WEREWOLF ENT ADAPTER 72290136Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00885556699942), received between Apr 12, 2022 and Aug 27, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Smoking” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 27, 2024Electrical Shorting; Electrical Shorting

  IT WAS REPORTED THAT DURING AN INTRACAPSULAR TONSILLECTOMY, WHEN USING A WEREWOLF WAND, THE GENERATOR DISPLAYED THE MESSAGE "WAND SHORT CIRCUIT" AND THE WEREWOLF 8-PIN ADAPTER SEEMED TO HAVE BURNT OUT IN THE PORT. NO OVERHEATING WAS NOTED AS A RESULT OF THE EVENT. THE PROCEDURE WAS COMPLETED WITH A CHANGE IN THE SURGICAL PROCEDURE, BY PERFORMING AN EXTRACAPSULAR TONSILLECTOMY. THERE WAS A SURGICAL DELAY OF LESS THAN 30 MINUTES. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20077559 ↗
• 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 14682223 ↗
• MalfunctionMay 17, 2022Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING A BUGLE REDUCTION, THE WEREWOLF ADAPTER BEGAN TO SMOKE WHEN IT WAS CONNECTED TO THE WEREWOLF CONSOLE AND IT GOT BURNED. THE PROCEDURE WAS COMPLETED WITH A S+N BACK UP DEVICE. THERE WAS NO DAMAGE/ BURN CAUSED TO THE PATIENT. THE PATIENT CURRENT STATUS IS OK. THERE WAS A NON-SIGNIFICANT DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14421338 ↗
• MalfunctionApr 12, 2022Smoking; Smoking

  IT WAS REPORTED THAT DURING USE THE WEREWOLF PIN ADAPTER BEGAN TO SMOKE AND IT BURNED. THE PROCEDURE WAS COMPLETED WITH A S+N BACK UP DEVICE. THERE WAS A NON-SIGNIFICANT DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14090909 ↗