None 470384Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00886874112601), received between May 27, 2023 and Sep 17, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Thermal Decomposition of Device” (4 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.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2026Thermal Decomposition of Device; Melted

  It was reported that during a da Vinci-assisted surgical procedure, the "code" on the Bipolar energy cable had melted. The procedure was completing as planned with no reported injury.Intuitive Surgical, Inc. (ISI) followed up with the initial reporter and obtained the following additional information: The customer reported no sparking, smoke, fire, or thermal damage. The cable was inspected prior to the event with no damage noted, and the number of prior uses and how long it had been on site were both unknown. At the time, the cable was connected to an Integrated Electro Surgical Unit (IESU) generator using bipolar energy and was plugged into Maryland and Fenestrated Bipolar instruments; no information was provided on whether it was connected to the correct generator port or whether a third-party generator was in use. There were no injuries, the issue was resolved by switching to a backup cable.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50811422 ↗
• MalfunctionJun 16, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT DURING DA VINCI-ASSISTED SURGICAL PROCEDURE, THE BIPOLAR ENERGY CORD WAS NOT WORKING. THE PROCEDURE WAS ABORTED/CONVERTED DUE TO ANATOMY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25521467 ↗
• MalfunctionApr 29, 2026Thermal Decomposition of Device

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE BIPOLAR 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 25035629 ↗
• MalfunctionJan 27, 2026Thermal Decomposition of Device

  IT WAS REPORTED THAT THE BIPOLAR ENERGY CABLE HAD A POOR CONNECTION AND SHOWED SIGNS OF BURNING AT THE CONNECTION SITE. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24192968 ↗
• MalfunctionJan 23, 2026Thermal Decomposition of Device

  IT WAS REPORTED THAT THE BIPOLAR ENERGY CABLE HAD POOR CONNECTION AND BURNED IN CONNECTION. THE CUSTOMER REPORTED EVENT HAS NO REPORT OF PATIENT INJURY.

  Patient problems: Insufficient Information

  MAUDE report 24166280 ↗
• MalfunctionMay 27, 2023No Device Output; No Device Output

  IT WAS REPORTED THAT DURING A VINCI-ASSISTED SURGICAL PROCEDURE, WHEN THE MONOPOLAR CURVED SCISSORS AND MARYLAND BIPOLAR FORCEPS INSTRUMENTS WERE INTRODUCED, AND THE MONOPOLAR AND BIPOLAR CABLES WERE CONNECTED, NO ENERGY WAS PASSED TO THE INSTRUMENTS. THE CABLES WERE REPLACED; HOWEVER, THE ISSUE PERSISTED. THE SURGEON MADE THE DECISION TO CONVERT THE PROCEDURE TO LAPAROSCOPIC SURGERY WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: UPON ENCOUNTERING THE ENERGY ISSUE, THE CUSTOMER RE-STARTED THE ERBE, CHECKED THE CABLES, AND EXCHANGED TO ANOTHER PAIR OF ACTIVATION CABLES; HOWEVER, THE ENERGY CONNECTION REMAINED UNSUCCESSFUL. AN ISI FIELD SERVICE ENGINEER (FSE) DURING A MAINTENANCE VISIT HAD ADVISED THE CUSTOMER TO ACQUIRE NEW ACTIVATION CABLES. A VISUAL INSPECTION WAS PERFORMED, AND DAMAGE WAS NOTED ON ONE CABLE. NO PATIENT HARM OR INJURY WAS REPORTED. THE SURGEON UNDOCKED FROM THE DA VINCI SYSTEM AND CONTINUED THE PROCEDURE LAPAROSCOPICALLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17015837 ↗