IT WAS BEING REFERRED TO A HIGHER LEVEL OF CARE. INTUITIVE SURGICAL INC., (ISI) FOLLOWED UP WITH THE ROBOTIC COORDINATOR AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: NO FRAGMENTS WERE REPORTED TO HAVE FALLEN FROM THE INSTRUMENT WHILE IN USE DURING THE LAST PROCEDURE. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO EXPERIENCING ANY POST-SURGICAL COMPLICATIONS RELATED TO RETENTION OF FOREIGN MATERIAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23985324 ↗MalfunctionDec 29, 2025Unintended System Motion; Unintended System Motion
REFER TO H11 FOR FOLLOW-UP INFORMATION.
Patient problems: Insufficient Information
MAUDE report 23909215 ↗MalfunctionDec 3, 2025Break; Break
REFER TO H11 FOR FOLLOW-UP INFORMATION.
Patient problems: Insufficient Information
MAUDE report 23701732 ↗MalfunctionDec 2, 2025Break; Break
IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE MONOPOLAR CURVED SCISSORS INSTRUMENT TIP WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23698610 ↗MalfunctionNov 25, 2025Break; Break
REFER TO H11 FOR FOLLOW-UP INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23650742 ↗
Other System, surgical, computer controlled instrument devices
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- 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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