VULCAN 7210812S3ERecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00885554031225), received between Dec 28, 2017 and Mar 16, 2021 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 16, 2021Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THE IMPEDANCE IN THE VULCAN GENERATOR WAS FAULTING. NO CASE INVOLVED. RESULTS OF INVESTIGATION HAVE CONCLUDED THAT THIS UNIT DOES NOT RECOGNIZE RETURN GROUND WHICH MAKES IT A REPORTABLE EVENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11498932 ↗
• InjuryJan 5, 2021Protective Measures Problem; Noise, Audible; Protective Measures Problem; Noise, Audible

  IT WAS REPORTED THAT THE VULCAN GENERATOR WAS MAKING A CONTINUOUS LOUD BEEP, HAD THE FAULT LIGHT LIT, AND HAD BOXES ACROSS THE DISPLAY SCREEN. INCIDENT OCCURRED BEFORE THE PROCEDURE. THERE WAS NO DELAY AND THE PROCEDURE HAD TO BE COMPLETED WITH A MULTIVAC WAND. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11116607 ↗
• MalfunctionDec 11, 2020Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THE VULCAN GENERATOR COULD NOT RECOGNIZE THE RETURN ELECTRODE. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10992416 ↗
• MalfunctionMar 20, 2018Device Displays Incorrect Message; Device Operates Differently Than Expected

  IT WAS REPORTED THAT THE SURGEON WAS PERFORMING A SUBACROMIAL DECOMPRESSION USING AN ELECTROBLADE AND VULCAN RF UNIT. THEN HE WENT TO USE THE CAUTERY FEATURE AND NOTHING HAPPENED. NO ERROR MESSAGE. HE CHECKED THE CONNECTIONS TO THE VULCAN AND ALL WERE PLUGGED IN CORRECTLY, HE CHANGED THE ELECTROBLADE AND IT DID NOT CAUTERIZE AS WELL. AN ERROR MESSAGE APPEARED ON THE VULCAN SAYING UNABLE TO DETERMINE VOLTAGE SERVICE REQUIRED. THERE WAS NO BACKUP DEVICE AVAILABLE AND NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7355927 ↗
• MalfunctionDec 28, 2017Electrical /Electronic Property Problem; Loss of Power

  IT WAS REPORTED THAT VULCAN GENERATOR IS NOT WORKING, SHORTED OUT OCCURRED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7152916 ↗