COBLATION 72290038Recalls & reported problems

Summary

The FDA's MAUDE database contains 190 adverse event reports that list this exact device (DI 00885556647462), received between Jun 9, 2020 and Apr 23, 2026 — classified as 19 injuries, 171 malfunctions.

The most frequently reported specific device problem is “Self-Activation or Keying” (43 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 190 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 23, 2026Device Alarm System; Break; Electrical Shorting

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC LABRAL REPAIR OF THE ACETABULAR JOINT, THE WEREWOLF FLOW 90 WAND TRIGGERED AN ALARM ON THE MAIN UNIT INDICATING THAT THE WAND WAS BROKEN INTO PIECES AFTER A PERIOD OF USE. THE PIECES WERE REMOVED FROM INSIDE THE PATIENT. THE PROCEDURE WAS RESUMED USING AN EQUIVALENT S+N BACKUP, AFTER A NON-SIGNIFICANT DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24975152 ↗
• MalfunctionMar 30, 2026Overheating of Device; Smoking

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, THE ELECTRODE OF THE WEREWOLF FLOW 90 WAND OVERHEATED AND SMOKE. THE PROCEDURE WAS COMPLETED WITHOUT A SURGICAL DELAY USING AN EQUIVALENT S&N BACK-UP DEVICE. NO FURTHER COMPLICATIONS OR CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24724479 ↗
• MalfunctionMar 23, 2026Flaked

  IT WAS REPORTED THAT, DURING AN ARCR SURGERY, THE BLACK COATING OF THE SHAFT OF ONE (1) WEREWOLF FLOW 90 COBLATION WAND, PEELED OFF. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK-UP. ADDITIONAL ANESTHESIA WAS NOT REQUIRED AS CONSEQUENCE OF THE SURGICAL PROLONGATION. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24670595 ↗
• MalfunctionMar 3, 2026Overheating of Device

  IT WAS REPORTED THAT, DURING AN UNSPECIFIED PROCEDURE, A TEMPERATURE RISE ALARM SOUNDED AND THE MONITORING TEMPERATURE INDICATED OVER 60 DEGREES CELSIUS AT THE START OF USE OF THE WEREWOLF COBLATION WAND. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24495928 ↗
• MalfunctionNov 11, 2025Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT, DURING A SHOULDER DECOMPRESSION PROCEDURE, THE PLASTIC SHAFT BEGAN TO COME AWAY FROM A WEREWOLF FLOW 90 WORKING END. THE SURGEON ATTEMPTED TO REMOVE THE PLASTIC, BUT THE DEVICE DID NOT WORK FOLLOWING THIS. NO PLASTIC PIECES FELL INTO THE PATIENT'S WOUND. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT SURGICAL DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23526766 ↗
• MalfunctionOct 27, 2025Overheating of Device; Electrical Shorting; Overheating of Device; Electrical Shorting

  IT WAS REPORTED THAT DURING AN ACROMIOPLASTY, TWO (2) WEREWOLF FLOW 90 WANDS OVERHEATED AND REACHED TEMPERATURES OF 56¿60 DEGREES CELSIUS, EVEN THOUGH THE PRODUCT WAS IN THE AIR, NOT OBSTRUCTED, AND PLACED IN THE POUCH WITHOUT SUCTION. THE SAME ERROR MESSAGE APPEARED WITH TWO DIFFERENT HANDPIECES, INDICATING A ¿SHORT CIRCUIT IN THE WAND.¿ THE PROCEDURE WAS COMPLETED AFTER A SURGICAL DELAY OF APPROXIMATELY 10 MINUTES USING A SIMILAR SN BACKUP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23391952 ↗
• MalfunctionOct 24, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT, DURING A SHOULDER ARTHROSCOPY, THE WEREWOLF FLOW 90 COBLATION WAND DID NOT STOP WORKING, THE BUTTON WAS BROKEN. THE PROCEDURE WAS RESUMED, WITH A NON-SIGNIFICANT SURGICAL DELAY, USING AN EQUIVALENT S+N BACK-UP. THE PATIENT WAS NOT EXPOSED TO ADDITIONAL ANESTHESIA. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23379884 ↗
• MalfunctionOct 10, 2025Flaked; Flaked

  IT WAS REPORTED THAT, DURING A SURGERY, THE SHAFT'S COATING OF THE WEREWOLF FLOW WAND WAS DAMAGED. IT DID NOT FALL INSIDE THE BODY. THE PROCEDURE WAS COMPLETED WITHOUT A SURGICAL DELAY USING AN EQUIVALENT SN BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23264778 ↗
• MalfunctionJul 24, 2025Self-Activation or Keying; Self-Activation or Keying

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC PROCEDURE, THE ABLATE FUNCTION OF THE WEREWOLF WAND WAS ACTIVATED ALTHOUGH THE BUTTON WAS NOT BEING PRESSED. THE PROCEDURE WAS SUCCESSFULLY 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 22603945 ↗
• MalfunctionJun 27, 2025Degraded; Degraded

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY, THE BLACK COATING ON THE SHAFT OF THE WEREWOLF FLOW 90 COBLATION WAND STARTED TO PEEL OFF. THE PROCEDURE WAS COMPLETED WITH 5 MINUTES DELAY USING THE SAME DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22350556 ↗
• MalfunctionJun 19, 2025Device Alarm System; Self-Activation or Keying; Insufficient Device Problem Information; Device Alarm System; Self-Activation or Keying; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE WEREWOLF FLOW 90 COBLATION WAND ACTIVATED BY ITSELF, TRIGGERING THE HEAT WARNING ALARM ON THE WEREWOLF CONSOLE AND INCREASING THE TEMPERATURE, WHICH CONTINUED TO REPEAT UNTIL THE DEVICE WAS UNPLUGGED AND REMOVED. THE PROCEDURE WAS COMPLETED USING AN S+N BACKUP DEVICE. THERE WAS A DELAY OF LESS THAN 30 MINUTES. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22290625 ↗
• MalfunctionApr 25, 2025Electrical Shorting; Electrical Shorting

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, FOUR WEREWOLF 90 COBLATION WANDS GIVE AN ERROR MESSAGE ON SCREEN ("ERROR - WAND SHORT CIRCUIT. PLEASE REPLACE WAND") WHEN CONNECTED TO THE WEREWOLF MACHINE (THEY WERE TESTED IN TWO DIFFERENT WEREWOLF MACHINES). THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A SURGICAL DELAY GREATER THAN 30 MINUTES USING A DIFFERENT SURGICAL TECHNIQUE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21911660 ↗
• MalfunctionApr 11, 2025Self-Activation or Keying; Self-Activation or Keying

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE WEREWOLF FLOW 90 COBLATION WAND DID NOT STOP TO ABLATE. THE PROCEDURE WAS COMPLETED USING A S+N BACK UP DEVICE. THERE WAS A DELAY OF LESS THAN 30 MINUTES. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21827528 ↗
• MalfunctionMar 25, 2025Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING SHOULDER PROCEDURE, A WEREWOLF FLOW 90 UNIT, WAS OVERHEATING, AND THE PROBLEM PERSISTS EVEN AFTER REMOVING THE WAND AND PLACING IT IN COLD WATER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A SMITH AND NEPHEW BACK UP DEVICE AND A SURGICAL DELAY GREATER THAN 30 MINUTES. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21691695 ↗
• MalfunctionMar 25, 2025Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING SHOULDER PROCEDURE, TWO WEREWOLF FLOW 90 UNITS, ALL EXPERIENCED THE SAME ISSUE ¿ THEY WERE OVERHEATING, AND THE PROBLEM PERSISTS EVEN AFTER REMOVING THE WAND AND PLACING IT IN COLD WATER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A SMITH AND NEPHEW BACK UP DEVICE AND A SURGICAL DELAY GREATER THAN 30 MINUTES. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21691688 ↗
• MalfunctionMar 17, 2025Self-Activation or Keying; Self-Activation or Keying

  IT AS REPORTED THAT DURING AN ARTHROSCOPY, THE WEREWOLF FLOW 90 COBLATION WAND WAS NOT TURNING OFF SO IT WOULD NOT STOP ABLATING ONCE THE YELLOW BUTTON ON THE HAND PIECE WAS RELEASED. THERE WAS NO HARM OR COMPLICATION DURING OR SINCE THE OPERATION. THE PROCEDURE WAS COMPLETED WITH A SMITH AND NEPHEW BACK UP DEVICE. THERE WAS A DELAY LESS THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21627840 ↗
• MalfunctionMar 13, 2025Corroded; Self-Activation or Keying; Corroded; Self-Activation or Keying

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR, AFTER ABOUT 17 MINUTES OF ACTIVATION, THE WEREWOLF COBLATION WAND STARTED ACTIVATING ON ITS OWN WITHOUT PRESSING BUTTONS OR THE FOOT PEDAL, AND AN ERROR MESSAGE "MULTIPLE BUTTONS PRESSED AT ONCE" APPEARED. THE FOOT PEDAL WAS DISCONNECTED, LEAVING ONLY BUTTON ACTIVATION. THE PROCEDURE WAS COMPLETED WITH A SURGICAL DELAY OF LESS THAN 30 MINUTES USING A SMITH AND NEPHEW BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21598083 ↗
• MalfunctionFeb 18, 2025Self-Activation or Keying; Physical Resistance/Sticking; Self-Activation or Keying; Physical Resistance/Sticking

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, THE WEREWOLF FLOW 90 WAND BUTTONS WERE STICKING AND GENERATE PLASMA CONTINUOUSLY WITHOUT ACTIVATION, THEN SHOWED AN ERROR MESSAGE ON THE SCREEN, THE FOOT PEDAL WAS STILL WORKING, BUT THEN THE SCREEN KEPT REVERTING BACK TO THE STARTUP SCREEN, SO THE WAND WAS UNPLUGGING AND PLUGGING BACK TO GET IT TO WORK. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE INSTEAD. THERE WAS A SURGICAL DELAY OF LESS THAN 30 MINUTES, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21397494 ↗
• MalfunctionFeb 15, 2025Leak/Splash; Failure to Shut Off; Protective Measures Problem; Leak/Splash; Failure to Shut Off; Protective Measures Problem

  IT WAS REPORTED THAT WHEN PULLING DATA FROM THE WEREWOLF FLOW 90 COBLATION WAND, THE BUTTONS WERE ALL ACTIVATED, AND PRESSING THE BUTTONS DID NOT TURN THEM OFF, REMOVING THE BUTTON COVERS REVEALED LIQUID INGRESS IN THE BUTTON BOARD. THE WAND DATA SHOWED THE WAND EXPERIENCED A MULTIPLE-BUTTON PRESS WARNING. THE DEFICIENCY WAS OBSERVED WHILE PERFORMING THE INVESTIGATION FOR THE DEVICE; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21390619 ↗
• MalfunctionJan 28, 2025Self-Activation or Keying; Self-Activation or Keying

  IT WAS REPORTED THAT THE WAND AUTOMATICALLY STARTED COBLATING AFTER BEING PLUGGED INTO THE CONSOLE, WITHOUT PRESSING ANY HAND/FOOT SWITCH. 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. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21261146 ↗
• MalfunctionDec 21, 2024Self-Activation or Keying; Self-Activation or Keying

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY, THE WEREWOLF FLOW 90 COBLATION WAND WOULD NOT DISENGAGE AND CONTINUED TO COAGULATE/ABLATE, WHILE NO BUTTONS WERE BEING PUSHED. THEY ATTEMPTED TO HOOK UP THE FOOT PEDAL AND ENCOUNTERED THE SAME RESULTS. THE PROCEDURE WAS COMPLETED USING A S+N BACK UP DEVICE. THERE WAS NO SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20996882 ↗
• MalfunctionDec 6, 2024Self-Activation or Keying; Self-Activation or Keying

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY SUBACROMIAL DECOMPRESSION, WHEN THE ABLATION BUTTON WAS RELEASED, THE WEREWOLF FLOW 90 WAND MAINTAINED ACTIVATED. SURGERY WAS COMPLETED USING A SMITH AND NEPHEW BACK-UP DEVICE INSTEAD. THERE WAS A DELAY OF LESS THAN 30 MINUTES, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20860252 ↗
• MalfunctionDec 3, 2024Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE TEMPERATURE OF THE WAND DID NOT DECREASE, AND AN ERROR TONE KEPT SOUNDING, MAKING IT UNUSABLE. THE PROCEDURE WAS COMPLETED USING A BACK-UP DEVICE. NO DELAY WAS REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20835492 ↗
• MalfunctionNov 27, 2024Corroded; Self-Activation or Keying; Key or Button Unresponsive/not Working; Corroded; Self-Activation or Keying; Key or Button Unresponsive/not Working

  IT WAS REPORTED THAT 20 MINUTES AFTER AN ACROMIOPLASTY THE WEREWOLF WAS MAKING THE COAG SOUND EVEN THOUGH THE WAND WAS NOT ACTIVATED, AND THE TOUCH SCREEN WAS SHOWING THAT COAG FUNCTION WAS BEING ACTIVATED. THE BACK BUTTON WAS PRESSED TO STOP THE WAND BUT THEN WHEN THE DOCTOR WANTED TO USE THE COBLATION (YELLOW BUTTON) THE MACHINE ERROR-MESSAGED THAT 2 BUTTONS WERE BEING PRESSED SIMULTANEOUSLY. THE PROCEDURE WAS COMPLETED USING A BACK-UP DEVICE. THERE WAS NO SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20797483 ↗
• MalfunctionOct 28, 2024Self-Activation or Keying; Self-Activation or Keying

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE WEREWOLF FLOW WAND WAS CONTINUOUSLY ACTIVATING ON COBLATE MODE WITHOUT HAVING THE BUTTON PRESSED. NO FOOT PEDAL WAS PLUGGED IN AND THE BUTTON WAS NOT BEING PRESSED BY THE CONSULTANT. THE WAND WORKED PERFECTLY FOR THE FIRST 30 MINUTES OF THE CASE BEFORE IT STARTED TO DO THIS. DISCONNECTING AND RECONNECTING THE WAND DID NOT STOP IT ACTIVATING WITHOUT BUTTONS BEING PRESSED. THE PROCEDURE WAS COMPLETED WITH A SURGICAL DELAY OF LESS THAN 30 MINUTES USING A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20544970 ↗