None 470383Recalls & reported problems
Intuitive Surgical, Inc. · MONOPOLAR CAUTERY CORD · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00886874112595), received between Nov 16, 2023 and May 11, 2026 — classified as 8 malfunctions.
The most frequently reported specific device problem is “Thermal Decomposition of Device” (5 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Thermal Decomposition of Device5
- Material Split, Cut or Torn2
- Sparking2
- Break1
- Energy Output Problem1
- Smoking1
Patient problems
- No Clinical Signs, Symptoms or Conditions8
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 11, 2026Energy Output Problem
IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE THAT THE MONOPOLAR ENERGY CABLE WAS NOT PROVIDING ANY ENERGY. THE CASE WAS REPORTEDLY ABORTED WITH NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25143830 ↗MalfunctionApr 22, 2026Sparking
IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE MONOPOLAR ENERGY CABLE WAS INVOLVED IN A SPARKING INCIDENT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24961263 ↗MalfunctionSep 17, 2025Thermal Decomposition of Device; Thermal Decomposition of Device
IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE HIGH FREQUENCY MONOPOLAR INSTRUMENT CABLE END CAUGHT FIRE, CAUSING THE CABLE TO BURN OUT. THE CABLE WAS REMOVED AND REPLACED WITH A BACKUP. FOLLOWING THIS, THE USER CONTINUED AND COMPLETED THE PROCEDURE WITH NO FURTHER ISSUES. NO FRAGMENT FELL INTO THE PATIENT. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23078946 ↗MalfunctionJul 30, 2025Thermal Decomposition of Device; Material Split, Cut or Torn; Thermal Decomposition of Device; Material Split, Cut or Torn
REFER TO H11 FOR FOLLOW-UP INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22670348 ↗MalfunctionJul 8, 2024Thermal Decomposition of Device; Sparking; Thermal Decomposition of Device; Sparking
REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19692449 ↗MalfunctionFeb 2, 2024Thermal Decomposition of Device; Material Split, Cut or Torn; Thermal Decomposition of Device; Material Split, Cut or Torn
REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18636108 ↗MalfunctionJan 3, 2024Thermal Decomposition of Device; Smoking; Thermal Decomposition of Device; Smoking
REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18440043 ↗MalfunctionNov 16, 2023Break; Break
IT WAS REPORTED THAT DURING CENTRAL PROCESSING THE CABLE MONOPOLAR ENERGY THAT HAD A MISSING PRONG ON CORD. THERE WAS NO REPORT OF PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18146216 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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