AEX ™ 40-405-1RRecalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00643169859708), received between Apr 30, 2019 and Jun 4, 2025 — classified as 3 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Output above Specifications” (6 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 4, 2025Fire; Fire

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A GENERATOR. IT WAS REPORTED THAT THE GENERATOR CONSOLE WAS SPARKING I NTERNALLY DURING PREVENTIVE MAINTENANCE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22142392 ↗
• MalfunctionMay 28, 2025Output above Specifications; Output above Specifications

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A GENERATOR. IT WAS REPORTED THAT A PORTION OF THE GENERATOR FAILED AS CUTS 1, 2, 3, AND 5 WERE NOT WITHIN RANGE. ANOTHER GENERATOR WAS USED, AND IT WAS ABLE TO GET CUTS 1-5 TO PASS. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22094267 ↗
• MalfunctionMar 4, 2025Output 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 WHEN SITE PERFORMED PM ON A GENERATOR, THERE WAS A FAILURE ON THE LOW WATTAGE SIDE. ADDITIONALLY, WHEN TESTING CUT 1, THE RESULTS WERE EXTREMELY HIGH, TESTING AT 100 FOR TOLERANCE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21511735 ↗
• MalfunctionDec 30, 2024Electromagnetic Interference; Electromagnetic Interference

  ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS PACEMAKER GENERATOR CHANGE AND THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21035421 ↗
• MalfunctionNov 6, 2024Failure to Power Up; Smoking; Failure to Power Up; Smoking

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A GENERATOR. IT WAS REPORTED THAT THE SYSTEM WAS NOT POWERING UP. REPORTED A STRONG BURNT SMELL AND ONE OF THE BOARDS INSIDE THE UNIT WAS HEAVILY SCORCHED. THERE WAS NO PATIENT PRESENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20618912 ↗
• MalfunctionJun 11, 2024Output above Specifications; Output above Specifications

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A GENERATOR. IT WAS REPORTED THAT WHILE PERFORMING THE PREVENTATIVE MA INTENANCE (PM) ON THE SYSTEM, SEVERAL OF THE VOLTAGES THE SITE WERE MEASURING WERE SIGNIFICANTLY HIGHER THAN THEY SHOULD BE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19508123 ↗
• InjuryMar 12, 2024Electromagnetic Interference; Electromagnetic Interference

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A GENERATOR AND HANDPIECE. IT WAS REPORTED THAT WHEN THE SURGEON WENT TO CUT A POCKET USING A HANDPIECE ON THIS GENERATOR, THE PACER DEPENDENT PATIENT WENT ASYSTOLIC FOR 20 SECOND PRIOR TO BEING HOOKED UP TO A MEDTRONIC PROGRAMMER. OTHERWISE, THERE WERE NO PATIENT ISSUES.

  Patient problems: Cardiac Arrest

  MAUDE report 18888246 ↗
• MalfunctionApr 11, 2023Failure to Shut Off; Unexpected Shutdown; Failure to Shut Off; Unexpected Shutdown

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A GENERATOR AND A HANDPIECE. IT WAS REPORTED THAT ONE OF THE BREAST SURGEONS AT A FACILITY WAS EXPERIENCING A SMALL ISSUE WHEN USING THE HANDPIECE. SPECIFICALLY, AFTER THE COAG BUTTON WAS RELEASED POWER WAS STILL BEING APPLIED TO THE ELECTRODE TIP FOR APPROXIMATELY 3-7 SECONDS. THE SURGEON STATED THAT IN SOME INSTANCES, THE POWER DELIVERY WILL SHUT OFF ON IT'S OWN AFTER A FEW SECONDS OR IN SOME CASES SHE WOULD TOUCH THE ELECTRODE TIP TO A LAP TOWEL OR GAUZE IT THE POWER WOULD STOP FLOWING. THE SURGEON'S CONCERN WAS POTENTIALLY BURNING/CUTTING TISSUE ACCIDENTALLY. SHE ALSO NOTICED IT TENDED TO HAPPEN LONGER INTO THE CASE. THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16716205 ↗
• MalfunctionApr 10, 2023Failure to Shut Off; Unexpected Shutdown; Failure to Shut Off; Unexpected Shutdown

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A GENERATOR AND A HANDPIECE. IT WAS REPORTED THAT ONE OF THE BREAST SURGEONS AT A FACILITY WAS EXPERIENCING A SMALL ISSUE WHEN USING THE HANDPIECE. SPECIFICALLY, AFTER THE COAG BUTTON WAS RELEASED POWER WAS STILL BEING APPLIED TO THE ELECTRODE TIP FOR APPROXIMATELY 3-7 SECONDS. THE SURGEON STATED THAT THIS HAS HAPPENED BEFORE. IN SOME INSTANCES, THE POWER DELIVERY WILL SHUT OFF ON IT'S OWN AFTER A FEW SECONDS OR IN SOME CASES SHE WOULD TOUCH THE ELECTRODE TIP TO A LAP TOWEL OR GAUZE IT THE POWER WOULD STOP FLOWING. THE SURGEON'S CONCERN WAS POTENTIALLY BURNING/CUTTING TISSUE ACCIDENTALLY. SHE ALSO NOTICED IT TENDED TO HAPPEN LONGER INTO THE CASE. THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16708018 ↗
• MalfunctionFeb 3, 2023Melted; Melted

  (B)(4). (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16293081 ↗
• MalfunctionOct 11, 2021Smoking; Smoking

  2021-OCT-06 SAP ECC SERVICE AND REPAIR 000302587902 (HCP): INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A GENERATOR. IT WAS REPORTED THAT UNIT EMITTED A BURNING SMELL WHEN POWERED ON. NO PATIENT WAS PRESENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12605943 ↗
• MalfunctionJun 28, 2021Failure to Power Up; Arcing of Electrodes; Failure to Power Up; Arcing of Electrodes

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE REP STATED THAT THE GENERATOR WAS SHOWING OTHER SIGNS OF ISSUES, SO IT WAS NO LONGER IN USE. THERE WAS NO ADVERSE CONSEQUENCES TO THE DOCTOR AS A RESULT OF THE ISSUE

  Patient problems: Burn(s); No Clinical Signs, Symptoms or Conditions; Shock

  MAUDE report 12075983 ↗
• MalfunctionApr 9, 2021Output above Specifications; Output above Specifications

  INFORMATION WAS RECEIVED FROM A MANUFACTURING REPRESENTATIVE (REP) REGARDING A GENERATOR. IT WAS REPORTED THAT THE UNIT FAILED ELECTRICAL LEAKAGE TESTING AND WAS ABOVE THE REQUIRED PARAMETERS IN BIOMEDICAL TESTING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11646356 ↗
• MalfunctionMar 30, 2021Fire; Fire

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) REGARDING A GENERATOR AND HANDPIECE. IT WAS REPORTED THAT THE SYSTEM WAS INVOLVED WITH A HANDPIECE BURN TO THE PA ASSISTANT DURING A CASE. THE BIOMED STATED THAT THE SITE NO LONGER HAD THE ACTUAL HANDPIECE. THE SITE WAS RECOMMENDED TO EXCHANGE THE GENERATOR AS A PRECAUTION. IT WAS BELIEVED THAT IT WAS USER ERROR, BUT SINCE THE HANDPIECE WAS NO LONGER AVAILABLE THAT WAS UNABLE TO BE DETERMINED.

  Patient problems: Burn(s)

  MAUDE report 11592529 ↗
• MalfunctionMar 15, 2021Melted; Overheating of Device; Melted; Overheating of Device

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MANUFACTURE REPRESENTATIVE (REP) REGARDING A GENERATOR AND A HANDPIECE. IT WAS REPORTED THAT THE DOCTOR INDICATED THAT THE HANDPIECE (PLASTIC HANDLE) GOT HOT IN HIS HANDS AND THE PLASTIC STARTED TO MELT. THERE WAS NO IMPACT TO PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11486320 ↗
• MalfunctionFeb 2, 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 THE SITE HAD AN ISSUE WITH THE NON-STICK COATING ON THE PLASMA BLADE FLAKING. ADDITIONAL INFORMATION RECEIVED STATED THAT THE GENERATOR WAS STILL IN USE AND THEY PULLED ANOTHER DEVICE TO RESOLVE THE ISSUE. THERE WAS NO IMPACT TO PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11267419 ↗
• MalfunctionJan 19, 2021Failure to Shut Off; Failure to Shut Off

  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 CASE, THE LIGHTED PLASMA BLADE HANDPIECE MALFUNCTIONED. IT WAS STATED THAT THE HANDPIECE HAD CONTINUOUS POWER WHEN NEITHER THE CUT NOR COAG WAS ACTIVATED ON THE HANDPIECE SWITCH. IT WAS ALSO STATED THAT THIS HAPPENED WHILE HE WAS OPENING UP THE POCKET. THE HANDPIECE WAS DISCARDED BY THE SITE. THERE WAS NO REPORTED IMPACT TO PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11193959 ↗
• MalfunctionNov 24, 2020Arcing of Electrodes; Arcing of Electrodes

  INFORMATION WAS RECEIVED FROM A MANUFACTURING REPRESENTATIVE (REP) REGARDING A GENERATOR. IT WAS REPORTED THAT THE SITE WAS HAVING ISSUES WHERE THE SYSTEM WAS ARCHING WITH SOME OF THE HANDPIECE WHEN TESTING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10891156 ↗
• MalfunctionNov 24, 2020Output above Specifications; Output above Specifications

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) REGARDING A GENERATOR. IT WAS REPORTED THAT THE GENERATOR WAS FAILING OUTPUT TESTING. THEY WERE WITHIN SPECULATION ON THE CUT 8, CUT 10, AND COAG 5, BIT NOT ON COAG 8. THEY WERE GETTING AN OUTPUT OF 90 WHEN IT SHOULD HAVE BEEN 38 +/-20%. THERE WAS NO PATIENT PRESENT AS THE ISSUE WAS DISCOVERED DURING PREVENTATIVE MAINTENANCE (PM).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10890057 ↗
• InjuryAug 13, 2020Arcing of Electrodes; Arcing of Electrodes

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) REGARDING A GENERATOR AND HANDPIECE. IT WAS REPORTED THAT WHILE USING THE GENERATOR, A SCRUB TECH STATED THEY RECEIVED A SHOCK WHILE LEANING ON A WET TOWEL NEAR THE PATIENT WHILE THE HANDPIECE AND GENERATOR WERE BEING USED. THERE WAS NO HARM TO PATIENT. SCRUB TECH ONLY HAD A RED MARK ON THEIR SKIN. ADDITIONAL INFORMATION WAS RECEIVED FROM THE HCP AND IT WAS FURTHER STATED THAT AFTER SOME CLARIFICATION AND INFORMATION CONCERNING THIS CASE WITH THE OPERATING SURGEON¿S HELP, THE EQUIPMENT WAS WORKING NORMALLY. THE OPERATING SURGEON CONTINUED WITH THE CASE USING THE SAME EQUIPMENT AND HAND PIECE WITHOUT ANY PROBLEMS. THE OPERATING ROOM HAD ONLY ONE MODEL HANDPIECE FOR THE USE OF THIS EQUIPMENT. THE HANDPIECE WAS DISCARDED. THERE WAS NO SPARK OR ARC SEEN. THE REP WAS UNCERTAIN THAT THERE WAS A SHOCK. THE SAME EQUIPMENT AND HAND PIECE WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: Burn(s); Electric Shock

  MAUDE report 10403740 ↗
• MalfunctionAug 13, 2020Failure to Shut Off; Failure to Shut Off

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MANUFACTURING REPRESENTATIVE (REP) REGARDING A GENERATOR AND A HANDPIECE. IT WAS REPORTED THAT THE SITE WAS UNABLE TO STOP ENERGY ON THE BIPOLAR HANDPIECE AND NEEDED TO USE A DIFFERENT ONE TO CONTINUE THE CASE. THERE WAS NO IMPACT ON PATIENT OUTCOME AND THE HCP WAS TRANSFERRED TO SERVICE AND REPAIR.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10400504 ↗
• MalfunctionJun 8, 2020Arcing of Electrodes; Arcing of Electrodes

  INFORMATION WAS RECEIVED FROM A MANUFACTURE REPRESENTATIVE (REP) REGARDING A GENERATOR AND A HANDPIECE. IT WAS REPORTED THAT THE SYSTEM WAS ARCING WHEN THEY PLUG IN HAND PIECE AND THE UNIT NEEDED TO BE SENT IN FOR REPAIR. NO PATIENT INVOLVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10128598 ↗
• MalfunctionMay 2, 2019Output above Specifications; Output above Specifications

  NO SURGERY INVOLVED OUTSIDE SURGICAL ENVIRONMENT NO SURGICAL DELAY DURING CHECK IN TESTING, BIOMED DISCOVERED THAT THE EARTH/RESISTANCE TESTED HIGH WITH THE AEX POWER CORD. WITH BIOMED'S HOSPITAL GRADE POWER CORD, THE GENERATOR TESTED CORRECTLY. AS IT IS A SALES REP'S GENERATOR, THE GENERATOR WILL BE REPLACED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8573611 ↗
• InjuryApr 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MANUFACTURER REPRESENTATIVE (REP) THAT DURING THE CASE AN TOTAL HIP ARTHROPLASTY, THE SURGEON REPORTED THAT SHE CUT HER FINGER ON THE HANDPIECE WHILE OPERATING. STAFF STATED THE SETTINGS WERE CUT 6 AND COAG 7. STAFF SUCCESSFULLY COMPLETED THE CASE WITH A BOVIE. NO FURTHER DETAILS ARE AVAILABLE AT THIS TIME. PATIENT INFORMATION PROVIDED BUT SURGEON REFUSED TO PROVIDE HER INFORMATION. ADDITIONAL INFORMATION FROM THE REP ON APRIL 10TH REPORTED THE PATIENT WAS NOT INJURED. IT WAS NOTED THE INFORMATION WAS CONFIRMED WITH THE HCP.

  Patient problems: Tissue Damage

  MAUDE report 8564747 ↗