COBLATION 72290037Recalls & reported problems

Summary

The FDA's MAUDE database contains 65 adverse event reports that list this exact device (DI 00885556617472), received between Dec 1, 2017 and Apr 17, 2026 — classified as 10 injuries, 55 malfunctions.

The most frequently reported specific device problem is “Self-Activation or Keying” (12 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 65 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 17, 2026Material Separation; Electrical Shorting

  IT WAS REPORTED THAT, DURING A SURGERY, ONE (1) WEREWOLF FLOW 50 COBLATION WAND DISPLAYED THE ERROR MESSAGE "WAND SHORT CIRCUIT". ALSO, WHEN THE WAND WAS REMOVED FROM THE JOINT, IT WAS NOTICED THAT A TIP ELECTRODE FELL OFF INSIDE THE PATIENT¿S BODY. THE TIP ELECTRODE WAS REMOVED FROM THE BODY. 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 24912109 ↗
• MalfunctionFeb 11, 2026Self-Activation or Keying

  IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, THE ABLATION FUNCTION OF THE WEREWOLF FLOW 50 WAND WAS ACTIVATING WITHOUT THE BUTTON BEING PRESSED. IT IS UNKNOWN HOW THE PROCEDURE WAS PERFORMED; HOWEVER, THERE WAS NO DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24318508 ↗
• MalfunctionFeb 4, 2026Physical Resistance/Sticking

  IT WAS REPORTED THAT, DURING SURGERY, THE ELECTRODE OF ONE (1) WEREWOLF FLOW 50 COBLATION WAND DID NOT FUNCTION PROPERLY. THE BUTTON REMAINED STUCK ON THE ¿ON¿ POSITION EVEN THOUGH THE SURGEON WAS NOT LONGER PRESSING IT. THE PROCEDURE WAS RESUMED, USING AN EQUIVALENT S+N BACKUP; HOWEVER, IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24261367 ↗
• InjuryNov 30, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A HIP SCOPE, A PIECE OF THE WEREWOLF FLOW 50 COBLATION WAND FELL OFF AS IT WAS COBLATING. HE TRIED TO REMOVE IT FOR A WHILE BUT WAS UNSUCCESSFUL AND CLOSED UP WITH THE SMALL PIECE STILL IN THE JOINT. SURGEON IS UNSURE IF A REVISION SURGERY WILL BE NEEDED TO REMOVE FOREIGN MATERIAL. THE PROCEDURE WAS COMPLETED WITH THE SAME SN PRODUCT. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 23677083 ↗
• MalfunctionNov 27, 2025Device Alarm System; Self-Activation or Keying; Device Alarm System; Self-Activation or Keying

  IT WAS REPORTED THAT, DURING A KNEE ARTHROSCOPY, THE BUTTON OF THE WEREWOLF WAND WAS RELEASED BUT IT CONTINUED TO BE ACTIVATED UNTIL THE SYSTEM FAULTED AND AN ERROR MESSAGE APPEARED TELLING TO SHUT DOWN THE CONSOLE AND RESTART. IT ALSO CAUSED THE MACHINE TO ALARM UNTIL THE WAND WAS UNPLUGGED. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT SN BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23665702 ↗
• MalfunctionSep 22, 2025Device Alarm System; Overheating of Device; Protective Measures Problem; Device Alarm System; Overheating of Device; Protective Measures Problem

  IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, THE WEREWOLF FLOW 50 COBLATION WAND DISPLAYED A TEMPERATURE ALARM AND THE TEMPERATURE DISPLAY ON THE MONITOR WAS RAISING EVEN THOUGH THE WAND WAS MOVED AWAY FROM THE PATIENT¿S JOINT AND WAS NOT BEING USED. IT IS UNKNOWN HOW THE PROCEDURE WAS PERFORMED. NO SURGICAL DELAY OR FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23109305 ↗
• MalfunctionAug 20, 2025Self-Activation or Keying; Communication or Transmission Problem; Self-Activation or Keying; Communication or Transmission Problem

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE, THE WEREWOLF COBLATION WAND WAS NOT IN USE WHEN THE TEMPERATURE ROSE. A "WAND AMBIENT SENSOR NOT DETECTED" MESSAGE THEN APPEARED ON THE CONTROLLER'S SCREEN. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SURGICAL DELAY BUT IT IS UNKNOWN HOW THE ISSUE WAS RESOLVED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22852788 ↗
• MalfunctionAug 4, 2025Self-Activation or Keying; Self-Activation or Keying

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE, THE WEREWOLF WAND WAS ACTIVATED ALTHOUGH THE BUTTON WAS NOT PRESSED. THE PROCEDURE WAS COMPLETED USING A BACK-UP DEVICE AND IT UNKNOWN IF THERE WAS SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22700380 ↗
• InjuryMay 21, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY AND ROTATOR CUFF REPAIR, THE WEREWOLF FLOW 50 WAND WAS NO LONGER CAUTERIZING AS INTENDED. WHEN THE WAND WAS WITHDRAWN FROM THE PATIENT'S ARTHROSCOPIC PORT FOR INSPECTION, A METAL PLATE THAT IS NORMALLY SECURED TO THE OPERATIVE TIP WAS FOUND TO BE MISSING. AN INTRAOPERATIVE X-RAY WAS OBTAINED BEFORE THE WOUND WAS CLOSED, AND THE DOCTOR STATED, 'WE CAN SEE OUR SUTURE ANCHORS, BUT OTHERWISE, IT LOOKS CLEAR TO ME.'. FURTHER DEBRIDEMENT WAS THEN PERFORMED, FOLLOWED BY BONY RESECTION USING AN ARTHROSCOPIC BURR ON THE UNDERSIDE OF THE ANTERIOR AND LATERAL ACROMION TO ACHIEVE A FLAT UNDERSURFACE. AT THAT POINT, GIVEN THE SIGNIFICANT PATHOLOGY IN THE SHOULDER, IT WAS DECIDED TO TRANSITION TO AN OPEN PROCEDURE. THE SETTINGS USED IN THE CONTROLLER WERE HIGH. THE PROCEDURE WAS COMPLETED WITH A 2-MINUTE SURGICAL DELAY USING A BACK-UP DEVICE. THERE ARE NO ISSUES WITH THE CURRENT STATUS OF THE PATIENT, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 22067132 ↗
• MalfunctionMar 31, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE, THE METAL PIECE OF THE WEREWOLF COBLATION WAND CAME OUT DURING COAGULATION. THE METAL PIECE WAS REMOVED USING A GRASPER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A 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 21733810 ↗
• MalfunctionMar 14, 2025Self-Activation or Keying; Physical Resistance/Sticking; Self-Activation or Keying; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A MULTILIGAMENT KNEE REPAIR THE ON/OFF BUTTON OF THE WEREWOLF FLOW 50 COBLATION WAND WAS "STICKY" SO THE WAND COULD NOT BE TURNED OFF PROPERLY. 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 21606901 ↗
• MalfunctionMar 11, 2025Failure to Shut Off; Failure to Shut Off

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE BUTTON OF ONE (1) WEREWOLF FLOW 50 COBLATION WAND GOT STUCK AND CONTINUED TO ABLATE AFTER THE SURGEON STOPPED. THE DEVICE HAD TO BE UNPLUGGED FOR IT TO STOP. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT SURGICAL DELAY, WITH A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21574536 ↗
• MalfunctionNov 5, 2024Break; Activation Failure; Break; Activation Failure

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, AFTER 7 MINUTES OF USE , THE ABLATE FUNCTION OF THE WEREWOLF FLOW WAND STOPPED WORKING. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DELAY OF 2 MINUTES USING A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20614971 ↗
• MalfunctionOct 1, 2024Device Remains Activated; Self-Activation or Keying; Device Remains Activated; Self-Activation or Keying

  IT WAS REPORTED THAT DURING A HIP ARTHROSCOPY THE FLOW 50 WAND KEPT ON GOING WHILE NO BUTTON WAS TOUCHED OR THE FOOT PEDAL WAS NOT USED. SO THE PROBE HAS HIS ON WILL. 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 20349489 ↗
• MalfunctionSep 3, 2024Overheating of Device; Infusion or Flow Problem; Overheating of Device; Infusion or Flow Problem

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE OVERHEATING ALARM ON THE WEREWOLF COBLATION WAND WAS TRIGGERED. IT WAS OBSERVED THAT NO FLUID WAS FLOWING THROUGH THE SUCTION TUBE. UPON ATTEMPTING TO USE THE DEVICE AGAIN, IT RAPIDLY OVERHEATED, AND STILL NO FLUID WAS MOVING THROUGH IT. INSPECTION REVEALED THAT A HIGH-PRESSURE HOSE HAD BEEN USED WITH THE DEVICE, AND IT APPEARED THAT A BLOCKAGE WAS LODGED INSIDE, IMPEDING FLUID FLOW. 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20131959 ↗
• MalfunctionAug 9, 2024Failure to Shut Off; Failure to Shut Off

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE ABLATION SOUND OF WEREWOLF FLOW 50 WAND KEPT ONGOING FROM THE CONSOLE AND THE WAND WAS STILL BURNING AND UNABLE TO STOP, EVEN WHEN PRESSING THE STOP BUTTON. 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 19951435 ↗
• MalfunctionNov 8, 2023Self-Activation or Keying; Self-Activation or Keying

  IT WAS REPORTED THAT DURING AN ACL PROCEDURE, THE WEREWOLF FLOW 50 WAND BUTTON WAS STUCK IN THE ON POSITION AND THE WAND KEPT ABLATING BY ITSELF. THE PROCEDURE WAS COMPLETED WITH NON-SIGNIFICANT DELAY USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18093316 ↗
• MalfunctionOct 18, 2023Self-Activation or Keying; Self-Activation or Keying

  IT WAS REPORTED THAT THE WEREWOLF FLOW 50 WAND RAN BY ITSELF AND THEN STOPPED. IT IS UNKNOWN WHETHER THE EVENT HAPPENED DURING SURGERY AND IF THERE WAS PATIENT INVOLVEMENT AND IF THERE WAS A BACK-UP DEVICE AVAILABLE OR IF THERE WAS A DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17959228 ↗
• MalfunctionAug 3, 2023Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY, A PART OF THE ELECTRODE OF THE WEREWOLF FLOW 50 COBLATION WAND DETACHED. THE BROKEN PIECE WAS REMOVED, AND PATIENT WAS STABLE. THE PROCEDURE WAS COMPLETED WITH 10 MINUTES OF 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 17451552 ↗
• MalfunctionMay 2, 2023Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY, THE WEREWOLF WAND SEEMED TO HAVE A STICKY OR FAULTY BUTTON, IT WOULD ACTIVATED EVEN WHEN THE BUTTONS WERE NOT BEING PRESSED AND IT WAS ALARMING THAT TWO BUTTONS WERE PRESSED WHEN ONLY ONE WAS BEING USED. THE PROCEDURE WAS COMPLETED WITH A S+N BACK UP DEVICE. THERE WAS A NON-SIGNIFICANT SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16856894 ↗
• InjuryMar 1, 2023Flaked; Flaked

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY, THE WEREWOLF WAND SHOWED WEAR OR DETACHMENT OF METAL MATERIAL AT ITS TIP, THE ABLATION BUTTON WAS PRESSED WITH NO EFFECT ON THE USE OF THE WAND. SETTINGS TOTAL 0:39 HI0:15 VAC0:17. THE DEVICE DID DISLODGE METALLIC MATERIAL INSIDE THE PATIENT, THE METALLIC MATERIAL WAS NOT RECOVERED, THE RESIDUE WAS LEFT INSIDE THE PATIENT (LIKE FROST). THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NON-SIGNIFICANT DELAY USING A S+N BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 16461560 ↗
• MalfunctionDec 27, 2022Melted; Melted

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY, THE BLACK MATERIAL OF THE COBLATION WAND WAS MELTING. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NON-SIGNIFICANT DELAY USING A S+N BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16057769 ↗
• MalfunctionDec 8, 2022Self-Activation or Keying; Self-Activation or Keying

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE, THE ABLATE FUNCTION OF THE WEREWOLF WAND WAS ACTIVATED ALTHOUGH THE BUTTON WAS NOT PRESSED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15942173 ↗
• MalfunctionSep 3, 2022Failure to Shut Off; Failure to Shut Off

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE WITH WEREWOLF FLOW COBLATION WAND, THE ABLATE FUNCTION DID NOT STOP ALTHOUGH THE BUTTON WAS NOT PRESSED. THE PROCEDURE WAS COMPLETED WITH A 5 MINUTES SURGICAL DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15353603 ↗
• MalfunctionJun 20, 2022Self-Activation or Keying; Self-Activation or Keying

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE WEREWOLF COBLATION WAND CONTINUED TO WORK EVEN THOUGH THE HANDLE WAS NOT ACTIVATED. THE PROCEDURE WAS COMPLETED WITH A NON-SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14747955 ↗