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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

Nov 2023: 1 reportsDec 2023: 0 reportsJan 2024: 1 reportsFeb 2024: 1 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 1 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 1 reportsAug 2025: 0 reportsSep 2025: 1 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 1 reportsMay 2026: 1 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

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

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