Quantum 2Recalls & reported problems across all models
Smith & Nephew, Inc. · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 61
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls
- 0
We found 2 models of Quantum 2 by Smith & Nephew, Inc. in the FDA's device registry (GUDID). Together they are named in 61 adverse event reports in the FDA's MAUDE database, received between Nov 13, 2018 and Aug 7, 2025 — classified as 5 injuries, 56 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Quantum 2 problems
Device problems
- Electrical /Electronic Property Problem18
- Energy Output Problem16
- Device Alarm System4
- Smoking4
- Communication or Transmission Problem3
- No Apparent Adverse Event3
- Protective Measures Problem3
- Device Displays Incorrect Message2
Patient problems
- No Clinical Signs, Symptoms or Conditions53
- No Known Impact Or Consequence To Patient5
- Insufficient Information3
- No Consequences Or Impact To Patient1
- No Patient Involvement1
Quantum 2 models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Quantum 2 H4500-00Electrosurgical, cutting & coagulation & accessories60 reports
- QUANTUM 2 28168-59Electrosurgical, cutting & coagulation & accessories1 report
Recent Quantum 2 adverse event reports
The 15 most recent reports across all models, 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 ↗
Other Smith & Nephew, Inc. products
- FAST-FIX18 models · 9,554 reports
- JOURNEY566 models · 6,250 reports · 4 recalls
- GENESIS II462 models · 4,599 reports · 2 recalls
- DYONICS, POWERMAX, ELITE2 models · 4,308 reports
- TRIGEN381 models · 3,599 reports · 5 recalls
- LEGION446 models · 2,039 reports · 4 recalls
- REAL INTELLIGENCE32 models · 2,017 reports · 3 recalls
- Coblation62 models · 2,126 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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