VULCAN 7210812Recalls & reported problems

Summary

The FDA's MAUDE database contains 50 adverse event reports that list this exact device (DI 03596010519399), received between Feb 13, 2018 and May 29, 2023 — classified as 5 injuries, 45 malfunctions.

The most frequently reported specific device problem is “Protective Measures Problem” (8 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 25 most recent of 50 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 29, 2023Unintended Power Up; Unintended Power Up

  IT WAS REPORTED, DURING USE, THE PEDAL OF THE VULCAN GENERATOR COULD NOT REBOUND AND REMAINED IN AN ELECTRIC COAGULATION STATE, MAKING IT IMPOSSIBLE TO USE. IT IS UNKNOWN WHETHER THE EVENT HAPPENED DURING SURGERY, IF THERE WAS PATIENT INVOLVEMENT, IF THERE WAS A BACK-UP DEVICE AVAILABLE OR IF THERE WAS A DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17017283 ↗
• MalfunctionMar 29, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT, DURING A SHOULDER ARTHROSCOPY, THE VULCAN GENERATOR WAS NOT WORKING AS IT WOULD NOT TRANSITION INTO BIPOLAR MODE, LEAVING THE UNIT IN MONOPOLAR AND THE ELECTRO BONE RESECTOR DEVICE INOPERABLE. THE PROCEDURE WAS COMPLETED WITH A DELAY GREATER THAN 30 MINUTES USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16637292 ↗
• MalfunctionDec 29, 2021Communication or Transmission Problem; Protective Measures Problem; Communication or Transmission Problem; Protective Measures Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE VULCAN GENERATOR WAS SHOWING AN ALARM AND DID NOT CONNECT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A BACK-UP DEVICE, A DELAY GREATER THAN 30 MINS WAS REPORTED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13109318 ↗
• MalfunctionAug 26, 2021Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE VULCAN GENERATOR WAS HOT. IT IS UNKNOWN WHETHER THE EVENT HAPPENED DURING SURGERY AND IF THERE WAS PATIENT INVOLVEMENT. IT IS UNKNOWN IF THERE WAS A DELAY. THE PROCEDURE WAS COMPLETED WITH A BACKUP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12370975 ↗
• MalfunctionJun 6, 2021Protective Measures Problem; Noise, Audible; Protective Measures Problem; Noise, Audible

  IT WAS REPORTED THAT DURING A HIP ARTHROSCOPY, WHEN THE VULCAN GENERATOR WAS TURNED ON, A LOUD ALARM NOISE OCCURRED AND A VOLTAGE CAL FAILURE ERROR WAS DISPLAYED. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11944591 ↗
• MalfunctionMay 14, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT THE VULCAN GENERATOR DID NOT RECOGNIZE THE RETURN ELECTRODE. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11828712 ↗
• MalfunctionApr 8, 2021Activation Problem; Activation Problem

  IT WAS REPORTED THAT WHEN THE VULCAN GENERATOR GROUNDING PEDAL IS BEING HIT, A RED LIGHT APPEARED AND NOTHING HAPPEN. NO CASE WAS INVOLVED. 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 11633388 ↗
• MalfunctionApr 5, 2021Unexpected Shutdown; Unexpected Shutdown

  IT WAS REPORTED THAT THE VULCAN GENERATOR WOULD SHUT OFF AFTER SO MANY SECONDS WORKING WITH THE WAND, THEN IT REBOOT. 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 11614256 ↗
• InjuryMar 24, 2021Failure to Deliver Energy; Failure to Deliver Energy

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE COBLATION FUNCTION WOULD NOT WORK IN THE VULCAN GENERATOR CE MARK. THE PROCEDURE WAS COMPLETED WITH A CHANGE IN SURGICAL TECHNIQUE. NO DELAY OR PATIENT COMPLICATIONS WERE REPORTED. 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 11565796 ↗
• MalfunctionMar 18, 2021Unexpected Shutdown; Unexpected Shutdown

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE USING THE VULCAN GENERATOR CE MARK, THE SYSTEM GOT RESTARTED WHEN ABLATION SWITCH WAS PRESSED. THERE WAS A DELAY GREATER THAN 30 MINUTES. THE PROCEDURE WAS FINISHED WITH THE SAME DEVICE. NO INJURIES OR OTHER COMPLICATION WERE REPORTED. 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 11520486 ↗
• MalfunctionFeb 26, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING SETUP FOR A HIP ARTHROSCOPY THE GENERATOR WAS NOT READING THE GROUNDING PAD AND ALARMS WHEN FOOT PEDAL WAS PRESSED. THERE WAS BACKUP DEVICE AVAILABLE AND NO DELAY OR COMPLICATIONS REPORTED. 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 11387845 ↗
• MalfunctionFeb 21, 2021Device Alarm System; Device Alarm System

  IT WAS REPORTED THAT THE VULCAN GENERATOR, CE MARK KEPT ALARMING WHEN TURNED ON THE POWER. THERE WAS NO PATIENT INVOLVED. 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 11356725 ↗
• MalfunctionFeb 15, 2021Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT, DURING SET UP FOR SURGERY, THE "VULCAN GENERATOR" WAS NOT REGISTERING THE GROUNDING PAD. THERE WAS NO DELAY AND 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 11330073 ↗
• MalfunctionFeb 15, 2021Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT, DURING SET UP FOR SURGERY, THE "VULCAN GENERATOR" WAS NOT REGISTERING THE GROUNDING PAD. THE INCIDENT OCCURRED BEFORE THE PROCEDURE; 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 11330058 ↗
• MalfunctionFeb 1, 2021Failure to Power Up; Failure to Power Up

  IT WAS REPORTED THAT THE GENERATOR HAS NO OUTPUT. NO CASE INVOLVED. 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 11261838 ↗
• MalfunctionJan 21, 2021Break; Communication or Transmission Problem; Break; Communication or Transmission Problem

  IT WAS REPORTED THAT THE VULCAN GENERATION HAD THE CONNECTOR PIN BROKEN SO IT DID NOT DETECT THE PROBE. 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 11206289 ↗
• MalfunctionJan 7, 2021Calibration Problem; Protective Measures Problem; Calibration Problem; Protective Measures Problem

  IT WAS REPORTED THAT THE VULCAN GENERATOR WAS DISPLAYING A "VOLTAGE CALIBRATION FAILURE" MESSAGE AND ALARM WHEN PLUGGED IN. THE DEVICE WAS UNPLUGGED AND THEN PLUGGED BACK IN A MINUTE LATER. AFTER SEVERAL MINUTES THE MESSAGE AND ALARM REAPPEARED. INCIDENT OCCURRED BEFORE A HIP ARTHROSCOPY. THERE WAS NO DELAY AND A BACK-UP DEVICE WAS AVAILABLE. 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 11131559 ↗
• MalfunctionJan 7, 2021Failure to Power Up; Failure to Power Up

  IT WAS REPORTED THAT THE VULCAN GENERATOR COULD NOT STAY TURNED ON. 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 11131503 ↗
• MalfunctionJan 7, 2021Failure to Power Up; Failure to Power Up

  IT WAS REPORTED THAT THE VULCAN GENERATOR WAS NOT TURNING ON. THIS WAS NOTICED DURING SET UP THE PROCEDURE; THEREFORE, NO PATIENT WAS INVOLVED. A BACKUP DEVICE WAS AVAILABLE AND NO DELAY WAS REPORTED. 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 11131390 ↗
• MalfunctionJan 7, 2021Protective Measures Problem; Protective Measures Problem

  IT WAS REPORTED THAT DURING THE SET UP BEFORE A HIP ARTHROSCOPY SURGERY THE VULCAN GENERATOR DISPLAYED A MESSAGE ¿VOLTAGE CALIBRATION FAILURE¿ AND ALARM WHEN IT WAS PLUGGED IN. THE VULCAN WAS UNPLUGGED AND THEN PLUGGED BACK IN A MINUTE LATER, AFTER SEVERAL MINUTES THE MESSAGE AND THE ALARM REAPPEARED. NO PATIENT INJURIES OR DELAY REPORTED. SMITH AND NEPHEW BACK-UP DEVICE WAS AVAILABLE TO COMPLETE THE SURGERY. 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 11130734 ↗
• MalfunctionDec 28, 2020No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING THE SET UP INSPECTION, THE VULCAN GENERATOR WAS NOT WORKING WITH THE GROUNDING PAD. BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE. NO DELAY AND NO PATIENT INJURIES WERE REPORTED. 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 11078151 ↗
• MalfunctionDec 22, 2020Connection Problem; Connection Problem

  IT WAS REPORTED THAT THE VULCAN GENERATOR PAD WAS NOT RECOGNIZING. 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 11057139 ↗
• MalfunctionDec 18, 2020Failure to Power Up; Failure to Power Up

  IT WAS REPORTED THAT THE VULCAN GENERATOR WOULD NOT TURN ON. 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 11036600 ↗
• InjuryNov 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER THE PROCEDURE THERE WAS A BURN ON THE PATIENT AT THE SITE OF THE GROUNDING PAD. GROUNDING PAD WAS CONNECTED ON THE NON OPERATIVE SIDE OF THE PATIENT AT THE TORSO LEVEL. THE PATIENT SUFFERED 2ND AND 3RD DEGREE BURNS WHICH REQUIRED TO BE TREATED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Burn(s)

  MAUDE report 10865691 ↗
• MalfunctionNov 17, 2020Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT THE VULCAN GENERATOR HAD A VOLTAGE CALIBRATION FAILURE ERROR. 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 Patient Involvement

  MAUDE report 10854477 ↗