VAPR 225312Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886705009312), received between Sep 18, 2018 and May 4, 2022 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 4, 2022Electrical /Electronic Property Problem; Use of Device Problem; Electrical /Electronic Property Problem; Use of Device Problem

  IT WAS REPORTED BY THE CUSTOMER IN (B)(6) THAT DURING AN ARTHROSCOPIC SHOULDER STABILIZATION SURGERY ON (B)(6) 2021, IT WAS OBSERVED THAT THE VAPR 3.5MM FLEX SIDE DEVICE DID NOT WORK AND EVEN AFTER THE CABLE WAS CHANGED, IT STILL DID NOT WORK. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THERE WAS POOR ACTIVE SOLDER CONNECTION AND GAP BETWEEN SOLDER AND PCB ON THE DEVICE WHICH FURTHER SHOWED THAT THE DEVICE HAD AN ELECTRICAL PROBLEM; AND THAT IT DID NOT COAGULATE NOR ABLATE. 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 14278750 ↗
• MalfunctionMay 4, 2022Electrical /Electronic Property Problem; Appropriate Device Problem Term/Code Not Available; Electrical /Electronic Property Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE CUSTOMER IN (B)(6) THAT DURING AN ARTHROSCOPIC SHOULDER STABILIZATION SURGERY ON (B)(6) 2021, IT WAS OBSERVED THAT THE VAPR 3.5MM FLEX SIDE DEVICE DID NOT WORK AND EVEN AFTER THE CABLE WAS CHANGED, IT STILL DID NOT WORK. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THERE WAS POOR ACTIVE SOLDER CONNECTION AND GAP BETWEEN SOLDER AND PCB ON THE DEVICE WHICH FURTHER SHOWED THAT THE DEVICE HAD AN ELECTRICAL PROBLEM; AND THAT IT DID NOT COAGULATE NOR ABLATE. 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 14278702 ↗
• MalfunctionJul 14, 2020Device Damaged Prior to Use; Device Damaged Prior to Use

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN UNKNOWN SURGERY, IT WAS OBSERVED THAT THE ELECTRODE DEVICE WAS DAMAGED UPON OPENING ITS PACKAGE. IT WAS NOT REPORTED IF THERE WAS A DELAY IN THE SURGERY OR IF A SPARE DEVICE WAS AVAILABLE FOR USE TO COMPLETE THE SURGERY. 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 WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10270096 ↗
• MalfunctionMar 23, 2020Break; Break

  IT WAS REPORTED BY AFFILIATE VIA EMAIL THAT DURING SHOULDER REPAIR THE VAPR 3.5MM FLEX SIDE -EA THE TIP OF THE ELECTRODE WAS BROKEN IN THE MIDDLE OF SURGERY. NO PATIENT CONSEQUENCES OR SURGICAL DELAY REPORTED. THE DEVICE IS AVAILABLE TO BE RETURNED FOR EVALUATION. THE AFFILIATE ALSO REPORTED ALL FRAGMENTS WERE REMOVED FROM THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9865939 ↗
• MalfunctionSep 18, 2018Electromagnetic Interference; Electromagnetic Interference

  IT WAS REPORTED THE ELECTRODE CAUSED DISTURBANCES IN THE VIO 3- ERBE DEVICE WHEN USED NORMALLY. THE VIO 3- ERBE STOOD ON THE TOWER BUT WAS NOT IN USE. ONLY THE NEUTRAL ELECTRODE WAS ATTACHED TO THE PATIENT. DURING THE USE OF THE VAPR THE VIO 3 JUMPED THROUGH ITS PROGRAM, INDICATING A FAILURE BY THE VAPR. CUSTOMER HAD PURCHASED 2 OTHER ELECTRODES WITH THE SAME BATCH, WHICH DID NOT WORK WHICH IS CAPTURED IN COMPLAINT 15126MT. THE CUSTOMER HAS ELEVEN (11) MORE UNOPENED ELECTRODES FROM THE SAME BATCH WHICH WILL BE RETURNED. NEW ELECTRODES WILL BE PURCHASED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7885009 ↗