Vulcan 7209692Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 03596010470546), received between Oct 21, 2019 and Dec 7, 2022 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (3 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionMar 16, 2021Activation Failure; Activation Failure

  IT WAS REPORTED THAT FOOTSWITCH,VULCAN DID NOT WORK. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. RESULTS OF INVESTIGATION HAVE CONCLUDED THAT THE DEVICE DID NOT FUNCTION WHEN ACTIVATED, 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 11496488 ↗
• MalfunctionMar 15, 2021No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT THE VULCAN FOOTSWITCH WAS NOT WORKING. 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 11486117 ↗
• MalfunctionJul 29, 2020Failure to Power Up; Failure to Power Up

  IT WAS REPORTED THAT THE FOOTSWITCH WAS NOT ACTIVATING. IT IS UNKNOWN WHETHER THE EVENT HAPPENED DURING SURGERY AND IF THERE WAS A PATIENT INVOLVEMENT. THE UNKNOWN PROCEDURE WAS COMPLETED USING A BACK UP DEVICE AND NO DELAYS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 10340702 ↗
• MalfunctionJan 30, 2020Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT, DURING A HIP ARTHROSCOPY, THE VULCAN FOOTSWITCH OFTEN STICKS. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THE SURGERY WAS DELAYED FOR MORE THAN 30 MIN. THE PATIENT WAS NOT HARMED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9649063 ↗
• MalfunctionOct 23, 2019Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE DEVICE CORD WAS BURNED, IT FELL OFF. IT WAS FOUND BEFORE A PROCEDURE THEREFORE NO PATIENT WAS INVOLVED. 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 9224509 ↗
• MalfunctionOct 21, 2019Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE CORD OF THE FOOTSWITCH WAS BURNED AND FELL OFF. THIS WAS NOTICED BEFORE THE PROCEDURE; THEREFORE, NO PATIENT WAS INVOLVED. 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 9216688 ↗