VAPR 225302Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10886705009268), received between Jul 26, 2018 and Aug 7, 2025 — classified as 1 injury, 15 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (4 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 7, 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 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 VAPR HANDPIECE EA DEVICE PROPERLY. AFTER ABOUT AN HOUR OF USE, THE BLUE VAPR3 FOOTSWITCH *EA (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 CONDITION DID NOT CHANGE, AND THE BLUE FOOTSWITCH DID NOT WORK. THERE WERE NO ¿ERROR¿ OR ¿FAULT¿ MESSAGES ON THE SCREEN. THERE WERE 3X VAPR HANDPIECE EA DEVICES, A VAPR 3.5MM SIDE 21 DEG -EA DEVICE, A VAPR3 FOOTSWITCH *EA DEVICE AND A VAPR VUE GENERATOR DEVICE USED IN THE PROCEDURE. 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 2 OF 6 OF (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22738525 ↗
• MalfunctionJun 16, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR (ARCR) SURGICAL PROCEDURE WHILE USING THE VAPR 3.5MM SIDE 21 DEG -EA DEVICE FOR A ROTATOR CUFF TEAR, AN ELECTRODE WAS OPENED AND CONNECTED PROPERLY, THE DISPLAY SHOWED THE NORMAL DEFAULT SETTINGS. FROM THE BEGINNING OF THE SURGERY, THE SURGEON USED THE ELECTRODE BY FOOTSWITCH FOR EVAPORATION AND HEMOSTASIS. HOWEVER, THE SURGEON SAID THAT ALTHOUGH THE MAIN BODY MADE OPERATION NOISE DURING BOTH THE EVAPORATION AND HEMOSTASIS PROCESSES, THE BURNING FUNCTION DID NOT WORK AT ALL. CONSIDERING THE POSSIBILITY OF A MALFUNCTION IN THE HANDPIECE, A DIFFERENT STERILIZED HANDPIECE WAS CONNECTED, BUT THE SITUATION DID NOT CHANGE. THEREFORE, ANOTHER NEW ELECTRODE WAS CONNECTED, AND THEN, THAT NEW ELECTRODE FUNCTIONED NORMALLY. THERE WAS A THIRTY MINUTE 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 22215145 ↗
• MalfunctionMay 5, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS FOUND THAT THE PLASTIC TIP OF THE VAPR 3.5 MM SIDE 21 DEG -EA DEVICE CAME OFF. THE SALES REPRESENTATIVE WAS UNABLE TO FIND ANY TRACES OF IT. THERE WERE NO DELAYS TO THE SURGICAL PROCEDURE. IT WAS NOT REPORTED IF A SPARE DEVICE WAS AVAILABLE FOR USE. 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 21960746 ↗
• MalfunctionMar 25, 2024Degraded; Device Contaminated During Manufacture or Shipping; Degraded; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED BY THE SALES REP FROM JAPAN THAT PRIOR TO A ROTATOR CUFF REPAIR SURGERY, IT WAS DISCOVERED THAT THE VAPR ANGLED SIDE EFFECT ELECTRODE 3.5 MM X 160 MM DEVICE HAD RUST ON THE TIP OF THE ELECTRODE. IT WAS REPORTED THAT THE DEVICE WAS BRAND NEW. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE DEVICE HAD FOREIGN SUBSTANCE/DEBRIS/CLEANING/STERILIZATION. IT WAS REPORTED THAT THERE WERE NO DELAYS TO THE SURGICAL PROCEDURE AS A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18968398 ↗
• MalfunctionMar 14, 2024Electrical /Electronic Property Problem; Output Problem; Electrical /Electronic Property Problem; Output Problem

  IT WAS REPORTED BY THE AFFILIATE IN JAPAN THAT DURING A ARTHROSCOPIC ROTATOR CUFF REPAIR FOR A ROTATOR CUFF TEAR PROCEDURE, IT WAS OBSERVED THAT ALTHOUGH THE ELECTRODE ON THE VAPR ANGLED SIDE EFFECT ELECTRODE 3.5 MM X 160 MM DEVICE WAS CONNECTED TO A HANDPIECE DEVICE WITH THE PROPER ORDER AND METHOD, AN ERROR MESSAGE ¿INSERT ELECTRODE¿ WAS SHOWN, AND THE ELECTRODE WAS NOT ABLE TO BE USED. WHEN ANOTHER PROBE WAS CONNECTED TO THE HANDPIECE, THE PROBE WORKED AS EXPECTED. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE DEVICE WOULD NOT COAGULATE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH A 30-MINUTE DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18905781 ↗
• MalfunctionDec 13, 2023Break; Use of Device Problem; Break; Use of Device Problem

  IT WAS REPORTED BY THE AFFILIATE IN JAPAN THAT PRIOR TO AN ARTHROSCOPY ROTATOR CUFF REPAIR PROCEDURE FOR ROTATOR CUFF TEAR ON (B)(6) 2023, IT WAS OBSERVED THAT THE VAPR 3.5MM SIDE 21 DEG DEVICE DID NOT WORK WHEN IT WAS ATTACHED. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE DEVICE HAD A BREAK ALONG THE SHAFT CAUSED BY A CUT WIRE JUST BEFORE ENTERING IN THE RETURN TUBE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THE DEVICE WAS BRAND NEW AND THE FIRST USE WHEN THE ISSUE OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18316609 ↗
• MalfunctionJul 31, 2023Output Problem; Output Problem

  IT WAS REPORTED BY THE AFFILIATE IN JAPAN THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE ANGLED SIDE EFFECT ELECTRODE, 21º DEVICE WAS NOT ENERGIZED FREQUENTLY AND STOPPED WORKING. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY WITHIN 30 MINUTES DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17427401 ↗
• MalfunctionMay 22, 2023Use of Device Problem; Blocked Connection; Use of Device Problem; Blocked Connection

  IT WAS REPORTED BY THE AFFILIATE IN JAPAN THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE ANGLED SIDE EFFECT ELECTRODE, 21º DEVICE WAS NOT RECOGNIZED ALTHOUGH IT WAS ATTACHED TO THE HANDPIECE. 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 16976922 ↗
• MalfunctionNov 24, 2022Device Damaged Prior to Use; Device Damaged Prior to Use

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN UNKNOWN SURGERY ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE COIL ON THE MOST SHAFT SIDE ON THE ANGLED SIDE EFFECT ELECTRODE, 21º DEVICE WAS FLOATING AND ABOUT TO COME OFF WHEN THE DEVICE WAS OPENED. ACCORDING TO THE REPORT, ALTHOUGH IT SEEMED POSSIBLE TO USE THE DEVICE, THE SURGEON JUDGED THAT IT WOULD BE A PROBLEM IF THE COIL FELL IN THE PATIENT¿S BODY, AND THEREFORE THE DEVICE WAS NOT USED. 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 15862891 ↗
• MalfunctionJun 29, 2022Electrical /Electronic Property Problem; Device Contamination with Body Fluid; Power Problem; Electrical /Electronic Property Problem; Device Contamination with Body Fluid; Power Problem

  IT WAS REPORTED BY THE AFFILIATE IN JAPAN THAT DURING AN UNKNOWN PROCEDURE (B)(6) 2022, IT WAS OBSERVED THAT THE ANGLED SIDE EFFECT ELECTRODE, 21º DEVICE DID NOT START WHEN IT WAS SWITCHED ON. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE DEVICE HAD TISSUE DEBRIS VISIBLE AT ITS DISTAL END AND FAILED THE COAGULATION TESTING. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THE DEVICE WAS BRAND NEW AND THE FIRST USE WHEN THE ISSUE OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14853295 ↗
• InjuryMay 9, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT POSTOPERATIVELY TO AN ARTHROSCOPIC ROTATOR CUFF REPAIR SURGERY ON (B)(6) 2022 USING A VAPR 3.5MM SIDE 21 DEG DEVICE, THE PATIENT WAS X-RAYED WHEN IT WAS LOCATED A METAL-LIKE SUBSTANCE (APPROXIMATELY 2 TO 3 MM LARGE) INSIDE THE DELTOID. ACCORDING TO THE REPORT, IT WAS CONFIRMED THAT A PART OF THE ELECTRODE¿S COIL HAD CHIPPED. IT WAS FURTHER REPORTED THAT THE SURGEON CONCLUDED THAT THE CHIPPED FRAGMENT IN THE LESION WAS LIKELY TO COME FROM THE ELECTRODE IN QUESTION. THE STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 14337350 ↗
• MalfunctionDec 8, 2020Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR PROCEDURE WHILE TREATING ROTATOR CUFF TEAR ON (B)(6) 2020. IT WAS OBSERVED THAT THE VAPR 3.5 MM SIDE 21 DEG DEVICE THAT A BLOOD-LIKE STAIN HAD BEEN ON THE ELECTRODE. NO PRODUCT DEFECTIVENESS WAS REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10971219 ↗
• MalfunctionSep 18, 2020Blocked Connection; Blocked Connection

  IT WAS REPORTED THAT THIS WAS AN UNKNOWN PROCEDURE PERFORMED ON (B)(6) 2020. PREOPERATIVELY THE HANDPIECE WAS CONNECTED TO THE MAIN UNIT WHICH SHOWED ¿INSERT ELECTRODE.¿ THE HANDPIECE WAS REPLUGGED IN SEVERAL TIMES, WHICH DID NOT CORRECT THE ISSUE. THE PROCEDURE WAS COMPLETED WITH A REPLACEMENT WITHOUT SURGICAL DELAY. THERE WAS NO SURGICAL DELAY AND NO HARM TO THE PATIENT. THE DEVICE WAS THE FIRST USE WHEN THE ISSUE OCCURRED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10557542 ↗
• MalfunctionSep 3, 2020Residue After Decontamination; Residue After Decontamination

  THIS IS REPORT 2 OF 2 FOR THE SAME EVENT. IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN UNKNOWN PROCEDURE, IT WAS OBSERVED THAT THE ABLATION FEATURE ON THE ELECTRODE DEVICE DID NOT WORK. THE PROCEDURE WAS COMPLETED LESS THAN 30-MINUTE SURGICAL DELAY. THERE WAS NO HARM TO THE PATIENT. THE DEVICE WAS THE FIRST USE WHEN THE ISSUE OCCURRED. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE DEVICE SHOWED EVIDENCE OF ACTIVATION WITH TISSUE DEBRIS BEING VISIBLE AT TIP. THERE WERE NO PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: Not Applicable

  MAUDE report 10489906 ↗
• MalfunctionSep 3, 2020Residue After Decontamination; Residue After Decontamination

  THIS IS REPORT 1 OF 2 FOR THE SAME EVENT. IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN UNKNOWN PROCEDURE, IT WAS OBSERVED THAT THE ABLATION FEATURE ON THE ELECTRODE DEVICE DID NOT WORK. THE PROCEDURE WAS COMPLETED LESS THAN 30-MINUTE SURGICAL DELAY. THERE WAS NO HARM TO THE PATIENT. THE DEVICE WAS THE FIRST USE WHEN THE ISSUE OCCURRED. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE DEVICE SHOWED EVIDENCE OF ACTIVATION WITH TISSUE DEBRIS BEING VISIBLE AT TIP. THERE WERE NO PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Patient Involvement; Not Applicable

  MAUDE report 10489883 ↗
• MalfunctionJul 26, 2018Suction Failure; Suction Failure

  SHOULDER ARTHROSCOPY. NURSE REPORTED THERE WERE TWO VAPR TRIPOLAR ELECTRODES WHICH WERE BLOCKED DURING USE AND ANOTHER HAD TO BE OPENED. BOTH CASES HAPPENED AT START OF CASE - WITHIN THE FIRST 5 -10 MINUTES OF USE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7721826 ↗