RF20000 72290105Recalls & reported problems

Summary

The FDA's MAUDE database contains 115 adverse event reports that list this exact device (DI 00885556624890), received between Apr 6, 2018 and Feb 14, 2026 — classified as 8 injuries, 107 malfunctions.

The most frequently reported specific device problem is “Communication or Transmission Problem” (21 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 115 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 14, 2026Device Alarm System; No Display/Image

  IT WAS REPORTED THAT, DURING A KNEE ARTHROSCOPIC PROCEDURE, THE WEREWOLF CONTROLLER'S SCREEN DID NOT DISPLAY ANYTHING, EVEN THOUGH THE MACHINE POWERED ON. ADDITIONALLY, THERE WAS AN ERROR SOUND. THE PROCEDURE WAS RESUMED, WITH A 2 HOUR DELAY, USING A SIMILAR S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24340870 ↗
• MalfunctionApr 1, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE WEREWOLF CONTROLLER HAD A HARDWARE FAILURE. THE PROCEDURE WAS COMPLETED USING A 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 21749219 ↗
• MalfunctionJun 7, 2024Device Alarm System; No Display/Image; Device Alarm System; No Display/Image

  IT WAS REPORTED THAT DURING A PROCEDURE, THE WEREWOLF CONTROLLER'S START UP SCREEN DID NOT APPEAR, IT WAS JUST BLACK AND THE ALARM STARTED TO SOUND. THE PROCEDURE WAS COMPLETED WITH A CHANGE IN THE SURGICAL TECHNIQUE USING A 4.5 INCISOR TO DEBRIDEMENT CARTILAGE OF MENISCUS, AND A SURGICAL DELAY GREATER THAN 30 MINUTES. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19490451 ↗
• MalfunctionJun 3, 2024Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING SET UP, THE WEREWOLF CONTROLLER MOTOR WAS NOT ENGAGING ENOUGH TO PROPERLY SPIN, THE HAND PIECE WAS ALSO OVERHEATING SHORTLY AFTER BEING STARTED. 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 19454777 ↗
• MalfunctionMar 1, 2024Overheating of Device; Electrical Shorting; Material Deformation; Overheating of Device; Electrical Shorting; Material Deformation

  IT WAS REPORTED THAT DURING SET UP, THE PLUG IN FROM THE WEREWOLF CONTROLLER WAS BURNT, AND THE FOLLOWING ERROR MESSAGE WAS DISPLAYED: WAND SHORT CIRCUIT, PLEASE REPLACE WAND. ADDITIONALLY, THE REPORTED DEVICE WAS OVERHEATING. THERE WAS A 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 18818484 ↗
• MalfunctionDec 6, 2023Unintended Power Up; Unintended Power Up

  IT WAS REPORTED THAT DURING SET UP OR INSPECTION, THE WAND CONNECTED TO WEREWOLF RF20000 CONTROLLER WAS OPERATING BY IT SELF. THERE WAS NO DELAY AND NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18279076 ↗
• InjuryApr 24, 2023Power Problem; Power Problem

  IT WAS REPORTED THAT ON THE PMCF "PMCF FOR TURBOVAC 90 XL ICW, MULTIVAC 50 XL ICW & TOPAZ EZ IFS", WAS FOUND THAT DURING A PROCEDURE, THE WEREWOLF RF 20000 CONTROLLER TOOK TOO LONG TO TURN ON. THE PATIENT HAD TO BE REVISED DUE TO REBLEEDING. PATIENTS¿ OUTCOME IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16799697 ↗
• InjuryApr 24, 2023Power Problem; Power Problem

  IT WAS REPORTED THAT ON CLINICAL REVIEW PMCF FOR TURBOVAC 90 XL ICW, MULTIVAC 50 XL ICW & TOPAZ EZ IFS, DURING A PROCEDURE TO TREAT A HIP FRACTURE OF 1 PATIENT, WHILE USING A TOPAZ WAND AND A WEREWOLF CONTROLLER THAT TOOK TOO LONG TO TURN ON IN ORDER TO PERFORM THE COAGULATION AND THE PATIENT SUFFERED A BLEEDING THAT WAS DIFFICULT TO CONTROL. AFTER THIS THE PATIENT REQUIRED A REVISION SURGERY DUE TO A REBLEEDING AND REQUIRED HEMOSTASIS. ADDITIONALLY AN ATLAS FOOT PEDAL AND A LENS INTEGRATED SYSTEM WERE USED. PATIENT OUTCOME IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16797090 ↗
• MalfunctionMar 26, 2023Smoking; Noise, Audible; Smoking; Noise, Audible

  IT WAS REPORTED THAT DURING SET UP, A WEREWOLF CONTROLLER HAD WATER SPILL ON IT, MADE A POPPING NOISE AND WAS SMOKING. A BACK UP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16616752 ↗
• MalfunctionMar 20, 2023Smoking; Smoking

  IT WAS REPORTED THAT DURING SET UP OF A PROCEDURE, THE WEREWOLF RF 2000 CONTROLLER BEGAN SMOKING AND MAKING SOUNDS LIKE EXPLODING WHEN IN USE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SURGICAL DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16572721 ↗
• MalfunctionOct 13, 2022Smoking; Smoking

  IT WAS REPORTED THAT, DURING A KNEE ARTHROSCOPY, A WEREWOLF CONTROLLER BEGAN TO SMOKE AND IT SMELLED AS SOMETHING BURNING. SURGERY WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15596767 ↗
• MalfunctionMar 2, 2022Arcing; Noise, Audible; Arcing; Noise, Audible

  IT WAS REPORTED THAT WHEN IT WAS PLUGGED THE KETTLE CORD INTO THE BACK OF THE WEREWOLF MACHINE, A POPPING SOUND WAS HEARD AND IT HAD A SPARK AND A SMALL AMOUNT OF SMOKE COMING OUT FROM THE PLUG OF THE CONTROL UNIT. THE INCIDENT OCCURRED BEFORE THE PROCEDURE. NO DELAY WAS REPORTED. IT IS UNKNOWN IF THERE WAS A BACKUP DEVICE WAS AVAILABLE. NO OTHER COMPLICATIONS WERE REPORTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13656750 ↗
• MalfunctionNov 7, 2021Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT, WHEN A REGULAR 90 DEGREE AMBIENT WAND WAS PLUGGED INTO THE PORT, THE WAND CONTINUES TO RUN AFTER ABLATION WAS SELECTED. HAVE TO UNPLUG AND THEN RE-PLUG INTO THE WEREWOLF CONTROLLER FOR IT TO SHUT OFF. IT IS UNKNOWN WHETHER THE EVENT HAPPENED DURING SURGERY AND IF THERE WAS PATIENT INVOLVEMENT. IT IS UNKNOWN IF THERE WAS A DELAY OR IF A BACKUP DEVICE WAS AVAILABLE AND HOW THE ISSUE WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12756090 ↗
• MalfunctionSep 8, 2021Sparking; Sparking

  IT WAS REPORTED THAT DURING A ROTATOR PROCEDURE, THE WEREWOLF RF 20000 CONTROLLER MADE A LOUD NOISE, BLEW UP SPARKS OUT OF THE REAR OF THE MACHINE WHERE THE FAN IS, AND POWERED OFF. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12443819 ↗
• MalfunctionJul 14, 2021Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY, THE WEREWOLF CONTROLLER WAS OVERHEATING. THE PROCEDURE WAS COMPLETED WITH A DELAY GREATER THAN 30 MINUTES USING THE SAME DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12166675 ↗
• MalfunctionJun 5, 2021Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THE WEREWOLF CONTROLLER WAS NOT RECOGNIZING THE WAND. NO CASE INVOLVED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11944012 ↗
• MalfunctionMay 18, 2021Communication or Transmission Problem; Material Deformation; Communication or Transmission Problem; Material Deformation

  IT WAS REPORTED THAT THE WEREWOLF CONTROLLER DID NOT RECOGNIZE THE WAND WHEN PLUGGED IN. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11845645 ↗
• InjuryMay 10, 2021Protective Measures Problem; Protective Measures Problem

  IT WAS REPORTED THAT, DURING A KNEE ARTHROSCOPY, MENISCAL STITCH, AN ERROR APPEARED: "THE ELECTRODE IS EXPIRED. REPLACE ELECTRODE". THE ELECTRODE WAS NEW, NOT EXPIRED. ANOTHER ELECTRODE WAS OPENED, THE ERROR PERSISTED. WHEN THE GENERATOR IS TURNED ON, THE WINDOWS ARE NOW LIT IN RED, WHICH SHOULD BE BLINKING GREEN. THERE IS AN ERROR MESSAGE ON THE SCREEN. THEY TURNED ON AND OFF THE GENERATOR, DISCONNECTED FROM THE NETWORK, THE ERROR DID NOT DISAPPEAR. THE SURGEON COMPLETED THE PROCEDURE WITHOUT ANY ABLATOR (HE USED SHAVER DURING THE OPERATION). THERE WAS A DELAY OF LESS THAN OR EQUAL TO 30 MIN. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11800974 ↗
• MalfunctionApr 30, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT THE SCREEN OF THE WEREWOLF CONTROLLER DID NOT REGISTER THAT A WAND WAS PLUGGED IN, WHEN IN FACT IT WAS HOOKED UP AND PLUGGED IN PROPERLY. INCIDENT OCCURRED WHILE SETTING-UP TO A SHOULDER PROCEDURE. A BACK-UP DEVICE WAS AVAILABLE AND NO DELAYS OR COMPLICATIONS OCCURRED. 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 11757278 ↗
• MalfunctionApr 23, 2021Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT DURING THE SET UP OF A ROTATOR CUFF REPAIR, THE WEREWOLF RF 20000 CONTROLLER DID NOT RECOGNIZE THAT ABLATOR THAT IS ATTACHED, IT KEPT ASKING FOR IT TO BE ATTACHED. PROCEDURE FINISHED WITH S&N BACKUP DEVICE. NO SURGICAL DELAY OR INJURY TO PATIENT REPORTED DUE THIS 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 11715728 ↗
• MalfunctionApr 19, 2021Failure to Deliver Energy; Failure to Deliver Energy

  IT WAS REPORTED THAT THE WEREWOLF RF 20000 WAS NOT WORKING WHEN IT WAS TURNED ON. NO CASE REPORTED; THEREFORE, NO PATIENT WAS 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 11691489 ↗
• InjuryApr 14, 2021Protective Measures Problem; Noise, Audible; Protective Measures Problem; Noise, Audible

  IT WAS REPORTED THAT DURING THE SET UP BEFORE THE SURGERY THE WEREWOLF STARTING TO MAKE A LOUD NOISE, THERE IS ALSO AN ERROR REPORTED WHEN THE DEVICE IS BEING USED. NO DELAY OR OTHER COMPLICATIONS REPORTED. CHANGE IN SURGICAL TECHNIQUE WAS REQUIRED IN ORDER TO COMPLETE THE SURGERY. 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 11663400 ↗
• MalfunctionApr 11, 2021Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT, DURING SETUP OR INSPECTION FOR AN ARTHROSCOPY PROCEDURE, THE WEREWOLF RF 20000 CONTROLLER HAD A TURRET POPPED OUT, IT WAS POPPED BACK IN TO ALLOW OPENING AND CLOSING OF THE DEVICE. THE WAND WAS NOT RECOGNIZED BY DEVICE, HOWEVER, THE WAND WORKED FINE WHEN USED WITH A DIFFERENT CONSOLE. THE PROCEDURE WAS COMPLETED WITH A BACKUP DEVICE WITH NO PATIENT INJURY. A DELAY EQUAL TO OR LESS THAN 30 MINUTES WAS 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 11646824 ↗
• MalfunctionApr 5, 2021Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT, DURING THE SET-UP OF AN UNKNOWN PROCEDURE, THE WEREWOLF RF 20000 CONTROLLER DID NOT RECOGNIZE THE RF WHEN PLUGGED IN. THE PROCEDURE WAS CANCELLED. A SMITH AND NEPHEW BACK UP DEVICE WAS USED. 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 11616611 ↗
• MalfunctionMar 23, 2021Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT DURING SET UP OR INSPECTION FOR A SHOULDER ARTHROSCOPY, THE WEREWOLF RF 20000 CONTROLLER WAS NOT RECOGNIZING THE WAND. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO PATIENT INVOLVED AT THE MOMENT OF THE INCIDENT. 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 11555976 ↗