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VAPR 225023Recalls & reported problems

Medos International Sàrl · VAPR 3 Footswitch REUSABLE · Class 2

All models of VAPR (2)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Quick summary

This Medos VAPR 3 footswitch is a foot pedal that controls electrosurgical tools in arthroscopic surgery. Many of its 286 reports describe the pedal failing to power up or stop responding, some describe it staying on after the pedal is released, and a few describe broken plugs. The reports include 4 injuries and no deaths. No recalls name this device. Reports fell from 10 in the previous 12 months to 3 in the latest 12 months.

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
286
Deaths reported
0
Injuries reported
4
Recalls naming it
0

Summary

The FDA's MAUDE database contains 286 adverse event reports that list this exact device (DI 10886705009114), received between Apr 28, 2017 and Sep 25, 2026 — classified as 4 injuries, 282 malfunctions.

The most frequently reported specific device problem is “Failure to Power Up” (40 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

Nov 2023: 1 reportsDec 2023: 1 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 2 reportsMay 2024: 0 reportsJun 2024: 1 reportsJul 2024: 2 reportsAug 2024: 3 reportsSep 2024: 3 reportsOct 2024: 4 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 3 reportsMar 2025: 1 reportsApr 2025: 1 reportsMay 2025: 1 reportsJun 2025: 2 reportsJul 2025: 1 reportsAug 2025: 1 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 1 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 1 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 1 reportsOct 2026: 0 reports2024202520264
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Failure to Power Up40
  • Electrical /Electronic Property Problem30
  • Break28
  • Output Problem28
  • Loss of or Failure to Bond26
  • Device Remains Activated23
  • Use of Device Problem21
  • Intermittent Continuity18

Patient problems

  • No Consequences Or Impact To Patient169
  • No Clinical Signs, Symptoms or Conditions100
  • Not Applicable11
  • No Patient Involvement5
  • Burn(s)4
  • No Known Impact Or Consequence To Patient2
  • No Code Available1
  • Unspecified Tissue Injury1

Recent adverse event reports

The 25 most recent of 286 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 25, 2026Output Problem

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50903720 ↗
  • MalfunctionJun 10, 2026Output Problem

    IT WAS REPORTED THAT DURING AN UNSPECIFIED ARTHROSCOPIC PROCEDURE THE VAPR3 FOOTSWITCH DEVICE STOPPED RESPONDING DURING THE SURGERY. THE SURGEON USED HAND SWITCH TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25460532 ↗
  • MalfunctionNov 20, 2025Electrical /Electronic Property Problem; Physical Resistance/Sticking; Electrical /Electronic Property Problem; Physical Resistance/Sticking

    IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE IT WAS OBSERVED THAT WHEN THE VAPR3 FOOTSWITCH EA DEVICE WAS REMOVED OUT OF THE BOX IT WAS NOTED THAT IT WAS NOT FUNCTIONING PROPERLY ¿ THE ABLATION PEDAL WAS WORKING, HOWEVER, THE COAGULATION PEDAL WAS NON-FUNCTIONAL. THERE WAS NO REPORTS OF DELAY IN THE PROCEDURE REPORTED. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23605114 ↗
  • MalfunctionAug 7, 2025Use of Device Problem; Output Problem; Use of Device Problem; Output Problem

    IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR (ARCR) SURGICAL PROCEDURE WHILE USING THE VAPR CONTROLS DEVICE, IT WAS OBSERVED THAT THE SURGEON OPENED THE BRAND-NEW ELECTRODE AND CONNECTED IT TO THE HANDPIECE PROPERLY. AFTER ABOUT AN HOUR OF USE, THE BLUE FOOTSWITCH (FOR HEMOSTASIS) SUDDENLY STOPPED WORKING EVEN THOUGH THE SURGEON STEPPED ON IT. THE YELLOW FOOTSWITCH (FOR EVAPORATION) WAS WORKING NORMALLY. THE AREA THAT NEEDED TO BE TREATED WAS SMALL, SO THE SURGEON ONLY USED THE EVAPORATION FUNCTION. THE BLUE FOOTSWITCH WAS RECONNECTED BUT THE DEVICE WAS IN USE WITH THE VAPR 3.5MM SIDE 21 DEG -EA DEVICE AND THE VAPR VUE GENERATOR DEVICE. THERE WAS A DELAY IN THE PROCEDURE OF NOT MORE THAN THIRTY MINUTES. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 1 OF 2 OF (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22738526 ↗
  • MalfunctionJul 14, 2025Break; Mechanical Problem; Material Deformation; Break; Mechanical Problem; Material Deformation

    IT WAS REPORTED THAT WHILE USING THE VAPR3 FOOTSWITCH DEVICE, WHAT LOOKS LIKE THE PART OF THE PLUG FROM THE PEDAL WAS BROKEN OFF IN THE PORT FOR THE PEDAL. SO THE PEDAL PLUG WAS BROKEN AND BENT AND THE USER COULD NOT PLUG ANOTHER PEDAL INTO THAT UNIT. THE ONLY FUNCTION NOT USABLE WAS THE PORT THE PEDAL PLUGS INTO. THERE WAS SOMETHING BLOCKING OR BENT INSIDE OF THAT PORT, I ASSUME, THAT PREVENTS ANOTHER PEDAL BEING ABLE TO PLUG IN. THE DEVICE WAS USED WITH THE VAPR VUE GENERATOR DEVICE. IT WAS UNKNOWN WHEN THE EVENT OCCURRED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE DATE OF EVENT WAS UNKNOWN BUT WAS KNOWN TO HAVE OCCURRED IN 2025. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22494989 ↗
  • MalfunctionJun 11, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

    THIS IS REPORT 1 OF 2 OF (B)(4). IT WAS REPORTED THAT WHILE USING THE VAPR3 FOOTSWITCH EA DEVICE AND THE VAPR TRIPOLAR 90 SUCTION ELECT DEVICE BOTH THE EVAPORATION AND COAGULATION FUNCTIONS WERE NOT WORKING. IT WAS UNKNOWN WHEN THE EVENT OCCURRED. THERE WAS NO REPORTS OF DELAYS IN A PROCEDURE REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE DATE OF EVENT WAS UNKNOWN BUT WAS KNOWN TO HAVE OCCURRED IN 2025. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22185436 ↗
  • MalfunctionJun 5, 2025Device Remains Activated; Device Remains Activated

    IT WAS REPORTED THAT THE VAPR3 FOOTSWITCH DEVICE CONTINUED TO OPERATE WHEN THE BLUE PEDAL WAS DEPRESSED AND RELEASED. 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 22148695 ↗
  • MalfunctionMay 29, 2025Device Remains Activated; Unintended Movement; Device Remains Activated; Unintended Movement

    IT WAS REPORTED THAT THE VAPR3 FOOTSWITCH EA DEVICE PEDAL HAD A LOOSE CONNECTION AND REMAINED ACTIVE WHEN PRESSED. IT WAS UNKNOWN WHEN THE EVENT OCCURRED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22107574 ↗
  • MalfunctionApr 24, 2025Electrical /Electronic Property Problem; Use of Device Problem; Output Problem; Electrical /Electronic Property Problem; Use of Device Problem; Output Problem

    IT WAS REPORTED THAT DURING A PASSIVE SURGICAL PROCEDURE ON THE SHOULDER WHILE USING THE VAPR3 FOOTSWITCH EA DEVICE THE VAPORIZATION SIDE OF THE PRODUCT STOPPED WORKING FOR ONE TO TWO MINUTES AFTER THE START. BECAUSE IT WAS A PASSIVE PROCEDURE ON BOTH SIDES, WHILE THE PROCEDURE WAS BEING PERFORMED ON THE RIGHT SHOULDER, THE USER TRIED TO TURN OFF AND RESTART IT BUT IT DID NOT WORK. WHEN THE PROCEDURE WAS PERFORMED ON THE OTHER SIDE, THE LEFT SHOULDER, IT ALSO WORKED FOR THE FIRST ONE TO TOW MINUTES BUT THEN IT STOPPED WORKING. SO THE REMAINING OPERATION WAS PERFORMED IN HAND MODE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21903073 ↗
  • MalfunctionMar 19, 2025Device Remains Activated; Device Remains Activated

    REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED THAT DURING AN UNKNOWN SURGICAL PROCEDURE, IT WAS OBSERVED THAT WHEN THE FOOTSWITCH BUTTON WAS NOT PRESSED, THE VAPR VUE GENERATOR DEVICE ABLATED AUTOMATICALLY. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. N O ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21641474 ↗
  • MalfunctionFeb 25, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

    IT WAS REPORTED THAT THE COAGULATION SWITCH OF THE VAPR3 FOOTSWITCH MAY HAVE BECOME UNRESPONSIVE. IT WAS NOT REPORTED IF THE EVENT OCCURRED DURING A SURGICAL PROCEDURE. IT WAS NOT REPORTED IF THERE WAS A SPARE DEVICE AVAILABLE FOR USE. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION, OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS NOT REPORTED, HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN FEBRUARY OF 2025. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21460337 ↗
  • MalfunctionFeb 20, 2025Device Remains Activated; Mechanical Jam; Device Remains Activated; Mechanical Jam

    IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT THE YELLOW PEDAL ON THE VAPR3 FOOTSWITCH DEVICE WAS STUCK DOWN AND THE ONLY WAY TO STOP THE VAPR FROM WORKING WAS TO UNPLUG THE FOOT PEDAL AND CHANGE THE CONSOLE TO FOOT CONTROL. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT, OR SURGICAL DELAY. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21425370 ↗
  • MalfunctionFeb 8, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

    IT WAS REPORTED THAT DURING A KNEE SYNOVECTOMY PROCEDURE FOR KNEE SYNOVITIS IT WAS OBSERVED THAT THE VAPR3 FOOTSWITCH DID NOT OPERATE FOR COAGULATION. IT WAS REPORTED THAT THE COAGULATION DID NOT WORK. IT WAS REPORTED THAT THE DEVICE CONNECTION WAS PLUGGED AND UNPLUGGED TO THE MAIN UNIT, BUT THE SITUATION DID NOT CHANGE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT, OR SURGICAL DELAY. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21340389 ↗
  • MalfunctionOct 22, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

    IT WAS REPORTED BY THE SALES REP THAT THE VAPR3 FOOTSWITCH DEVICE POWER CORD SHORTED OUT. ACCORDING TO THE REPORTER, THE DEVICE WAS IN THE WAREHOUSE. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20504277 ↗
  • MalfunctionOct 11, 2024Mechanical Jam; Physical Resistance/Sticking; Mechanical Jam; Physical Resistance/Sticking

    IT WAS REPORTED BY SALES REP VIA EMAIL THAT BEFORE SHOULDER SCOPE PROCEDURE VAPR 3 FOOTSWITCH HAS THE BUTTON ON THE BLACK MODE PEDAL WAS GETTING STUCK. A DIFFERENT FOOTSWITCH WAS USED TO COMPLETE THE CASE. 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 20428279 ↗
  • MalfunctionOct 10, 2024Device Remains Activated; Mechanical Jam; Device Remains Activated; Mechanical Jam

    WHEN USING THE VAPR FOOT PEDAL, IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, A VAPR3 FOOTSWITCH DEVICE WAS USED. ACCORDING TO THE REPORT, THE PEDAL GOT STUCK WHEN FOOT WAS LIFTED; AND THAT VAPR CONTINUED TO OPERATE WHILE BEING REMOVED FROM THE JOINT. 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 20420845 ↗
  • MalfunctionOct 2, 2024Device Remains Activated; Mechanical Jam; Device Remains Activated; Mechanical Jam

    IT WAS REPORTED BY SALES REP VIA EMAIL THAT DURING SHOULDER ARTHROSCOPY PROCEDURE VAPR 3 FOOTSWITCH WAS JAMMED AND THE ABLATION WAND CONTINUED TO BURN DURING THE CASE. WE HAD TO USE ANOTHER PEDAL TO FINISH THE CASE.. NO SURGICAL DELAY OR PATIENT HARM. DEVICE IS AVAILABLE FOR EVALUATION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20353342 ↗
  • MalfunctionSep 20, 2024Electrical /Electronic Property Problem; Use of Device Problem; Electrical /Electronic Property Problem; Use of Device Problem

    IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT THE COAGULATION PEDAL OF THE VAPR3 FOOTSWITCH DEVICE WAS NOT WORKING. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO SURGICAL DELAY OR ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20272002 ↗
  • MalfunctionSep 16, 2024Device Remains Activated; Mechanical Jam; Device Remains Activated; Mechanical Jam

    IT WAS REPORTED BY THE SALES REP THAT DURING A SHOULDER ARTHROSCOPY SURGICAL PROCEDURE ON (B)(6) 2024 THE VAPR3 FOOTSWITCH EA DEVICE FOOTSWITCH WAS JAMMED AND THE ABLATION WAND CONTINUED TO BURN. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. 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 20224353 ↗
  • MalfunctionSep 16, 2024Break; Break

    IT WAS REPORTED FROM THE SALES REP THAT PRIOR TO AN ARTHROSCOPIC SHOULDER STABILIZING SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE VAPR3 FOOTSWITCH EA DEVICE FOOT PEDAL CONNECTION POINT WAS BROKEN. THIS EVENT DID NOT OCCUR DURING SURGERY. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20224267 ↗
  • MalfunctionAug 28, 2024Device Remains Activated; Use of Device Problem; Output Problem; Device Remains Activated; Use of Device Problem; Output Problem

    IT WAS REPORTED THAT PRIOR TO A DURING A SHOULDER STEREO ARTHROLYSIS ON SHOULDER JOINT TREATING FOR FROZEN SHOULDER PROCEDURE THE VAPR3 FOOTSWITCH DEVICE HAD AN ERROR SOUND THAT WAS HEARD WHEN VAPR VUE WAS STARTED USING THE SAME PROCEDURE AS USUAL. THE ERROR CODE WAS 400-19. THEN, THE SALES REP TRIED TURNING IT OFF AND STARTING IT UP AGAIN, UNPLUGGING THE FOOT SWITCH IN QUESTION AND STARTING IT UP AGAIN. IT WAS OBSERVED THAT WHEN IT WAS PLUGGED IN, SOMETIMES THE LIGHT WAS NOT GLOWING. ALSO, SOMETIMES ¿ADVANCED¿ OR ¿ENGLISH¿ WAS DISPLAYED ON THE MAIN UNIT SIDE EVEN THOUGH THE FOOT SWITCH WAS NOT STEPPED ON. THERE WAS A 30 MINUTE 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 20085206 ↗
  • MalfunctionAug 27, 2024Output Problem; Output Problem

    IT WAS REPORTED BY THE SALES REP THAT DURING SHOULDER ARTHROSCOPY PROCEDURE ON (B)(6) 2024 IT WAS OBSERVED THAT THE VAPR 3 FOOTSWITCH DEVICE WORKED INTERMITTENTLY WHEN IT WAS PRESSED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH AN UNSPECIFIED SLIGHT DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20074422 ↗
  • MalfunctionAug 6, 2024Device Remains Activated; Physical Resistance/Sticking; Device Remains Activated; Physical Resistance/Sticking

    IT WAS REPORTED BY THE SALES REP IN AUSTRALIA THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE ON (B)(6) 2024 THE VAPR3 FOOTSWITCH EA DEVICE STICKS DOWN MAKING IT UNSAFE TO USE AS THE VAPR WONT STOP. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO DELAY TO THE SURGICAL PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19918966 ↗
  • MalfunctionJul 22, 2024Electrical /Electronic Property Problem; Physical Resistance/Sticking; Electrical /Electronic Property Problem; Physical Resistance/Sticking

    IT WAS REPORTED BY THE AFFILIATE IN JAPAN THAT ON AN UNKNOWN DATE THE VAPR 3 FOOTSWITCH DEVICE COAG BUTTON DID NOT WORK. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19792181 ↗
  • MalfunctionJul 11, 2024Device Remains Activated; Device Remains Activated

    REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED BY THE AFFILIATE IN JAPAN THAT THE VAPR3 FOOTSWITCH *EA DEVICE FOOT SWITCH (BLUE) WOULD TURN ON EVEN WHEN THE USER WAS NOT STEPPING ON THE SWITCH AND WOULD NOT STOP MOVING WHILE IN USE WITH THE VAPR VUE GENERATOR DEVICE. 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 19718079 ↗

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