COBLATION 72290105SRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00885556645352), received between Apr 22, 2019 and Feb 8, 2026 — classified as 1 injury, 10 malfunctions.

The most frequently reported specific device problem is “Failure to Power Up” (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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 8, 2026Device Alarm System; Display or Visual Feedback Problem

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, AFTER THE WEREWOLF CONTROLLER WAS TURNED ON, THE SCREEN GOT DARK, AND AN ALARM SOUNDED. THE SURGERY WAS INTERRUPTED AND WAS SCHEDULED FOR ANOTHER DAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24288347 ↗
• MalfunctionMar 25, 2024Electrical Shorting; Electrical Shorting

  IT WAS REPORTED THAT DURING AN ACL RECONSTRUCTION THE NURSE DID NOT CLAMP THE WATER BEFORE CHANGING THE BAGS OF FLUID HANGING ABOVE THE WEREWOLF CONTROLLER. WATER WAS POURED DIRECTLY INTO THE BACK OF THE DEVICE CAUSING THE BOX TO SPARK OUT THE BACK AND COMPLETELY FRY. THE PROCEDURE WAS COMPLETED USING A BACK-UP DEVICE. THERE WAS NO SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18969690 ↗
• MalfunctionFeb 11, 2021Failure to Power Up; Failure to Power Up

  IT WAS REPORTED THAT THE GENERATOR WILL NOT TURN ON. NO CASE INVOLVED. THEREFORE, 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 11319753 ↗
• InjuryDec 16, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT WEREWOLF CONTROLLER'S POWER BUTTON CAME APART FROM CONSOLE AND PUSHED INSIDE THE MACHINE, DURING SET UP OR INSPECTION FOR AN UNKNOWN PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A COMPETITOR'S DEVICE. NO PATIENT INJURY OR DELAYS 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 11018756 ↗
• MalfunctionDec 9, 2020Electrical Shorting; Electrical Shorting

  IT WAS REPORTED THAT THE, BEFORE A SHOULDER PROCEDURE, THE WEREWOLF CONTROLLER HAD A SMOKING SMELL COMING FROM IT. NO PATIENT INVOLVEMENT REPORTED. RESULTS OF INVESTIGATION REVEALED THE UNIT THE DOES NOT TURN ON 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 10976938 ↗
• MalfunctionNov 22, 2020Connection Problem; Connection Problem

  IT WAS REPORTED THAT THE WEREWOLF CONTROLLER HAD AN ERROR AFTER IT WAS REBOOTED AND THE HANDPIECE WAS NOT DETECTED. 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 10881673 ↗
• MalfunctionNov 13, 2020Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THE WEREWOLF CONTROLLER COULD NOT READ THE HAND PIECE. 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 10835377 ↗
• MalfunctionOct 15, 2020Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THE WEREWOLF CONTROLLER WAS NOT RECOGNIZING THE WANDS. 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 10681986 ↗
• MalfunctionSep 9, 2020Failure to Power Up; Failure to Power Up

  IT WAS REPORTED THAT, THE "WEREWOLF CONTROLLER" 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 Patient Involvement

  MAUDE report 10511303 ↗
• MalfunctionJul 29, 2020Failure to Power Up; Failure to Power Up

  IT WAS REPORTED THAT THE CONTROLLER DOES NOT TURN ON. NO CASE INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 10341606 ↗
• MalfunctionApr 22, 2019Device Emits Odor; Sparking

  IT WAS REPORTED THAT THE DEVICE SMELLS LIKE IT IS BURNING AND THERE WAS SPARKING ON THE SCREEN. INCIDENT OCCURRED BEFORE THE PROCEDURE; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8537772 ↗