NA 72290007Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 00885556618417), received between Aug 3, 2020 and Mar 17, 2026 — classified as 1 injury, 27 malfunctions.

The most frequently reported specific device problem is “Communication or Transmission Problem” (6 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 28 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 17, 2026Failure to Shut Off; Physical Resistance/Sticking

  IT WAS REPORTED THAT, DURING A SHOULDER SCOPE, THE SURGEON WAS USING THE WIRED FOOT PEDAL HE NOTICED THAT WHEN THE RIGHT SIDE/BLUE PEDAL WAS PRESSED ON, IT WAS GETTING STUCK AND WOULD NOT STOP UNTIL IT WAS PRESSED DOWN VERY HARD TO GET THE PEDAL TO RELEASE. 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 24619539 ↗
• MalfunctionSep 17, 2024Corroded; Physical Resistance/Sticking; Corroded; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING SET UP FOR A ROTATOR CUFF REPAIR/ RIGHT SHOULDER ARTHROSCOPY, THE WIRED FOOT PEDAL WAS STICKING. 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 20237246 ↗
• MalfunctionJul 23, 2024Self-Activation or Keying; Physical Resistance/Sticking; Self-Activation or Keying; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING ROUTINE INSPECTION THE FOOT PEDAL WAS STUCK, WHEN IT WAS PRESSED AND ACTIVATED THE PEDAL, IT WAS NOT GETTING RELEASED AND KEPT ACTIVATED THE HANDPIECE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19806342 ↗
• MalfunctionJun 28, 2024Self-Activation or Keying; Physical Resistance/Sticking; Self-Activation or Keying; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING SET UP, WHEN THE WIRED FOOT PEDAL WAS PLUGGED IN BOTH PEDALS ACTIVATED THE WEREWOLF WAND EVEN WITHOUT TOUCHING THEM. THE PEDALS DID NOT ¿BOUNCE BACK¿ AND MADE THE WAND UNPREDICTABLE AND UNUSABLE, THE SPRINGS MIGHT BE BROKEN. 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 19640060 ↗
• InjuryMay 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, APPROXIMATELY SIX (6) MONTHS AFTER AN ACL + MENISCAL ROOT REPAIR PROCEDURE PERFORMED ON (B)(6) 2022, WHERE ONE (1) WIRED FOOT PEDAL (B)(4) WAS USED; A PATIENT EXPERIENCED SEVERAL ADVERSE EVENTS ON DIFFERENT DATES: ON (B)(6) 2024 THE PATIENT HAD SIGNIFICANT PAIN, REDUCED RANGE OF MOTION AND INABILITY TO REACH FULL FLEXION DUE TO CYCLOPS LESION, THESE AFFECTIONS WERE TREATED WITH PHYSICAL THERAPY; HOWEVER, THERE WERE NOT RESOLVED. FURTHERMORE, THE PATIENT PRESENTED SIGNIFICANT SWELLING DUE TO CYCLOPS LESION, FOR WHICH AN MRI WAS PERFORMED. ASIDE FROM THE ISSUES MENTIONED, ON (B)(6) 2024, THE PATIENT HAD FIXED FLEXION DEFORMITY WITH INABILITY TO REHAB THE DEFICIT, THEREFORE, AN ARTHROSCOPY AND DEBRIDEMENT OF CYCLOPS LESION AND NOTCHPLASTY WERE PERFORMED ON (B)(6) 2024. THE PATIENT OUTCOME IS RESOLVED/RECOVERED.

  Patient problems: Loss of Range of Motion; Pain; Unspecified Musculoskeletal problem

  MAUDE report 19312498 ↗
• MalfunctionApr 12, 2024Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE WIRED FOOT PEDAL WAS NOT REGISTERING INTO THE CONSOLE EVEN THOUGH IT WAS PLUGGED IN. THE PROCEDURE WAS COMPLETED WITH A DELAY GREATER 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 19099699 ↗
• MalfunctionSep 14, 2021Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY, WHEN THE WIRELESS FOOT CONTROL WAS PRESSED TO USED THE STARVAC WAND, THE WAND DID NOT STOP BURNING WHEN THE FOOT CONTROL WAS RELEASED. THE WAND WAS NOT TOUCHING THE PATIENT'S TISSUE. IT WAS QUICKLY DISCONNECTED AND REPLACED BY HAND CONTROLLED WAND (SUPER TURBO VAC). THE PROCEDURE WAS COMPLETED WITHOUT SIGNIFICANT DELAY. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12472025 ↗
• MalfunctionMay 28, 2021No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT, THE WIRED FOOT PEDAL WAS NOT WORKING. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11905468 ↗
• MalfunctionMay 17, 2021No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT THE FOOT PEDAL WAS SCRATCHED, IT WAS NOT WORKING PROPERLY. NO CASE INVOLVED. THEREFORE, THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11838183 ↗
• MalfunctionMay 13, 2021No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT, DURING THE SET-UP OF AN UNKNOWN PROCEDURE, THE WIRED FOOT PEDAL BLUE PEDAL WAS NOT WORKING. 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 11817085 ↗
• MalfunctionMay 10, 2021Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THE WIRED FOOT PEDAL WAS NOT PROPERLY ACTIVATING WANDS WHEN PRESSED. IT IS UNKNOWN WHETHER THE EVENT HAPPENED DURING SURGERY AND IF THERE WAS PATIENT INVOLVEMENT. ALSO UNKNOWN HOW THE PROCEDURE WAS COMPLETED OR IF THERE WAS A DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11802630 ↗
• MalfunctionMay 10, 2021Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THE WIRED FOOT PEDAL WAS NOT PROPERLY ACTIVATING WANDS WHEN PRESSED. IT IS UNKNOWN WHETHER THE EVENT HAPPENED DURING SURGERY AND IF THERE WAS PATIENT INVOLVEMENT. ALSO UNKNOWN HOW THE PROCEDURE WAS COMPLETED OR IF THERE WAS A DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11802567 ↗
• MalfunctionApr 26, 2021No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT, DURING THE SET-UP OF AN UNKNOWN PROCEDURE THE WIRED FOOT PEDAL WAS NOT WORKING. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE 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 11724628 ↗
• MalfunctionApr 16, 2021Failure to Power Up; Failure to Power Up

  IT WAS REPORTED THAT DURING A SHOULDER SURGERY THE WIRED FOOT PEDAL WAS NOT WORKING. NO PATIENT INJURIES OR DELAY REPORTED. SMITH AND NEPHEW BACK-UP DEVICE WAS AVAILABLE 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 11682781 ↗
• MalfunctionApr 11, 2021No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT THE WIRED FOOT PEDAL WAS NOT WORKING WHEN PLUGGED IN. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. 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 11646815 ↗
• MalfunctionApr 8, 2021Activation Problem; Activation Problem

  IT WAS REPORTED THAT THE WIRE FOOT PEDAL WAS NOT WORKING. NO CASE 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 11633244 ↗
• MalfunctionApr 7, 2021Activation Problem; Activation Problem

  IT WAS REPORTED THAT, DURING A KNEE ARTHROSCOPY, THE WIRED FOOT PEDAL WAS NOT WORKING. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE 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 11632128 ↗
• MalfunctionApr 7, 2021Activation Problem; Activation Problem

  IT WAS REPORTED THAT, DURING A KNEE ARTHROSCOPY, THE WIRED FOOT PEDAL WAS NOT WORKING. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE 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 11632111 ↗
• MalfunctionApr 5, 2021Failure to Deliver Energy; Failure to Deliver Energy

  IT WAS REPORTED THAT THE WIRED FOOT PEDAL WAS NOT WORKING. INCIDENT OCCURRED WHILE SETTING-UP TO THE PROCEDURE. A BACK-UP DEVICE WAS AVAILABLE AND NO DELAYS 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 11614034 ↗
• MalfunctionMar 25, 2021Failure to Power Up; Failure to Power Up

  IT WAS REPORTED THAT THE WIRED FOOT PEDAL WAS NOT WORKING. NO CASE 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 11572545 ↗
• MalfunctionMar 23, 2021No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT THE WIRED FOOT PEDAL WAS NOT WORKING. NO CASE INVOLVED THEREFORE THERE WAS NO PATIENT INVOLVEMENT. 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 11555891 ↗
• MalfunctionMar 9, 2021Activation Problem; Activation Problem

  IT WAS REPORTED THAT THE WIRED FOOT PEDAL WAS NOT WORKING. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. 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 11448653 ↗
• MalfunctionFeb 15, 2021No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING THE SET UP INSPECTION, THE PEDAL WAS NOT WORKING, IT WAS UNRECOGNIZABLE IN SHAVER, IT HAD BAD PORT. BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE. NO DELAY AND NO PATIENT INJURIES WERE 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 11329863 ↗
• MalfunctionFeb 11, 2021Activation Problem; Activation Problem

  IT WAS REPORTED THAT THE WIRED FOOT PEDAL WAS NOT WORKING. IT IS UNKNOWN WHETHER THE EVENT HAPPENED DURING SURGERY AND IF THERE WAS A PATIENT INVOLVEMENT. NO FURTHER INFORMATION IS AVAILABLE. 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 11319783 ↗
• MalfunctionJan 30, 2021Failure to Deliver Energy; Failure to Deliver Energy

  IT WAS REPORTED THAT THE WIRED FOOT PEDAL WAS NOT WORKING. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. 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 11256322 ↗