AEX™ 40-405-1RRecalls & reported problems

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 00763000280321), received between Sep 10, 2020 and Apr 14, 2026 — classified as 3 injuries, 34 malfunctions.

The most frequently reported specific device problem is “Output above Specifications” (9 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 37 reports, in the reporter's own words as published by the FDA.

• InjuryApr 14, 2026Adverse Event Without Identified Device or Use Problem; Activation Problem

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A GENERATOR AND A HANDPIECE. IT WAS REPORTED THAT DURING A CARDIAC HEART TRANSPLANT PROCEDURE, A THERMAL INJURY/BURN WAS IDENTIFIED ON THE PATIENT¿S LOWER LEFT ABDOMEN DURING THE POST-OPERATIVE SKIN ASSESSMENT. THE TEAM ESCALATED APPROPRIATELY AND THE PATIENT WAS HELD FOR A PLASTIC SURGERY CONSULTATION PRIOR TO TRANSFER TO THE INTENSIVE CARE UNIT. THE BIPOLAR HANDPIECE WAS DISPOSED OF BY THE SITE AND WAS NOT RETURNED. THE ISSUE OCCURRED INTRA-OPERATIVELY AND PATIENT WAS AFFECTED.

  Patient problems: Burn(s)

  MAUDE report 24869324 ↗
• MalfunctionApr 6, 2026Fire

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A GENERATOR AND HANDPIECE. IT WAS REPORTED THAT, DURING SURGERY, A HANDPIECE PRODUCED SPARKS, AND SPARKS WERE ALSO OBSERVED COMING OUT OF THE GENERATOR. THE ISSUE OCCURRED INTRA-OPERATIVELY, PATIENT WAS INVOLVED BUT NO REPORTED IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24796238 ↗
• MalfunctionNov 20, 2025Failure to Shut Off; Failure to Shut Off

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A GENERATOR. IT WAS REPORTED THAT DURING PROCEDURE, THERE WAS NO OR INSUFFICIENT BIPOLAR ENERGY IDENTIFIED WITH THE GENERATOR. THERE WAS NO REPORTED IMPACT ON PATIENT. 2025-OCT-29 E1 (REP): ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE SURGEON WOULD ACTIVATE THE DEVICE (BY PRESSING THE CUT OR COAG BUTTON) BUT IT WOULD NOT DEACTIVATE WHEN HER FINGER CAME OFF THE BUTTON. THE DEVICE WAS STILL ACTIVATED EVEN THOUGH SHE WAS NOT PRESSING THE BUTTON AT ALL. IT WOULD REMAIN UNTIL SHE GROUNDED IT ON THE PATIENT OR OTHER OBJECT. THE PROBLEM OCCURRED INTRA-OPERATIVELY DURING BREAST SURGERY (MASTECTOMY) AND THERE WAS NO IMPACT TO PATIENT. ISSUE CAUSED MINOR DELAYS OF LESS THAN AN HOUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23603901 ↗
• MalfunctionNov 13, 2025No Device Output; Failure to Shut Off; No Device Output; Failure to Shut Off

  IT WAS REPORTED THAT DURING A PROCEDURE THE GENERATOR DISPLAYED ERROR F9 DURING USE. SITE REPORTED THAT THE HANDPIECE CONTINUED TO FIRE WHEN THE BUTTON WAS NOT BEING PRESSED. THEY USED ANOTHER SYSTEM TO PROCEED AND WAS UNABLE TO REPLICATE ISSUE AFTER THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23543832 ↗
• MalfunctionOct 26, 2025Fire; Device Damaged Prior to Use; Fire; Device Damaged Prior to Use

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A GENERATOR. IT WAS REPORTED THAT THE GENERATOR WAS DROPPED WHILE BEING MOVED, RESULTING IN DAMAGE TO THE GENERATOR CASE AND A REPORT THAT IT SUPPOSEDLY SPARKED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23387858 ↗
• MalfunctionMay 26, 2025No Device Output; Arcing of Electrodes; No Device Output; Arcing of Electrodes

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A GENERATOR. IT WAS REPORTED THAT A REPLACEMENT UNIT WAS SHIPPED AND FAILED ITS ELECTRICAL SAFETY DUE TO A SEVERE GROUND FAULT WHEN BEING POWERED ON, CAUSING CURRENT TO BE PUSHED OUT OF THE CHASSIS GROUND. THE DEVICE WAS NEVER PLACED INTO SERVICE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22084662 ↗
• MalfunctionApr 25, 2025Failure to Shut Off; Failure to Shut Off

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A GENERATOR. IT WAS REPORTED THAT DURING PROCEDURE, THE GENERATOR CONTINUED TO PROVIDE POWER TO THE HANDPIECE DESPITE ATTEMPTS TO DEPRESS THE COAGULATION BUTTON, INDICATING AN INABILITY TO TURN OFF COAGULATION. THE ISSUE PERSISTED EVEN AFTER ANOTHER HANDPIECE WAS OPENED. THE PROBLEM WAS RESOLVED BY BRINGING IN ANOTHER GENERATOR. THERE WAS A SURGICAL DELAY OF LESS THAN 1 HOUR AND NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21906899 ↗
• MalfunctionMar 20, 2025Fire; Device Damaged Prior to Use; Intermittent Energy Output; Fire; Device Damaged Prior to Use; Intermittent Energy Output

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A GENERATOR. IT WAS REPORTED THAT A GENERATOR WAS EXPERIENCING ISSUES, SPECIFICALLY SHORTING OUT WHENEVER A HANDPIECE WAS PLUGGED IN. ADDITIONALLY, IT WAS OBSERVED THAT THE UNIT APPEARED TO HAVE BEEN DR OPPED, RESULTING IN PHYSICAL DAMAGE AND CAUSING IT TO WORK INTERMITTENTLY. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21651411 ↗
• MalfunctionFeb 25, 2025Energy Output Problem; Output above Specifications; Output below Specifications; Energy Output Problem; Output above Specifications; Output below Specifications

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A GENERATOR. IT WAS REPORTED THAT DURING PREVENTIVE MAINTENANCE, A GEN ERATOR HAD FAILED THE CUT TEST AND HAD SHOWN THE VALUES THAT WERE NOT EXPECTED. THE CUT OUTPUT ISSUE WAS IDENTIFIED, WHERE THE DEVICE, WHEN SET FOR 2 WATTS, HAD ONLY OUTPUTTED LOW VALUE 0.8 WATTS, AND WHEN SET FOR 8 WATTS, IT HAD OUTPUTTED THE HIGHER VALUE OVER 49 WATTS. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21455918 ↗
• MalfunctionNov 26, 2024Output above Specifications; Output above Specifications

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A GENERATOR. IT WAS REPORTED THAT WHILE PERFORMING A PM WITH THE HANDPIECE, CUT 4-5 HAD TOLERANCES ABOVE SPECIFICATIONS. CUT 4 WAS APPROXIMATELY 7, CUT 5 WAS 13. AND CUT 3 WAS 3.9. ALL OTHER CUTS WERE WITHIN THE TOLERANCES. NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20783649 ↗
• MalfunctionJul 5, 2024Output above Specifications; Failure to Shut Off; Output above Specifications; Failure to Shut Off

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A GENERATOR. IT WAS REPORTED THA T DURING TWO CASES A GENERATOR WAS USED AND EXCESS POWER WAS DELIVERED TO TWO SEPARATE HANDPIECES AND MAY HAVE RESULTED IN HARM TO THE PATIENTS. THE COAG FUNCTION WAS GETTING "STUCK"; IT STAYED ACTIVE AND DELIVERED POWER EVEN AFTER IT WAS LET GO. THERE WAS NO DELAY OR PATIENT IMPACT REPORTED. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT ONE PATIENT WAS BURNED CLOSE TO THE INCISION AND THE ISSUE OCCURRED DURING A BREAST LUMPECTOMY WITH SENTINEL NODES PROCEDURE AND A EXCISIONAL BIOPSY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19681194 ↗
• MalfunctionJun 7, 2024Overheating of Device; Failure to Shut Off; Overheating of Device; Failure to Shut Off

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A GENERATOR. IT WAS REPORTED THAT THE GENERATOR WOULD GET HOT AND WOULDN'T TURN OFF WHEN POWER BUTTON WAS USED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19488095 ↗
• MalfunctionFeb 13, 2024Arcing of Electrodes; Arcing of Electrodes

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A GENERATOR AND HANDPIECE BEING USED FOR A BREAST PROCEDURE. IT WAS REPORTED THAT DURING A CASE, THE DOCTOR USED A FORCEPS TO CLAMP OFF A VESSEL AND TOUCHED THE HANDPIECE TO FORCEPS TO CAUTERIZE THE VESSEL. THE SITE MENTIONED THERE WAS A NICE SIZE SPARK/ARC OF ENERGY. THE SITE WOULD LIKE THE HANDPIECE SENT IN FOR EVALUATION. THERE WAS A DELAY OF LESS THAN 1 HOUR AND NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18697598 ↗
• MalfunctionNov 20, 2023Output above Specifications; Incomplete or Inadequate Connection; Output above Specifications; Incomplete or Inadequate Connection

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A GENERATOR. IT WAS REPORTED THAT DURING PREVENTATIVE MAINTENANCE (PM) IT GAVE HIGH OUTPUT AND WOULDN'T TELL WHICH HANDPIECE WAS ATTACHED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18170801 ↗
• MalfunctionSep 11, 2023Overheating of Device; Overheating of Device

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A GENERATOR. IT WAS REPORTED THAT A PATIENT WAS BURNT EXTERNALLY WHILE A HANDPIECE WAS IN USE. IT WAS SUSPECTED THAT THE HANDPIECE WAS NOT PROPERLY STORED WHILE NOT BEING ACTIVELY USED, AND THE FOOTSWITCH INADVERTENTLY WAS ACTIVATED. THE BURNS WERE NOT NOTICED UNTIL THE PROCEDURE WAS COMPLETED, THERE WERE TWO SMALL MARKS THAT ARE BEING TREATED. THE EVENT OCCURRED DURING A PEDIATRIC SCOLIOSIS PROCEDURE. THERE WAS NO DELAY.

  Patient problems: Burn(s)

  MAUDE report 17720460 ↗
• MalfunctionJul 14, 2023Smoking; Smoking

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A GENERATOR. IT WAS REPORTED THAT THERE WAS A BURNING SMELL WHEN IN USE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17324802 ↗
• MalfunctionApr 17, 2023Electromagnetic Interference; Electromagnetic Interference

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A GENERATOR. IT WAS REPORTED THAT THEY HAD AN INTERFERENCE ISSUE BETWEEN THEIR PATIENT MONITORING SYSTEM AND THE GENERATOR UNIT DURING A CASE. THERE WAS ¿NOISE¿ ON THE EKG READINGS THAT WERE FALSELY INTERPRETED AS A-FLUTTER. THEY DID NOT KNOW IF THE ISSUE CAME FROM THE MONITORING SYSTEM OR THE GENERATOR. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16751439 ↗
• MalfunctionApr 17, 2023Electromagnetic Interference; Electromagnetic Interference

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A GENERATOR. IT WAS REPORTED THAT THEY HAD AN INTERFERENCE ISSUE BETWEEN THEIR PATIENT MONITORING SYSTEM AND THE GENERATOR UNIT DURING A CASE. THERE WAS ¿NOISE¿ ON THE EKG READINGS THAT WERE FALSELY INTERPRETED AS A-FLUTTER. THEY DID NOT KNOW IF THE ISSUE CAME FROM THE MONITORING SYSTEM OR THE GENERATOR. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16751410 ↗
• MalfunctionMar 31, 2023Failure to Shut Off; Failure to Shut Off

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A GENERATOR. IT WAS REPORTED THAT THE GENERATOR PUMP WAS RUNNING NON-STOP. NO FURTHER INFORMATION WAS PROVIDED. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16656202 ↗
• MalfunctionFeb 1, 2023Device Damaged Prior to Use; Device Damaged Prior to Use

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A GENERATOR. IT WAS REPORTED THAT THE SYSTEM HAD BEEN DROPPED AND WAS CRACKED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16278821 ↗
• InjuryJan 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A GENERATOR AND A HANDPIECE. IT WAS REPORTED THAT MONTHS AFTER GETTING A KNEE SURGERY FROM THE SITE, THREE SEPARATE PATIENTS RETURNED WITH AN INFECTION. ACCORDING TO THE SITE, THE THREE SURGERIES USED THE SAME GENERATORS (CLEANED IN-BETWEEN) AND WITH SEPARATE HANDPIECES (ALL OF THE SAME KIND). THE PATIENTS REPORTED INFECTIONS TO THE SITE AROUND THE FIRST WEEK OF (B)(6) 2023.

  Patient problems: Unspecified Infection

  MAUDE report 16162084 ↗
• InjuryJan 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A GENERATOR AND A HANDPIECE. IT WAS REPORTED THAT MONTHS AFTER GETTING A KNEE SURGERY FROM THE SITE, THREE SEPARATE PATIENTS RETURNED WITH AN INFECTION. ACCORDING TO THE SITE, THE THREE SURGERIES USED THE SAME GENERATORS (CLEANED IN-BETWEEN) AND WITH SEPARATE HANDPIECES (ALL OF THE SAME KIND). THE PATIENTS REPORTED INFECTIONS TO THE SITE AROUND THE FIRST WEEK OF JANUARY 2023.

  Patient problems: Unspecified Infection

  MAUDE report 16157476 ↗
• MalfunctionNov 23, 2022Output above Specifications; No Device Output; Output below Specifications; Activation Problem; Output above Specifications; No Device Output; Output below Specifications; Activation Problem

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A GENERATOR. IT WAS REPORTED THAT THEY JUST RECEIVED THE NEW GENERATOR AND IT WAS ALSO FAILING THEIR PREVENTATIVE MAINTENANCE (PM) MEASUREMENTS. THIS WAS THE THIRD UNIT THEY HAVE RECEIVED THAT WAS FAILING. THE READINGS THEY WERE RECEIVING WAS CUT 7 - 29.0 W, CUT 8 - 38 W, COAG 5 - 50.4 W, CUT 10 - 50.8 W. THEY ADVISED THAT THEIR ANALYZER HAD RECENTLY BEEN CALIBRATED AND TESTED. THERE WAS CUT AND COAG ERROR. THEY ALSO REPORTED OF A TOTAL OF 3 UNITS FAILING THE PM MEASUREMENTS. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15852438 ↗
• MalfunctionNov 23, 2022Output above Specifications; No Device Output; Output below Specifications; Activation Problem; Output above Specifications; No Device Output; Output below Specifications; Activation Problem

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A GENERATOR. IT WAS REPORTED THAT THEY JUST RECEIVED THE NEW GENERATOR AND IT WAS ALSO FAILING THEIR PREVENTATIVE MAINTENANCE (PM) MEASUREMENTS. THIS WAS THE THIRD UNIT THEY HAVE RECEIVED THAT WAS FAILING. THE READINGS THEY WERE RECEIVING WAS CUT 7 - 29.0 W, CUT 8 - 38 W, COAG 5 - 50.4 W, CUT 10 - 50.8 W. THEY ADVISED THAT THEIR ANALYZER HAD RECENTLY BEEN CALIBRATED AND TESTED. THERE WAS CUT AND COAG ERROR. THEY ALSO REPORTED OF A TOTAL OF 3 UNITS FAILING THE PM MEASUREMENTS. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15852408 ↗
• MalfunctionNov 23, 2022Output above Specifications; No Device Output; Output below Specifications; Activation Problem; Output above Specifications; No Device Output; Output below Specifications; Activation Problem

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A GENERATOR. IT WAS REPORTED THAT THEY JUST RECEIVED THE NEW GENERATOR AND IT WAS ALSO FAILING THEIR PREVENTATIVE MAINTENANCE (PM) MEASUREMENTS. THIS WAS THE THIRD UNIT THEY HAVE RECEIVED THAT WAS FAILING. THE READINGS THEY WERE RECEIVING WAS CUT 7 - 29.0 W, CUT 8 - 38 W, COAG 5 - 50.4 W, CUT 10 - 50.8 W. THEY ADVISED THAT THEIR ANALYZER HAD RECENTLY BEEN CALIBRATED AND TESTED. THERE WAS CUT AND COAG ERROR. THEY ALSO REPORTED OF A TOTAL OF 3 UNITS FAILING THE PM MEASUREMENTS. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15852384 ↗