VAPR 225021Recalls & reported problems
Depuy Mitek, LLC · VAPR 3 Generator REUSABLE · Class 2
All models of VAPR (30)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This VAPR generator is the power unit for a DePuy Mitek arthroscopy device. Many reports describe circuit failures, electrical faults, and error codes that stop the device from starting or working. The 157 reports include no deaths and 4 injuries. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 157
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 157 adverse event reports that list this exact device (DI 10886705009107), received between Mar 5, 2018 and Aug 26, 2026 — classified as 4 injuries, 153 malfunctions.
The most frequently reported specific device problem is “Circuit Failure” (35 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.
Reports received per month
Most reported problems
Device problems
- Circuit Failure35
- Electrical /Electronic Property Problem28
- Computer Operating System Problem20
- Image Display Error/Artifact13
- Mechanical Problem11
- Sparking10
- Output Problem9
- Corroded7
Patient problems
- No Consequences Or Impact To Patient120
- No Clinical Signs, Symptoms or Conditions32
- Not Applicable5
- Burn(s)2
- Hemorrhage/Blood Loss/Bleeding1
- No Known Impact Or Consequence To Patient1
- No Patient Involvement1
Recent adverse event reports
The 25 most recent of 157 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 26, 2026No Audible Alarm; Mechanical Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50461542 ↗MalfunctionFeb 12, 2025Mechanical Problem; Mechanical Problem
THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE OF THE ELBOW, A VAPR3 GENERATOR DEVICE AND A VAPR 3.5MM SIDE STR DEVICE WERE USED TOGETHER. ACCORDING TO THE REPORT, WHEN THE SURGEON ATTEMPTED TO USE THE VAPR 3.5MM SIDE STR DEVICE, THE VAPR3 GENERATOR DEVICE DISPLAYED THE ERROR CODE ¿200-14¿; AND THEREFORE, COULD NOT BE USED EVEN AFTER POWERING DOWN AND RESTARTING THE PRODUCT. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21363089 ↗MalfunctionSep 5, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
IT WAS REPORTED FROM CHINA THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE THE VAPR3 GENERATOR DEVICE COULD NOT CUT AND COAGULATE ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE EXACT DATE OF THIS EVENT WAS UNKNOWN BUT WAS NOTED TO HAVE OCCURRED IN (B)(6) 2024. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20148364 ↗MalfunctionSep 25, 2023Mechanical Problem; Power Problem; Mechanical Problem; Power Problem
IT WAS REPORTED BY THE AFFILIATE IN JAPAN THAT THE VAPR 3 GENERATOR DEVICE DID NOT START UP PROPERLY WHEN TURNED ON. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE DEVICE HAD AN ¿ ERROR CODE : 200 CONNECTOR/COUPLER. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17809416 ↗MalfunctionAug 29, 2023Use of Device Problem; Blocked Connection; Output Problem; Use of Device Problem; Blocked Connection; Output Problem
IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE VAPR 3 GENERATOR DEVICE WOULD NOT WORK WITH ANY FOOTSWITCH. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE DEVICE HAD INTERMITTENT OPERATION. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17643400 ↗MalfunctionJun 20, 2023Mechanical Problem; Mechanical Problem
IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT DURING A PLANNED MAINTENANCE, IT WAS OBSERVED THAT THE VAPR 3 GENERATOR DEVICE HAD AN INTERNAL ERROR 200 REFERENCE 22 UPON POWERING-UP. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17165027 ↗MalfunctionApr 6, 2023Output Problem; Output Problem
IT WAS REPORTED BY THE AFFILIATE IN GERMANY THAT DURING SERVICE AND REPAIR EVALUATION, IT WAS DETERMINED THAT THE VAPR 3 GENERATOR DEVICE HAD INTERMITTENT DISPLAY MALFUNCTION. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16691547 ↗MalfunctionApr 6, 2023Degraded; Electrical /Electronic Property Problem; Degraded; Electrical /Electronic Property Problem
IT WAS REPORTED BY THE AFFILIATE IN IRELAND THAT DURING A SERVICE AND REPAIR EVALUATION, IT WAS DETERMINED THAT THE VAPR 3 GENERATOR HAD AN ELECTRICAL ISSUE. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16691464 ↗MalfunctionMar 20, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
IT WAS REPORTED BY THE SALES REP IN CZECH REPUBLIC THAT DURING AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE COAGULATION ON THE VAPR 3 GENERATOR DEVICE DID NOT WORK. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16574401 ↗MalfunctionMar 9, 2023Device Remains Activated; Use of Device Problem; Device Remains Activated; Use of Device Problem
IT WAS REPORTED BY THE AFFILIATE IN ITALY THAT PREOPERATIVELY TO AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE VAPR 3 GENERATOR DEVICE DID NOT WORK. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE DEVICE HAD UNINTENDED ACTIVATION/MOTION. IT WAS UNKNOWN IF AND HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16512980 ↗MalfunctionFeb 9, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN FRANCE THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE VAPR 3 GENERATOR DEVICE HAD SPARKS WHILE IN USE. IT WAS UNKNOWN IF AND HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16339313 ↗MalfunctionJan 26, 2023Output Problem; Output Problem
IT WAS REPORTED BY THE AFFILIATE IN JAPAN THAT THE VAPR 3 GENERATOR DEVICE HAD AN UNSTABLE OPERATION THAT AFTER STARTUP, THE POWER WOULD GO ON AND OFF. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16249497 ↗MalfunctionJan 26, 2023Mechanical Problem; Mechanical Problem
IT WAS REPORTED BY A FIELD SERVICE ENGINEER IN CZECH REPUBLIC THAT DURING AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE VAPR 3 GENERATOR DEVICE HAD AN ERROR CODE 200 REF 12; AND THAT IT WAS UNABLE TO DRIVE SYNC SIGNAL: SHORTED HIGH. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16246504 ↗MalfunctionNov 24, 2022Mechanical Problem; Output Problem; Mechanical Problem; Output Problem
IT WAS REPORTED BY THE SALES REP THAT DURING A SHOULDER REPAIR SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT THE VAPR 3 GENERATOR DEVICE HAD AN UNSPECIFIED INTERNAL FAILURE ERROR MESSAGE. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE DEVICE HAD AN ERROR 200. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15863401 ↗MalfunctionJul 11, 2022Electrical /Electronic Property Problem; Use of Device Problem; Electrical /Electronic Property Problem; Use of Device Problem
IT WAS REPORTED BY THE DISTRIBUTOR IN BRAZIL THAT THE VAPR 3 GENERATOR DEVICE DID NOT WORK. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE DEVICE HAD AN ERROR CODE 200. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14980770 ↗MalfunctionDec 7, 2021Break; Electrical /Electronic Property Problem; Break; Electrical /Electronic Property Problem
IT WAS REPORTED THAT DURING IN-HOUSE SERVICE EVALUATION, IT WAS DETERMINED THAT THE VAPR3 GENERATOR DEVICE FAILED THE ELECTRICAL SAFETY TEST. IT WAS FURTHER DETERMINED THAT THE TOP PLATE WAS HEAVILY SCRATCHED. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12954514 ↗MalfunctionNov 29, 2021Noise, Audible; Noise, Audible
IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT THE THAT THE VAPR 3 GENERATOR DEVICE HAD AN UNUSUAL SOUND. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE DEVICE WAS PHYSICALLY BROKEN. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12887604 ↗MalfunctionNov 15, 2021Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
IT WAS REPORTED BY THE AFFILIATE IN (B)(6). THAT DURING SERVICE EVALUATION, IT WAS DETERMINED THAT THE VAPR3 GENERATOR DEVICE FAILED THE ELECTRICAL SAFETY TEST. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12814952 ↗MalfunctionOct 28, 2021Output Problem; Output Problem
IT WAS REPORTED BY THE CUSTOMER IN FRANCE THAT DURING AN UNKNOWN SURGERY ON (B)(6) 2021, IT WAS OBSERVED THAT THE VAPR3 GENERATOR DEVICE WAS BLOCKED THAT THEY HAD TO RESTART THE WHOLE SYSTEM TO MAKE IT WORK AGAIN. THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12713841 ↗MalfunctionSep 21, 2021Mechanical Problem; Mechanical Problem
IT WAS REPORTED BY THE CUSTOMER THAT THE VAPR3 GENERATOR DEVICE HAD AN ERROR CODE 200. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12509469 ↗MalfunctionAug 3, 2021Break; Break
IT WAS REPORTED BY THE CUSTOMER IN FRANCE THAT THE FRONT PANEL ON THE VAPR3 GENERATOR DEVICE GOT PHYSICALLY BROKEN AFTER A FALL. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12268884 ↗MalfunctionJun 28, 2021Output Problem; Output Problem
IT WAS REPORTED BY THE AFFILIATE IN THAT PREOPERATIVELY TO A SHOULDER ARTHROSCOPY PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE VAPR3 GENERATOR DEVICE HAD AN UNSPECIFIED INTERNAL ERROR. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE DEVICE HAD AN ERROR CODE - 200. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITHOUT DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12076966 ↗MalfunctionJun 1, 2021Mechanical Problem; Mechanical Problem
IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN ANTERIOR CRUCIATE LIGAMENT PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE VAPR3 GENERATOR DISPLAYED THE ALERT CODE 200.14. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11913358 ↗MalfunctionMay 19, 2021Output Problem; Output Problem
IT WAS REPORTED BY THE SALES REP IN (B)(6) THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE VAPR 3 GENERATOR DEVICE OCCASIONALLY HAD NO OUTPUT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11851633 ↗MalfunctionApr 26, 2021Power Problem; Power Problem
IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT PREOPERATIVELY TO AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE GENERATOR DEVICE DID NOT TURN ON. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE DEVICE HAD BROKEN CONNECTOR PIN. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11726929 ↗
Other ARTHROSCOPE devices
- FMS 283512Medos International Sàrl · ARTHROSCOPE1,800 reports
- Arthrex® AR-6480Arthrex, Inc. · ARTHROSCOPE949 reports
- FMS VUE 284002Depuy Mitek, LLC · ARTHROSCOPE829 reports
- MITEK 242018Medos International Sàrl · Arthroscope731 reports
- METRx® System 9560100Medtronic Sofamor Danek, Inc. · Arthroscope667 reports
- FMS VUE II 284004Medos International Sàrl · Arthroscope562 reports
- VAPR COOLPULSE 228146Depuy Mitek, LLC · ARTHROSCOPE474 reports
- FMS DUO 284580Depuy Mitek, LLC · ARTHROSCOPE458 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- 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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