VULCANRecalls & reported problems across all models

We found 6 models of VULCAN by Smith & Nephew, Inc. in the FDA's device registry (GUDID). Together they are named in 108 adverse event reports in the FDA's MAUDE database, received between Dec 28, 2017 and May 29, 2023 — classified as 7 injuries, 101 malfunctions.

The most frequently reported specific device problem is “Protective Measures Problem” (17 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported VULCAN problems

VULCAN models

6 models, most reported first. Each model has its own page with its reports, recalls and device details.

• VULCAN 7210812

  ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
  50 reports
• VULCAN 7210812S

  ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
  31 reports
• Vulcan 7209692

  Electrosurgical, cutting & coagulation & accessories
  10 reports
• VULCAN 7210812F

  ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
  10 reports
• VULCAN 7210812S3E

  ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
  5 reports
• VULCAN 7210812SR

  Electrosurgical, cutting & coagulation & accessories
  2 reports

Recent VULCAN adverse event reports

The 15 most recent reports across all models, 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 27, 2022Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE VULCAN GENERATOR DISPLAYED A TEMPERATURE WARNING AND WAS OVERHEATING. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16056744 ↗
• MalfunctionDec 7, 2022Electrical Shorting; Reset Problem; Intermittent Energy Output; Electrical Shorting; Reset Problem; Intermittent Energy Output

  IT WAS REPORTED THAT DURING AN ACL, A FOOTSWITCH VULCAN, WAS GIVING A SHORTING OUT AND RESETTING ISSUES. SURGERY RESUMED AFTER A DELAY GREATER THAN 30 MINUTES WITH THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15936712 ↗
• MalfunctionJun 27, 2022Overheating of Device; Unexpected Shutdown; Overheating of Device; Unexpected Shutdown

  IT WAS REPORTED THAT DURING THE SET UP FOR AN UNKNOWN PROCEDURE, THE CORD WIRE OF A VULCAN FOOTSWITCH WARMED UP AND THEN THE DEVICE STOPPED WORKING. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14830631 ↗
• 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 ↗
• MalfunctionOct 4, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING SET UP OR INSPECTION, THE PEDALS OF THE FOOTSWITCH VULCAN WERE STICKING AND MADE THE UNIT TO RUN CONTINUOUSLY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A SMITH AND NEPHEW BACK UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12568890 ↗
• 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 29, 2021Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT THE VULCAN GENERATOR HAD VOLTAGE CALIBRATION FAIL. NO CASE REPORTED; THEREFORE, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11905738 ↗
• MalfunctionMay 29, 2021Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT THE VOLTAGE CALIBRATION OF THE VULCAN GENERATOR FAILED. NO CASE REPORTED; THEREFORE, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11905737 ↗
• 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 ↗
• MalfunctionMay 14, 2021No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT THE VULCAN FOOTSWITCH WAS NOT WORKING. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11826416 ↗
• MalfunctionApr 28, 2021Failure to Power Up; Failure to Power Up

  IT WAS REPORTED THAT THE VULCAN GENERATOR HAD THE POWER SUPPLY BROKE DOWN. NO CASE INVOLVED; 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 11735999 ↗
• MalfunctionApr 21, 2021Unexpected Shutdown; Unexpected Shutdown

  IT WAS REPORTED THAT THE WEREWOLF CONTROLLER WAS REBOOTING. 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 11703702 ↗

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