Quantum 2 H4500-00Recalls & reported problems

Summary

The FDA's MAUDE database contains 60 adverse event reports that list this exact device (DI 00817470001891), received between Nov 13, 2018 and Aug 7, 2025 — classified as 5 injuries, 55 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (18 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 25 most recent of 60 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 7, 2025Energy Output Problem; Energy Output Problem

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE QUANTUM 2 CONTROLLER HAD AN F4 ERROR. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A SURGICAL 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 22738741 ↗
• MalfunctionApr 24, 2025Energy Output Problem; Energy Output Problem

  IT WAS REPORTED THAT, DURING SURGERY, THE QUANTUM 2 CONTROLLER DISPLAYED "HARDWARE FAILED". SURGERY WAS COMPLETED WITH A COMPETITOR DEVICE, INSTEAD. THERE WAS A DELAY GREATER THAN 30 MINUTES, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21905673 ↗
• MalfunctionMar 17, 2025Energy Output Problem; Energy Output Problem

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE, THE FA QUANTUM CONTROLLER HAD AN F4 ERROR. THE PROCEDURE WAS COMPLETED WITH A 40 MINUTES DELAY USING A COMPETITOR DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21627760 ↗
• MalfunctionMar 12, 2025Energy Output Problem; Energy Output Problem

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY PROCEDURE, THE QUANTUM 2 CONTROLLER DISPLAYED AN "F4 HARDWARE FAILURE" ERROR CODE, WHICH RESULTED IN THE WASTAGE OF THE WAND DUE TO THIS FAILURE. THE PROCEDURE WAS COMPLETED USING A DIFFERENT SURGICAL TECHNIQUE. THERE WAS A DELAY OF 31 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21586174 ↗
• MalfunctionMar 6, 2025Device Alarm System; Device Alarm System

  IT WAS REPORTED THAT DURING SURGERY, THE QUANTUM 2 CONTROLLER WOULD NOT STOP ALARMING, WITH NO ERROR CODE OR MESSAGE DISPLAYED ON THE CONTROLLER'S SCREEN. THE PROCEDURE WAS COMPLETED WITH A SURGICAL 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 21533571 ↗
• InjuryMar 3, 2025Electrical /Electronic Property Problem; Energy Output Problem; Electrical /Electronic Property Problem; Energy Output Problem

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY, THE FA QUANTUM 2 CONTROLLER HAD A F4 ERROR. THE PROCEDURE WAS CHANGED TO AN OPEN PROCEDURE, AND THERE WAS A NON-SIGNIFICANT SURGICAL DELAY REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21509545 ↗
• InjuryFeb 26, 2025Energy Output Problem; Energy Output Problem

  IT WAS REPORTED THAT DURING A PROCEDURE, AN F4 ERROR OCCURRED WITH THE QUANTUM 2 CONTROLLER. THE PROCEDURE WAS SWITCHED TO OPEN SURGERY. THERE WAS NO SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21468884 ↗
• MalfunctionFeb 24, 2025Overheating of Device; Smoking; Overheating of Device; Smoking

  IT WAS REPORTED THAT THE QUANTUM 2 CONTROLLER WAS SHOWING AN F4 ERROR MESSAGE, AND IT WAS ON FIRE, SMOKING, AND EMITTING A BAD SMELL. IT IS UNKNOWN WHETHER THE EVENT OCCURRED DURING SURGERY, IF THERE WAS PATIENT INVOLVEMENT, OR IF A BACK-UP DEVICE WAS AVAILABLE. THERE WAS NO SURGICAL DELAY, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21445815 ↗
• MalfunctionFeb 6, 2025Energy Output Problem; Energy Output Problem

  IT WAS REPORTED THAT, DURING AN UNSPECIFIED PROCEDURE, THE FA QUANTUM 2 CONTROLLER HAD A F4 ERROR. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE INSTEAD. THERE WAS A SURGICAL DELAY OF TWO HOURS. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21322148 ↗
• MalfunctionJan 3, 2025Device Alarm System; Energy Output Problem; Device Alarm System; Energy Output Problem

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE QUANTUM II CONTROLLER STOPPED WORKING, IT WAS BEEPING AND IT WAS DISPLAYING AN F4 ERROR MESSAGE. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. THERE WAS A SURGICAL DELAY OF 1 HOUR AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21067232 ↗
• MalfunctionNov 1, 2024Energy Output Problem; Insufficient Device Problem Information; Energy Output Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE QUANTUM 2 CONTROLLER WAS SHOWING A WAND ERROR DESPITE OF USING A NEW WAND TWICE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A SURGICAL DELAY GREATER THAN 30 MINUTES USING A DIFFERENT TECHNIQUE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20589564 ↗
• MalfunctionOct 1, 2024Energy Output Problem; Energy Output Problem

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, AN F4 ERROR (HARDWARE PROBLEM) WAS DISPLAYED ON THE SCREEN OF THE QUANTUM 2 CONTROLLER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A SURGICAL 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 20344897 ↗
• MalfunctionSep 16, 2024Energy Output Problem; Energy Output Problem

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY, THE FA QUANTUM II CONTROLLER DISPLAYED AN F4 ERROR. THE PROCEDURE WAS COMPLETED WITH THE SHAVER TOOL. THERE WAS A DELAY GREATER THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20230904 ↗
• MalfunctionAug 23, 2024Energy Output Problem; Energy Output Problem

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY, THE QUANTUM 2 CONTROLLER HAD AN F4 ERROR. THE PROCEDURE WAS COMPLETED WITH A COMPETITOR 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 20055516 ↗
• MalfunctionAug 22, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT DURING A SHOULDER INSTABILITY PROCEDURE, THE QUANTUM 2 CONTROLLER HAD AN F4 HARDWARE FAILURE. THE PATIENT WAS ALREADY ANESTHETIZED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A SURGICAL 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 20025817 ↗
• MalfunctionAug 21, 2024Energy Output Problem; Energy Output Problem

  IT WAS REPORTED THAT DURING A HIP PROCEDURE, THE QUANTUM 2 CONTROLLER HAD A F4 FAILURE. IT WAS REPORTED THAT A BACK UP DEVICE WAS USED, AND THERE WAS A SURGICAL DELAY GREATER THAN 30 MINUTES, HOWEVER, SURGERY WAS CANCELLED.

  Patient problems: Insufficient Information

  MAUDE report 20023441 ↗
• MalfunctionAug 21, 2024Energy Output Problem; Energy Output Problem

  IT WAS REPORTED THAT, DURING A SHOULDER PROCEDURE THE QUANTUM 2 CONTROLLER HAD AN F4 FAILURE. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE INSTEAD. 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 20022537 ↗
• MalfunctionAug 21, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT DURING A LIGAMENT PROCEDURE, THE QUANTUM 2 CONTROLLER HAD AN F4 HARDWARE FAILURE. THE PATIENT WAS ALREADY ANESTHETIZED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A SURGICAL 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 20022213 ↗
• MalfunctionAug 7, 2024Device Alarm System; Failure to Power Up; Device Alarm System; Failure to Power Up

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, THE QUANTUM 2 CONTROLLER WAS NOT GETTING ON, AND IT WAS MAKING BEEP SOUNDS WITH ERROR. SURGERY WAS COMPLETED WITH A COMPETITOR DEVICE INSTEAD. 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 19933347 ↗
• MalfunctionAug 6, 2024Failure to Conduct; Failure to Conduct

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE QUANTUM 2 CONTROLLER DISPLAYED AN ERROR E8. THE PROCEDURE WAS FINISHED WITH A COMPETITOR DEVICE. 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 19917979 ↗
• MalfunctionAug 5, 2024Energy Output Problem; Energy Output Problem

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE QUANTUM 2 CONTROLLER HAD AN F4 ERROR. THERE WAS A SURGICAL DELAY GREATER THAN 30 MINUTES, AND THE PROCEDURE WAS COMPLETED WITH A J&J - VAPR COMPETITOR DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19906113 ↗
• MalfunctionJul 11, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE FA QUANTUM CONTROLLER WAS NOT WORKING, IT HAD A CONNECT WAND ERROR. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A SURGICAL 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 19721835 ↗
• MalfunctionJul 3, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE QUANTUM II CONTROLLER HAD A F4 HARDWARE FAILURE. THE PROCEDURE WAS COMPLETED WITH A SURGICAL DELAY GREATER THAN 30 MINUTES USING A COMPETITOR DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19667587 ↗
• MalfunctionMay 20, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE QUANTUM II CONTROLLER HAD AN F4 ERROR MESSAGE. THERE WAS A J&J VAPR COMPETITOR DEVICE AVAILABLE AND A DELAY GREATER THAN 30 MINUTES WAS REPORTED. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19351879 ↗
• MalfunctionFeb 20, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE QUANTUM II CONTROLLER INITIALLY HAD AN F6 ERROR AND THEN IT REPORTED AN ERROR: F4: HARDWARE FAILURE. THE PROCEDURE WAS COMPLETED WITH A CHANGE IN THE SURGICAL TECHNIQUE OF AN ACL RECONSTRUCTION. THERE WAS A DELAY GREATER THAN 30 MINUTES. NO PATIENT INVOLVEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18744277 ↗