VULCAN 7210812FRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 03596010613561), received between Feb 26, 2019 and Dec 27, 2022 — classified as 1 injury, 9 malfunctions.

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

• 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 ↗
• MalfunctionApr 20, 2021Failure to Deliver Energy; Material Deformation; Failure to Deliver Energy; Material Deformation

  IT WAS REPORTED THAT THE VULCAN GENERATOR WAS NOT WORKING. THIS WAS NOTICED DURING INSPECTION; THEREFORE, NO PATIENT WAS INVOLVED. RESULTS OF INVESTIGATION HAVE CONCLUDED THAT THIS UNIT DID NOT HAVE RF OUTPUT 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 11694080 ↗
• MalfunctionMar 28, 2021Calibration Problem; Protective Measures Problem; Calibration Problem; Protective Measures Problem

  IT WAS REPORTED THAT, DURING A WRIST ARTHROSCOPY USING A "VULCAN GENERATOR"; THE USER SAID THAT THEY WERE GETTING THE VOLTAGE CALIBRATION FAIL ALARM. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURIES OR OTHER 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 11580381 ↗
• MalfunctionFeb 22, 2021Failure to Deliver Energy; Failure to Deliver Energy

  IT WAS REPORTED THAT, DURING A HIP SCOPE, THE VULCAN GENERATOR WOULDN'T SEND POWER TO THE WAND. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING THE SAME DEVICE. NO PATIENT INJURY OR OTHER 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 11359249 ↗
• MalfunctionNov 9, 2020Protective Measures Problem; Protective Measures Problem

  IT WAS REPORTED THAT DURING SURGERY, THE VULCAN GENERATOR HAD A VOLTAGE CAL FAILURE ERROR AFTER IT WAS ON FOR A PERIOD OF TIME. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER 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 Known Impact Or Consequence To Patient

  MAUDE report 10813942 ↗
• InjurySep 18, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING A PROCEDURE, THE GENERATOR WAS FAULTING AND THAT THE ATTACHED FOOT PEDAL HAD A DAMAGED CABLE, NO MORE INFORMATION. THERE WAS NO DELAY AND THE PROCEDURE WAS COMPLETED WITH A COMPETITOR DEVICE.

  Patient problems: No Information

  MAUDE report 10556805 ↗
• MalfunctionAug 24, 2020Noise, Audible; Intermittent Loss of Power; Noise, Audible; Intermittent Loss of Power

  IT WAS REPORTED THAT DURING A HIP ARTHROSCOPY, THE VULCAN GENERATOR WAS MAKING A LOUD BEEPING NOISE AND SOMETIMES IT WOULD SHUT OFF. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER 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 Known Impact Or Consequence To Patient

  MAUDE report 10446404 ↗
• MalfunctionDec 10, 2019Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE GENERATOR WAS OVERHEATING. BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE. NO DELAY AND NO PATIENT INJURIES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9447403 ↗
• MalfunctionMay 7, 2019Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THAT DURING A HIP ARTHROSCOPY THE GENERATOR WAS NOT WORKING. NO BACK UP DEVICE WAS AVAILABLE, NO DELAY NOR PATIENT INJURIES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8586491 ↗
• MalfunctionFeb 26, 2019Electrical Shorting

  IT WAS REPORTED THAT DURING A ROTATOR ARTHROSCOPY, THE DEVICE SHORTED OUT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8372516 ↗