da Vinci Energy 378848Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00886874116982), received between Apr 26, 2024 and Jun 25, 2024 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Energy Output Problem” (2 reports).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. Jun 22, 2022Class IICompleted

   Due to preventative maintenance (PM) not being performed on E-100 generators which is a bipolar electrosugical unit designed to be used with the da Vinci Xi and X systems.

   Z-1484-2022 · Root cause: Process design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 25, 2024Energy Output Problem; Energy Output Problem

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE E-100 GENERATOR DID NOT WORK. THE LED ON POWER BUTTON WAS ON, BUT IT WAS NOT WHILE THE INSTRUMENT WAS CONNECTED. THE CUSTOMER STATED THAT THEY USED THE ERBE GENERATOR WITH THE VESSEL SEALER INSTRUMENT WITHOUT ANY PROBLEM. AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SERVICE ENGINEER (TSE) VIEWED THE SYSTEM EVENT LOGS BUT DID NOT NOTICE ANYTHING RELEVANT. 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 E-100 WAS NOT WORKING AT ALL. IT WAS A NEW DA VINCI SYSTEM INSTALLED. THE CUSTOMER USED THE ERBE GENERATOR AND WERE ABLE TO USE THE VESSEL SEALER WITHOUT ANY PROBLEMS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19610574 ↗
• MalfunctionMay 9, 2024Output Problem; Output Problem

  IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE E-100 GENERATOR FAILED TO FIRE INTERMITTENTLY. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING INFORMATION: THE CUSTOMER WAS UNABLE TO PROVIDE ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19281326 ↗
• InjuryApr 26, 2024Energy Output Problem; Energy Output Problem

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED GASTRIC BYPASS (ROUX-EN-Y) SURGICAL PROCEDURE, THE CUSTOMER REPORTED AN ISSUE WITH THE VESSEL SEALER EXTEND (VSE). THE VSE FAILED AND RESULTED IN AN ABORT TO OPEN. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) REVIEWED THE LOGS BUT FOUND NO RELATED ISSUE. THE CUSTOMER HAD NO ADDITIONAL DETAILS ABOUT THE ISSUE AS FAR AS THE ARM IT WAS INSTALLED IN, WHETHER THE VSE WAS USED IN THE E100/IESU, OR HOW EXACTLY THE VSE FAILED BUT THE CUSTOMER HAS INDICATED SOMETHING WAS WRONG AND WAS NOT GOING TO PERFORM SURGERY WITHOUT THE SYSTEM BEING CHECKED. THE PROCEDURE WAS CONVERTED TO OPEN SURGERY.

  Patient problems: Insufficient Information

  MAUDE report 19191815 ↗