WEREWOLFRecalls & reported problems across all models

We found 2 models of WEREWOLF by Smith & Nephew, Inc. in the FDA's device registry (GUDID). Together they are named in 39 adverse event reports in the FDA's MAUDE database, received between Jul 3, 2020 and Apr 8, 2026 — classified as 3 injuries, 36 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (8 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported WEREWOLF problems

WEREWOLF models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• WEREWOLF+ 72290146

  Electrosurgical, cutting & coagulation & accessories
  22 reports
• WEREWOLF 72290144

  Electrosurgical, cutting & coagulation & accessories
  17 reports

Recent WEREWOLF adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionApr 8, 2026Unintended Power Up; Self-Activation or Keying

  IT WAS REPORTED THAT, DURING A HIP REPLACEMENT, ONE (1) WEREWOLF 20000 CONTROLLER WAS FIRING OFF RANDOMLY, IT WOULD ACTIVATE BY ITSELF WITHOUT ANYONE TOUCHING THE TRIGGER. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A SIMILAR S+N BACK-UP PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24817051 ↗
• 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 ↗
• MalfunctionMar 5, 2026Unintended Power Up; Audible Prompt/Feedback Problem

  IT WAS REPORTED THAT DURING A BILATERAL INFERIOR TURBINATE REDUCTION, THERE WAS AN INCIDENT WITH THE WEREWOLF CONTROLLER. THE SURGEON WAS USING AN ARIS WAND AND WHEN THE SURGEON COMPLETED THE PROCEDURE, THE WAND WAS REMOVED FROM THE PATIENT¿S NOSE, BUT THE IRRIGATION PUMP STARTED CYCLING AND SPRAYED FLUID INTO THE SURGEON¿S FACE. THE LIGHTS IN THE ROOM WERE OFF; SHE WAS USING THE CAMERA AND VIDEO EQUIPMENT TO DO THE CASE. AS SOON AS SHE NOTIFIED THE CIRCULATOR THAT SHE HAD FLUID IN HER FACE, THE CIRCULATOR CAME TO WIPE HER FACE OFF. AFTER THE SURGEON WAS WIPED CLEAN, THE SCRUB TECH SAID THAT THE WAND WAS SPRAYING SALINE IN THE BASIN ON THE MAYO STAND AND FOUND THAT THE PUMP WAS STUCK IN A PRIME CYCLE. THE CIRCULATOR TOUCH THE PRIME BUTTON TO SEE IF THAT WOULD STOP THE CYCLE, IT DID NOT. THE CIRCULATOR OPENED THE PUMP DOOR, WHICH STOPPED THE PUMP FROM RUNNING. AFTER REALIZING THE PUMP HAD BEEN RUNNING WITH NO AUDIBLE TONE, WHAT HAD HAPPENED WAS THAT THERE WAS NO TONE TO THE COBLATE OR COAG CYCLE. THERE WAS NO ACCIDENTAL DEPRESSION OF THE FOOT PEDAL, THE PUMP WAS RUNNING RANDOMLY ON ITS OWN. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24519168 ↗
• 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 ↗
• MalfunctionJul 14, 2025Break; Break

  IT WAS REPORTED THAT DURING SURGERY, THE COVER OF THE WEREWOLF CONTROLLER CRACKED IN TWO PIECES. IT IS UNKNOWN IF THERE WAS A BACKUP DEVICE AVAILABLE. THERE WAS A SURGICAL DELAY GREATER THAN 30 MINUTES, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22491482 ↗
• 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 ↗
• MalfunctionApr 11, 2025Failure to Power Up; Intermittent Energy Output; Failure to Power Up; Intermittent Energy Output

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, PUMP OF THE WEREWOLF APL CONTROLLER STARTED AND STOPPED AT RANDOM TIMES, IT WAS POWERING ON AND OFF UNCONTROLLABLY AND THE CONTROLLER DID NOT POWER WANDS WHEN BUTTONS ARE PRESSED ON WAND. THE PROCEDURE WAS COMPLETED WITH A SMITH AND NEPHEW BACK UP DEVICE. THERE WAS A DELAY GREATER THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21826126 ↗
• MalfunctionSep 18, 2024Failure to Shut Off; Failure to Shut Off

  IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, THE WEREWOLF CONTROLLER WAS ACTIVATING WHEN IT WAS NOT IN USE. THE PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY USING A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20251177 ↗
• InjuryAug 7, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING A BILATERAL MYRINGOTOMY WITH ADENOIDECTOMY, THE WEREWOLF CONTROLLER HAD A DEFECT IN THE SHEATH AND THE PATIENT SUFFERED A SUPERFICIAL MUCOSAL ABRASION. THE PATIENT WAS TREATED WITH BACITRACIN IN THE OR SUITE. THE PROCEDURE WAS COMPLETED WITH A S+N BACK UP DEVICE. THERE WAS A DELAY LESS THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 19927738 ↗
• MalfunctionMay 13, 2024Device Alarm System; No Display/Image; Unexpected Shutdown; Device Alarm System; No Display/Image; Unexpected Shutdown

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE WEREWOLF CONTROLLER WAS SHUTTING DOWN. THE POWER CORD WAS CHECKED TO MAKE SURE IT WAS IN POSITION. THE CONSOLE RESTARTED, BUT LATER IN THE PROCEDURE, THE MALFUNCTION OCCURRED AGAIN.. THE PROCEDURE WAS COMPLETED WITH A ARTHREX DEVICE. THERE WAS A DELAY GREATER THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19300396 ↗
• MalfunctionFeb 29, 2024Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT DURING A PROCEDURE, THE WEREWOLF CONTROLLER HAD AN ERROR MESSAGE, STATING "SYSTEM COMMUNICATION FAULT". THE PROCEDURE WAS COMPLETED WITH 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 18807086 ↗
• MalfunctionJan 30, 2024Overheating of Device; Smoking; Overheating of Device; Smoking

  IT WAS REPORTED THAT THE WEREWOLF CONTROLLER WAS DAMAGED, IT WAS OVERHEATING AND SMOKE WAS COMING FROM THE DEVICE. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18607759 ↗
• MalfunctionJan 14, 2024Overheating of Device; Noise, Audible; Overheating of Device; Noise, Audible

  IT WAS REPORTED THAT DURING SET UP, FLUID GOT ON THE THE WEREWOLF CONTROLLER, IT HAD A LOUD NOISE AND SMELLED HOT. A BACK UP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE. THERE WAS NO SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18509828 ↗
• MalfunctionJan 9, 2024Overheating of Device; Intermittent Energy Output; Overheating of Device; Intermittent Energy Output

  IT WAS REPORTED THAT THE WEREWOLF CONTROLLER HAD AN INTERMITTENT MALFUNCTION, IT WAS VERY HOT AND WAS NOT RUNNING. NO CASE WAS REPORTED, THEREFORE, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18478174 ↗

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