VAPR 227301Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10886705009671), received between Dec 10, 2018 and Oct 26, 2022 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Device Damaged Prior to Use” (2 reports).

2 other recalls cover devices cleared under the same FDA submission (K082643); they may or may not involve this specific model.

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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 26, 2022Electrical /Electronic Property Problem; Use of Device Problem; Electrical /Electronic Property Problem; Use of Device Problem

  THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED BY THE DISTRIBUTOR IN SLOVAKIA THAT DURING A KNEE ARTHROSCOPY PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE VAPR SIDE EFFECT ELECTRODE 3.5MM, SIDE EFFECT W/INTEGRATED HANDPIECE DEVICE DID NOT WORK. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE DISTAL TIP ON THE DEVICE SHOWED NO OBVIOUS SIGNS OF ACTIVATION, ELECTRICAL TESTING REVEALED THAT THE CAPACITANCE VALUE WAS SLIGHTLY ABOVE TOP SPECIFICATION VALUE, AND WHEN CONNECTED TO A GENERATOR THE DISPLAY VARIED BETWEEN CORRECT SETTINGS, INVALID INSTRUMENT AND INCORRECT DEFAULT SETTINGS. 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 15674842 ↗
• MalfunctionJan 12, 2021Output Problem; Output Problem

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT PREOPERATIVELY TO AN ARTHROSCOPY PROCEDURE ON (B)(6) 2020, IT WAS OBSERVED THAT AN ELECTRODE DEVICE PROMPTED AN UNSPECIFIED ALERT MESSAGE ON THE GENERATOR. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THERE WERE TISSUE DEBRIS BEING VISIBLE AROUND THE TIP ON THE ELECTRODE DEVICE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH A THREE MINUTE DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11154320 ↗
• MalfunctionDec 3, 2020Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED BY THE SALES REP THAT DURING A ROTATOR CUFF REPAIR ON (B)(6) 2020, IT WAS OBSERVED THAT THE VAPR SIDE EFFECT ELECTRODE 3.5MM, SIDE EFFECT W/INTEGRATED HANDPIECE SHORTED. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT CONSEQUENCES OR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10941548 ↗
• MalfunctionApr 29, 2020Device Damaged Prior to Use; Device Damaged Prior to Use

  IT WAS REPORTED BY AFFILIATE VIA EMAIL THE VAPR3.5MM SIDEEFFECT 1-PCE ELECTRODE-EA, IMPLANT IS REQUESTED AND IT IS OPENED PROPERLY, THE ENVELOPE WHERE THE VAPR SIDE EFFECT ELECTRODE COMES FROM IS CAREFULLY OPENED SO THAT THE SURGICAL NURSE COULD TAKE THE AFOREMENTIONED MATERIAL, REFERENCE (B)(4), AFTER WHICH IT IS CONNECTED TO THE VAPR CONSOLE AND WE BECAME AWARE OF BOTH THE JOHNSON TECHNICIAN (B)(6) AND I, WHO REPORTED AN ERROR IN THE CONSOLE WHEN CONNECTING THE HANDPIECE, WE PROCEEDED TO CHANGE THE TRADITIONAL CONSOLE TO A VAPR VUE CONSOLE TO VERIFY IF THE PROBLEM WAS THE CONSOLE, BUT IT WAS NOT; SINCE THE ELECTRODE FAILED AGAIN, SO WE PROCEEDED TO OPEN ANOTHER VAPR TIP 227301 BY CONNECTING IT TO THE VAPR VUE CONSOLE WHERE IT WORKED WITHOUT ANY PROBLEM. NO PATIENT CONSEQUENCES. THERE WAS DELAY IN THE SURGERY OF 10 MINUTES. THE DEVICE IS AVAILABLE TO BE RETURNED FOR EVALUATION.

  Patient problems: Not Applicable

  MAUDE report 10012076 ↗
• MalfunctionApr 29, 2020Device Damaged Prior to Use; Device Damaged Prior to Use

  IT WAS REPORTED BY AFFILIATE VIA EMAIL THE VAPR 3.5 MM SIDE EFFECT 1-PCE ELECTRODE-EA, OPENED PROPERLY, IT CONNECTED NORMALLY TO THE VAPR VUE CONSOLE, WITH A WIRELESS PEDAL, WHEN THE DOCTOR USED IT, DID NOT WORK, IT MARKED AN ERROR, SO IT WAS PRECEDED TO CHANGE THE CONSOLE TO VAP3, THINKING THAT IT WAS THE CONSOLE THAT HAD THE PROBLEM, BUT IN THE NEW CONSOLE IT ALSO MARKED ERROR. THE DR. REQUESTED THAT THE PIECE NOT BE CHARGED, FOR THIS REASON THE HOSPITAL ASKED US FOR THE REPLACEMENT WITHOUT CHARGE, AS WELL AS PUNCTUAL FOLLOW-UP TO THE DIAGNOSIS AND RETURN OF THE DEFECTIVE MATERIAL. THE SURGERY CONTINUED WITHOUT PROBLEMS. THE DEVICE IS AVAILABLE TO BE RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10011746 ↗
• MalfunctionFeb 26, 2020Blocked Connection; Blocked Connection

  IT WAS REPORTED BY THE AFFILIATE VIA EMAIL THAT DURING AN UNKNOWN PROCEDURE WITHOUT SWITCHING ON THE VAPR3.5MM SIDEEFFECT 1-PCE ELECTRODE-EA THE PORTAL GAVE THE ERROR MESSAGE "ELECTRODE NOT RECOGNIZED". THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. NO PATIENT CONSEQUENCE AND NO SURGICAL DELAY WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

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

  MAUDE report 9759442 ↗
• MalfunctionJan 27, 2020Accessory Incompatible; Accessory Incompatible

  IT WAS REPORTED BY SALES CONSULTANT VIA COMPLAINT SUBMISSION TOOL, THAT PRE-OPERATIVELY TO A SHOULDER REPAIR A VAPR SIDE EFFECT ELECTRODE 3.5MM, SIDE EFFECT W/INTEGRATED HANDPIECE, PRESENTED A MALFUNCTION. NO SURGICAL DELAY OR PATIENT CONSEQUENCE REPORTED. ADDITIONAL INFORMATION REPORTED A TWO MINUTE SURGICAL DELAY AND THE CASE WAS COMPLETED WITH ANOTHER READILY AVAILABLE DEVICE. THE AFFILIATE REPORTED SURGICAL INTERVENTION WAS NOT REQUIRED AND THE FAILURE OCCURRED WHEN THE MACHINE DID NOT RECOGNIZE THE ELECTRODE AFTER CONNECTION. IT WAS REPORTED THE DEVICE WILL NOT BE RETURNED FOR EVALUATION BECAUSE IT HAS BEEN DISCARDED.

  Patient problems: Not Applicable

  MAUDE report 9634801 ↗
• MalfunctionDec 26, 2019Excessive Heating; Excessive Heating

  IT WAS REPORTED BY THE AFFILIATE VIA COMPLAINT SUBMISSION TOOL THAT DURING AN UNKNOWN PROCEDURE THE VAPR 3.5MM SIDEEFFECT 1-PCE ELECTRODE-EA TURNED RED COLOR WHEN IT WAS BEEN USED, LIKE IT WAS OVERHEATING. THERE WAS NO PATIENT CONSEQUENCE AND NO SURGICAL DELAY WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9520212 ↗
• MalfunctionDec 10, 2018Disconnection; Disconnection

  IT WAS REPORTED BY THE SALES REP THAT DURING ROTATOR CUFF REPAIR SURGICAL PROCEDURE, IT WAS OBSERVED THAT WHEN THE CUSTOMER'S VAPR 3.5MM SIDE EFFECT ELECTRODE WAS PLUGGED INTO THE GENERATOR, THE DEVICE WAS RECOGNIZED BUT WOULD NOT ABLATE OR COAGULATE. THE PROCEDURE WAS COMPLETED WITH ANOTHER LIKE DEVICE USING THE SAME GENERATOR WITH NO HARM TO THE PATIENT BUT THERE WAS A ONE MINUTE DELAY TO GRAB ANOTHER ELECTRODE. THE ELECTRODE IS NOT A REPROCESSED DEVICE. THE SALES REP WAS NOT PRESENT FOR THE CASE THEREFORE COULD NOT PROVIDE ANY FURTHER INFORMATION. THE DEVICE WILL BE RETURNING FOR EVALUATION. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO 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 Consequences Or Impact To Patient

  MAUDE report 8146333 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K082643. One submission often covers many models, so check the product and lot details in each record.

• Z-0133-2013 · Mar 12, 2012 · Terminated
  DePuy Mitek VAPR Hook Electrode 3.5mm Hook Electrode with Integrated Handpiece Catalog Number: 227305 The DePuy Mitek VAPR Electrodes for use with the VAPR Radiofrequency Syste
• Z-2301-2010 · Jun 7, 2010 · Terminated
  Mitek VAPR Side Effect Electrode (integrated) Product Code: 227301 The VAPR Electrodes (end effect, side effect, wedge, angled, hook, flex, side effect short and wedge short) and V