WEREWOLF 72290144Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00885556739624), received between Jul 3, 2020 and Mar 31, 2026 — classified as 2 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Break” (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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 31, 2026Communication or Transmission Problem; Material Deformation; Power Problem

  IT WAS REPORTED THAT DURING A TONSILLECTOMY, THE POWER BUTTON OF ONE (1) WEREWOLF ENT WAS NOT VISIBLE AND HAD FALLEN DEEP INTO THE HOLE. THE MACHINE KEPT POWERING ON AND OFF, AND IT DISPLAYED WARNING SIGNS INDICATING 'SYSTEM COMMUNICATION FAULT'. THE PROCEDURE WAS RESUMED, AFTER A DELAY GREATER THAN 30 MIN, USING THE SAME DEVICE. ADDITIONAL ANESTHESIA WAS NOT REQUIRED AS CONSEQUENCE OF THE SURGICAL PROLONGATION. THE PATIENT'S STATUS IS FINE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24746217 ↗
• MalfunctionDec 30, 2025Electrical /Electronic Property Problem; Protective Measures Problem; Electrical /Electronic Property Problem; Protective Measures Problem

  IT WAS REPORTED THAT, DURING AN ADENOIDECTOMY SURGERY, IT WAS NOTICED THAT THE WEREWOLF CONTROLLER WAS SHOWING A ¿HARDWARE FAULT". SYSTEM WAS NOT WORKING. THE PROCEDURE WAS RESUMED, AFTER A DELAY GREATER THAN 30 MINUTES, USING DIFFERENT SURGICAL TECHNIQUE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23926459 ↗
• MalfunctionMay 15, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING AN ENT PROCEDURE, THE WEREWOLF ENT PRODUCED INTERMITTENT PLASMA ON THE WAND. THE PROCEDURE WAS COMPLETED USING THE SAME DEVICE. THERE WAS A DELAY GREATER THAN 30 MINUTES. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22023952 ↗
• MalfunctionApr 15, 2025Computer Software Problem; Display or Visual Feedback Problem; Computer Software Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT DURING AN ENT PROCEDURE, THE COBLATOR II WAS NOT WORKING, IT WAS FREEZING. A SURGICAL DELAY GREATER THAN 30 MINUTES WAS REPORTED AND A COMPETITOR'S DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21840682 ↗
• MalfunctionNov 27, 2023Arcing; Arcing

  IT WAS REPORTED THAT DURING SET UP, THE WEREWOLF ENT CONTROLLER HAD A SPARK AND WAS FAULTY. A BACK-UP DEVICE WAS AVAILABLE AND NO SURGICAL DELAY WAS REPORTED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18212078 ↗
• MalfunctionApr 17, 2023Power Problem; Power Problem

  IT WAS REPORTED THAT DURING THE SURGERY THE WEREWOLF ENT WAS FROZEN ALL THE TIME, TURN IN AND TURN OFF, BUT THEY DO NOT HAVE BACK UP. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. THERE WAS SIGNIFICANT SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16753290 ↗
• MalfunctionJan 2, 2023Break; Break

  IT WAS REPORTED THAT DURING SET UP FOR A TONSILLECTOMY, THE WEREWOLF ENT HANDLE WAS BROKEN. A COMPETITOR DEVICE WAS AVAILABLE AND A DELAY GREATER THAN 30 MINUTES WAS REPORTED. THE PATIENT WAS ALREADY ANESTHETIZED DURING SUCH DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16082682 ↗
• MalfunctionJun 13, 2022Smoking; Smoking

  IT WAS REPORTED THAT DURING A TURBINATE REDUCTION PROCEDURE, THE ADAPTER OF THE WEREWOLF ENT STARTED SMOKING AND BURNED. IT IS NOT KNOWN IF THE PROBLEM IS THE ADAPTOR OR THE CONSOLE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NON-SIGNIFICANT SURGICAL DELAY USING A BACK-UP DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14682169 ↗
• MalfunctionFeb 18, 2022Break; Break

  IT WAS REPORTED THAT DURING USE IN AN ENT PROCEDURE, THE SALINE PUMP HANDLE ON THE WEREWOLF CONTROLLER BROKE OFF THE CONTROLLER ITSELF. THE PROCEDURE WAS COMPLETED WITH A DELAY GREATER THAN 30 MINS AND WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13559694 ↗
• MalfunctionFeb 14, 2022Break; Break

  IT WAS REPORTED THAT DURING AN ENT PROCEDURE, THE SALINE PUMP HANDLE OF THE WEREWOLF CONTROLLER BROKE OFF. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A SURGICAL DELAY GREATER THAN 30 MINUTES USING A BACK-UP DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13525207 ↗
• MalfunctionJan 3, 2022Smoking; Smoking

  IT WAS REPORTED THAT, THERE WERE SMOKE WHEN THE WEREWOLF ENT WAS USED. SEVERAL WANDS WERE USED WITH THE SAME ISSUE. IT IS UNKNOWN WHETHER THE EVENT HAPPENED DURING SURGERY AND IF THERE WAS A PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13142721 ↗
• InjuryApr 26, 2021Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT DURING SET UP OR INSPECTION WHEN TURNED ON THE WEREWOLF ENT, NO POWER GOES TO THE SCREEN. NO SURGICAL DELAY. THE PROCEDURE WAS COMPLETED WITH A SMITH AND NEPHEW BACK UP OF DIFFERENT TECHNOLOGY(PROCISE MAX). PATIENT INJURIES WERE NOT 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 11725394 ↗
• MalfunctionDec 4, 2020Failure to Power Up; Failure to Power Up

  IT WAS REPORTED THAT THE WEREWOLF DIDN'T 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 10946995 ↗
• InjuryOct 6, 2020Failure to Deliver Energy; Failure to Deliver Energy

  IT WAS REPORTED THAT DURING A SURGERY THE WEREWOLF HAD NO ENERGY COMING TROUGH. THE PROCEDURE WAS COMPLETED WITHOUT DELAY. A COMPETITOR DEVICE WAS USED. NO 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 Information

  MAUDE report 10635485 ↗
• MalfunctionOct 4, 2020Failure to Power Up; Failure to Power Up

  IT WAS REPORTED THAT DURING SETUP THE CONTROLLER WAS NOT TURNING ALL THE WAY ON. THE LIGHT THAT NORMALLY GLOWS GREEN WHILE POWERING ON WAS INSTEAD GLOWING RED. THERE WAS BACKUP DEVICE AVAILABLE AND NO DELAY OR COMPLICATIONS REPORTED. 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 10624674 ↗
• MalfunctionAug 3, 2020Failure to Deliver Energy; Failure to Deliver Energy

  IT WAS REPORTED THAT DURING T&A THE WEREWOLF ENT WAS NOT WORKING; 3 HALO WANDS WERE CONNECTED TO THE UNIT AND SALINE WOULD FLOW OUT OF THE WAND BUT IT WOULD NOT ABLATE OR COAGULATE. A WAND WAS TESTED IN A BOWL OF SALINE AND NO PLASMA SEEMED TO BE FORMING (NO ORANGE GLOW EITHER), TWO MORE WANDS WERE TRIED WITHOUT SUCCESS. THEN, THE WEREWOLF GENERATOR WAS REPLACED WITH ANOTHER WEREWOLF ENT UNIT AND THE NEW HALO WANDS OPENED WORKED AS EXPECTED. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A S+N BACKUP 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 10356774 ↗
• MalfunctionJul 3, 2020Failure to Power Up; Failure to Power Up

  IT WAS REPORTED THE WEREWOLF ENT WON'T 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 10230753 ↗