AEX ™ 40-405-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 00643169859678), received between Feb 10, 2020 and Aug 18, 2026 — classified as 3 injuries, 32 malfunctions.

The most frequently reported specific device problem is “Output above Specifications” (11 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 25 most recent of 35 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 18, 2026Output above Specifications

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50299234 ↗
• MalfunctionAug 4, 2026Use of Device Problem; Arcing of Electrodes

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50125607 ↗
• InjuryJun 23, 2026Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A GENERATOR. IT WAS REPORTED THAT THE PHYSICIAN WAS USING CAUTERY DURING AN ICD EXPLANT AND FELT A SUDDEN BURN ON THE RIGHT ARM. THE PHYSICIAN¿S GOWN WAS BURNED. IT WAS REPORTED THAT THE GROUNDING PAD OR AN ACCESSORY MAY HAVE CAUSED THE ISSUE. THE ISSUE OCCURRED INTRAOPERATIVELY. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE ISSUE OCCURRED DURING ICD IMPLANT AND THE INJURY TO THE PHYSICIAN WAS MINOR. THERE WAS NO IMPACT TO THE PATIENT OUTCOME. THERE WAS A DELAY OF LESS THAN 30 MINS TO THE PROCEDURE.

  Patient problems: Burn(s)

  MAUDE report 25598473 ↗
• MalfunctionFeb 4, 2026Output above Specifications

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A GENERATOR. IT WAS REPORTED THAT DURING PREVENTIVE MAINTENANCE (PM) ON THE GENERATOR, BIPOLAR OUTPUT FAILURE OCCURRED, WITH THE GENERATOR UNABLE TO PRODUCE WATTAGE WITHIN TOLERANCE AND OUTPUT WATTAGE MEASURED AT MORE THAN DOUBLE THE MAXIMUM TOLERANCE DURING TESTING. IMPEDANCE MEASUREMENT WAS 100 OHMS, WATTAGE MEASUREMENT WAS 110 WATTS, AND OUTPUT MEASUREMENT WAS 280 WATTS, WITH OTHER SIMILAR TESTS CONFIRMING THE OUTPUT ISSUE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24257238 ↗
• MalfunctionFeb 10, 2025Melted; Melted

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A GENERATOR. IT WAS REPORTED THAT DURING A HIP REVISION SURGERY, THE PLASTIC ON THE HANDPIECE WAS MELTED. THE HANDPIECE WAS USED AGAINST METAL, SUCH AS A HEMOSTAT, WHICH WAS LIKELY THE CAUSE OF THE MELTING. ONCE THE ISSUE OCCURRED, THE SURGICAL TEAM SWITCHED TO USING A OTHER HANDPIECE. THE INCIDENT HAPPENED TOWARDS THE END OF THE PROCEDURE, WHICH LASTED ALMOST FOUR HOURS. THERE WAS A SURGICAL DELAY OF LESS THAN ONE HOUR AND WAS NO REPORTED IMPACT ON PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21343242 ↗
• MalfunctionJan 29, 2025Fire; Fire

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A GENERATOR. IT WAS REPORTED THAT THERE WAS A BURNING SMELL FROM GENER ATOR. NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21262904 ↗
• MalfunctionOct 18, 2024Fire; Fire

  ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE PROCEDURE PERFORMED DURING THE EVENT WAS SPINE CASE AND THERE WAS A MINIMAL DELAY IN SURGICAL PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20479498 ↗
• MalfunctionOct 16, 2024Electromagnetic Interference; Electromagnetic Interference

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A GENERATOR. IT WAS REPORTED THAT THE SITE HAD A GENERATOR THAT WHEN ACTIVATED CAUSED THE EKG MACHINE NEARBY TO STOP WORKING. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20462487 ↗
• MalfunctionFeb 16, 2024Output above Specifications; Output above Specifications

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A GENERATOR. IT WAS REPORTED THAT THE SYSTEM FAILED THE TOLERANCE WITH 220W ON A 3 PIN DEVICE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18720895 ↗
• MalfunctionNov 9, 2023Output above Specifications; Output above Specifications

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A GENERATOR. IT WAS REPORTED THAT WHILE DOING THE ANNUAL PREVENTATIVE MAINTENANCE (PM), THE SITE FOUND THAT CUT 8 AND COAG 5 WERE MEASURING OUTSIDE OF TOLERANCES. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18102789 ↗
• InjuryJul 14, 2023Break; Device Damaged Prior to Use; Break; Device Damaged Prior to Use

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A GENERATOR. IT WAS REPORTED THAT THE SITE BELIEVES THE FRONT PUMP ON THEIR SYSTEM WAS CAUSING THE TUBE ON THEIR HANDPIECE TO BREAK. THEY STATED THAT THIS HAPPENED TWICE IN TWO SEPARATE CASES. THE OR STAFF NOTICED THAT THE TUBING WAS DAMAGED AT THE END OF THE CASE, AND WAS NOT REPLACED DURING THE CASE. THE SITE SAID THAT THE PATIENT WAS IMMUNOCOMPROMISED AND WAS ALLEGING THAT THE PATIENT WAS INFECTED WITH E. COLI DUE TO THE TUBING BREAKING DURING THE CASE. THERE WAS NO DELAY TO THE PROCEDURE.

  Patient problems: Unspecified Infection

  MAUDE report 17329481 ↗
• MalfunctionJul 13, 2023Device Damaged Prior to Use; Device Damaged Prior to Use

  INFORMATION WAS RECEIVED FROM AN UNKNOWN SOURCE REGARDING A GENERATOR. IT WAS REPORTED THAT THE SITE BELIEVES THE FRONT PUMP ON THEIR GENERATOR SYSTEM WAS CAUSING THE TUBE ON THEIR HANDPIECE TO BREAK. THE SITE STATED THAT THIS HAPPENED TWICE IN TWO SEPARATE CASES. THE OR STAFF NOTICED THAT THE TUBING WAS DAMAGED DURING THE CASE, SO IT WAS REPLACED. THERE WAS A DELAY OF LESS THAN 1 HOUR AND THE PATIENT WAS REPORTEDLY AFFECTED. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS CONFIRMED THAT THERE WAS NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17317208 ↗
• MalfunctionMay 16, 2023Output above Specifications; Output below Specifications; Output above Specifications; Output below Specifications

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A GENERATOR. IT WAS REPORTED THAT THE CUT AND/OR COAG OUTPUT WERE OUT OF SPEC. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16940250 ↗
• MalfunctionMay 16, 2023Output above Specifications; Output below Specifications; Output above Specifications; Output below Specifications

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A GENERATOR. IT WAS REPORTED THAT THE CUT AND/OR COAG OUTPUT WERE OUT OF SPEC. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16940165 ↗
• MalfunctionFeb 17, 2023Fire; Fire

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A GENERATOR AND HANDPIECES. IT WAS REPORTED THAT THE SITE REPORTED TWO INSTANCES OF SPARKING HANDPIECES DURING THE SAME CASE. THE ACCOUNT ADMITTED TO TOUCHING ANOTHER METAL HANDPIECE FOR THE FIRST INSTANCE OF SPARKS. TO RECTIFY THE SITUATION, THE STAFF REPLACED THE HANDPIECE AND THE GENERATOR. HOWEVER, IT WAS REPORTED THAT THE SECOND HANDPIECE AND SECOND GENERATOR ALSO CAUSED A SPARK WITHOUT TOUCHING ANOTHER METAL OBJECT. THE ORDER IN WHICH THEY WERE USED WAS UNKNOWN. THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16397421 ↗
• MalfunctionFeb 17, 2023Fire; Fire

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A GENERATOR AND HANDPIECES. IT WAS REPORTED THAT THE SITE REPORTED TWO INSTANCES OF SPARKING HANDPIECES DURING THE SAME CASE. THE ACCOUNT ADMITTED TO TOUCHING ANOTHER METAL HANDPIECE FOR THE FIRST INSTANCE OF SPARKS. TO RECTIFY THE SITUATION, THE STAFF REPLACED THE HANDPIECE AND THE GENERATOR. HOWEVER, IT WAS REPORTED THAT THE SECOND HANDPIECE AND SECOND GENERATOR ALSO CAUSED A SPARK WITHOUT TOUCHING ANOTHER METAL OBJECT. THE ORDER IN WHICH THEY WERE USED WAS UNKNOWN. THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16397413 ↗
• MalfunctionAug 1, 2022Activation Problem; Activation Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A GENERATOR. IT WAS REPORTED THAT A SURGEON COMPLAINT OF THE GENERATOR HAVING TOO MUCH OUTPUT. AFTER SWAPPING THE GENERATORS DURING THE CASE, THE PLASMABLADE HANDPIECE SEEMED TO FUNCTION AS INTENDED. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15139679 ↗
• MalfunctionJan 10, 2022Output above Specifications; Output below Specifications; Output above Specifications; Output below Specifications

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A GENERATOR. IT WAS REPORTED THAT THE CUT 8 WAS OUT OF SPEC DURING PM TESTING. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13205137 ↗
• MalfunctionNov 2, 2021Patient-Device Incompatibility; Patient-Device Incompatibility

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A GENERATOR. IT WAS REPORTED THAT DURING A PREVENTATIVE MAINTENANCE (PM), THE ELECTRODES WERE BEING ACTIVATED WHILE THE REM PAD WAS NOT CONNECTED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12738137 ↗
• MalfunctionSep 7, 2021Fire; Noise, Audible; Fire; Noise, Audible

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A GENERATOR. IT WAS REPORTED THAT THERE WAS A LOUD POPPING NOISE AND SMOKE COMING OUT OF THE GENERATOR. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12433796 ↗
• MalfunctionJul 21, 2021Output above Specifications; Output above Specifications

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) REGARDING A GENERATOR. IT WAS REPORTED THAT THE POWER OUTPUT FOR CUT 1-5 WERE FALLING OUTSIDE OF TOLERANCE. (SPECIFICALLY CUT 5 WAS AT 14.9 WATTS) FOUND DURING BIOMED TESTING. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12208029 ↗
• MalfunctionApr 9, 2021Failure to Shut Off; Failure to Shut Off

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE REP AND IT WAS STATED THAT THE HANDPIECE WAS DISCARDED AND THE GENERATOR WAS WITH THE BIOMED. THE DELAY WAS LESS THAN AN HOUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11646413 ↗
• MalfunctionMar 22, 2021Peeled/Delaminated; Peeled/Delaminated

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MANUFACTURE REPRESENTATIVE (REP) REGARDING A GENERATOR AND A HANDPIECE. IT WAS REPORTED THAT DURING A PROCEDURE, THE END OF A PLASMABLADE HANDPIECE BEGAN TO FLAKE OFF. THE USE OF THE HANDPIECE WAS DISCONTINUED AND THE SURGEON CONTINUED WITH A BOVI. THERE WAS NO PATIENT IMPACT. THE CORD HAS BEEN REMOVED FROM THE HANDPIECE AND BOX DISCARDED. (B)(6) 2021. NO NEW INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11542703 ↗
• MalfunctionFeb 26, 2021Activation Problem; Activation Problem

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MANUFACTURE REPRESENTATIVE (REP) REGARDING A GENERATOR. IT WAS REPORTED THAT THE TEMPERATURE OF THE DEVICE WAS HOTTER THAN THE SURGEON EXPECTED. THE UNIT WAS PRODUCING A HIGHER OUTPUT THAN NORMAL. IT WAS SWAPPED FOR ANOTHER GENERATOR THAT APPEARED TO NOT HAVE THAT ISSUE. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE HANDPIECE WAS USED ON A DIFFERENT GENERATOR AND WORKED FINE. THEY DISPOSED OF IT AFTER CASE. THE CAUSE OF THE ISSUE WAS NOT KNOWN AT THE TIME. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11386585 ↗
• MalfunctionFeb 3, 2021Output above Specifications; Output above Specifications

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) REGARDING A GENERATOR. IT WAS REPORTED THAT DURING TESTING HE FOUND THAT THE COAG OUTPUTS WERE HIGHER THAN TOLERANCE VALUES. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11272881 ↗