WEREWOLF+ 72290146Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00885556787236), received between Jan 7, 2022 and Apr 8, 2026 — classified as 1 injury, 21 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, 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 22 most recent of 22 reports, 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 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionJan 9, 2024Overheating of Device; Failure to Power Up; Overheating of Device; Failure to Power Up

  IT WAS REPORTABLE THAT THE WEREWOLF CONTROLLER WOULD NOT TURN ON, WAS VERY HOT AND WAS NOT RUNNING. NO CASE INVOLVED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18475751 ↗
• MalfunctionJan 5, 2024Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING SET UP, THE WEREWOLF CONTROLLER SCREEN WAS NOT WORKING, THE DEVICE WAS VERY HOT AND NOT RUNNING. THERE WAS A SMITH AND NEPHEW BACK UP DEVICE AVAILABLE AND NO SURGICAL DELAY WAS REPORTED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18454097 ↗
• MalfunctionNov 14, 2023Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE WEREWOLF CONTROLLER WAS OVERHEATING. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18132826 ↗
• MalfunctionOct 30, 2023Smoking; Smoking

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE WEREWOLF CONTROLLER STARTED SMOKING DURING THE PROCEDURE AND SHUT OFF. THE PROCEDURE WAS COMPLETED WITH NON-SIGNIFICANT SURGICAL DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18035833 ↗
• MalfunctionAug 31, 2023Smoking; Smoking

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, AFTER 2 MINUTES THAT THE WEREWOLF WAND WAS INSERTED INTO THE WEREWOLF CONTROLLER, THERE WAS SMOKE IMMERSING FROM THE PLUG AND THE MACHINE INDICATED AN ERROR. THE PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY USING A S+N BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17663300 ↗
• MalfunctionAug 16, 2023Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE WEREWOLF CONTROLLER WAS PULLING TOO MUCH SUCTION AND WAS OVERHEATING. IT IS UNKNOWN WHETHER THE EVENT HAPPENED DURING SURGERY, IF THERE WAS PATIENT INVOLVEMENT, IF THERE WAS A BACK-UP DEVICE AVAILABLE OR IF THERE WAS A DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17558118 ↗
• MalfunctionMar 8, 2023Smoking; Sparking; Communication or Transmission Problem; Electrical Shorting; Smoking; Sparking; Communication or Transmission Problem; Electrical Shorting

  IT WAS REPORTED THAT DURING SET UP, THE WEREWOLF CONTROLLER MONITOR DOES NOT RESPOND TO MACHINE BEING TURNED ON. A LOUD POP WAS HEARD WITH INITIAL POWER-ON OF THE DAY, FOLLOWED BY SMOKE PLUME; THE DEVICE DID SPARK AND THE SMELL OF HOT ELECTRICITY WAS ACKNOWLEDGED. A BACK UP DEVICE WAS AVAILABLE AND THERE WAS NO DELAY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16503096 ↗
• MalfunctionMar 1, 2023Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE INTERNAL COOLING FAN OF THE WEREWOLF APL CONTROLLER DID NOT WORK PROPERLY. THE FAN WAS SUCKING AIR INTO THE UNIT VS BLOWING THE HOT AIR OUT. THIS WAS CAUSING THE UNIT TO RUN HOT AND NOT OPERATE 100%. ALSO, IT CAUSED A BURNT SMELL AFTER SEVERAL MINUTES/HOURS OF USE. THE EVENT OCCURRED DURING LAB/DEMO SERVICE THEREFORE THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16460456 ↗
• MalfunctionJan 12, 2023Self-Activation or Keying; Self-Activation or Keying

  IT WAS REPORTED THAT DURING A PROCEDURE, THE WEREWOLF CONTROLLER DID NOT STOP EVEN AFTER THE ELECTROSURGICAL PENCIL BUTTON WAS RELEASED, CAUSING IT TO RUN WITHOUT ACTIVATION. 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 16146630 ↗
• MalfunctionJun 13, 2022Electrical Shorting; Electrical Shorting

  IT WAS REPORTED THAT, DURING AN UNKNOWN PROCEDURE, A WEREWOLF CONTROLLER WAS NOT WORKING. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. DURING INVESTIGATION IT WAS FOUND THAT THE DEVICE HAD SMOKE COMING FROM THE POWER SUPPLY FANS AREA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14678270 ↗
• MalfunctionJan 7, 2022Unintended Power Up; Unintended Power Up

  IT WAS REPORTED THAT DURING A SHOULDER SURGERY, THE WEREWOLF CONTROLLER WILL TURN ON AUTOMATICALLY WITHOUT A WAND BEING PRESSED. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13192705 ↗