VULCAN 7210812SRRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556586341), received between Dec 5, 2018 and Apr 21, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Power Problem” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• MalfunctionDec 5, 2018Power Problem

  IT WAS REPORTED THAT THE POWER CUTS DURING OPERATION. THERE WAS NO BACKUP DEVICE AVAILABLE AND NO DELAY OR PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8135558 ↗