AcuPulse 40WGRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 07290109140315), received between Oct 6, 2019 and Dec 16, 2021 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Failure to Deliver Energy” (4 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 16, 2021Optical Problem; Optical Problem

  LUMENIS WAS INFORMED BY A FOREIGN DISTRIBUTOR THAT A FOREIGN USER FACILITY REPORTED THAT DURING A PROCEDURE IN WHICH A LUMENIS ACUPULSE 40 W CO2 LASER SYSTEM WAS BEING UTILIZED, "THE SETTING WAS 0.5 WATTS, CONTINUOUS PULSE, 0.2 SEC ON AND 0.5 SEC OFF. IN THE MIDDLE OF THE CASE, THEY HAD TO STOP FOR A LITTLE WHILE FOR THE PATIENT TO RECOVER. THEY LASERED AGAIN. THEY STARTED FOR 2 PULSES AND NOTICED THE PATIENT DEVELOPED A LARGE BURN (ABOUT 1-1.5 CM) ON THE RIGHT SIDE OF THE SUPRAGLOTTIS. THEY HAD TO ABANDON THE CASE AND BELIEVE THE LASER HAD MISFIRED".

  Patient problems: Burn(s)

  MAUDE report 13018357 ↗
• MalfunctionNov 8, 2021No Display/Image; No Display/Image

  A FOREIGN USER FACILITY REPORTED THAT PRIOR TO BEGINNING A PROCEDURE IN WHICH A LUMENIS ACUPULSE 40W CO2 LASER SYSTEM WAS TO BE UTILIZED, THE DISPLAY SCREEN ON THE SYSTEM FROZE AND THE LASER COULD NO LONGER BE USED. UNABLE TO PROCEED WITH THE LASER, THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH AN ALTERNATE DEVICE. NO REPORT OF INJURY WAS RECEIVED, AND THE DEVICE MALFUNCTION DID NOT CAUSE OR CONTRIBUTE TO ANY CHANGE IN THE PATIENT'S CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12765799 ↗
• MalfunctionNov 8, 2021Optical Problem; Optical Problem

  A USER FACILITY REPORTED THAT DURING A PROCEDURE IN WHICH A LUMENIS ACUPULSE 40W CO2 LASER SYSTEM WAS BEING UTILIZED, THE AIMING BEAM DISAPPEARED. UNABLE TO PROCEED WITH THE LASER, THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH AN ALTERNATE DEVICE. NO REPORT OF INJURY WAS RECEIVED, AND THE DEVICE MALFUNCTION DID NOT CAUSE OR CONTRIBUTE TO ANY CHANGE IN THE PATIENT'S CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12765795 ↗
• MalfunctionOct 26, 2021Failure to Deliver Energy; Failure to Deliver Energy

  A USER FACILITY REPORTED THAT A LUMENIS ACUPULSE 40W CO2 LASER SYSTEM PRESENTED ERROR 66 - SCANNER COMMUNICATION ERROR, ON ITS DISPLAY. UNABLE TO PROCEED WITH THE LASER, THE PROCEDURE WAS CANCELLED. NO REPORT OF INJURY WAS RECEIVED, AND NO REPORT WAS RECEIVED ALLEGING THE DEVICE MALFUNCTION CAUSED OR CONTRIBUTED TO ANY CHANGE IN THE PATIENT'S CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12695208 ↗
• MalfunctionAug 19, 2021Optical Problem; Optical Problem

  A USER FACILITY REPORTED THAT DURING A PROCEDURE IN WHICH A LUMENIS ACUPULSE 40W CO2 LASER SYSTEM WAS TO BE UTILIZED, THE AIMING BEAM WAS SCATTERED AND NOT IN FOCUS. AFTER A TWENTY (20) MINUTES DELAY THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH AN ALTERNATE METHOD. NO REPORT OF INJURY WAS RECEIVED, AND THE DEVICE MALFUNCTION DID NOT CAUSE OR CONTRIBUTE TO ANY CHANGE IN THE PATIENT'S CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12340879 ↗
• MalfunctionNov 22, 2020Failure to Deliver Energy; Failure to Deliver Energy

  A FOREIGN USER FACILITY REPORTED THAT PRIOR TO BEGINNING A PROCEDURE IN WHICH A LUMENIS ACUPULSE 40W CO2 LASER SYSTEM WAS TO BE UTILIZED, THE LASER WOULD NOT START UP AND PRESENTED ERROR 48 ON ITS DISPLAY. UNABLE TO PROCEED WITH THE LASER, THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH AN ALTERNATE DEVICE. NO REPORT OF INJURY WAS RECEIVED, AND THE DEVICE MALFUNCTION DID NOT CAUSE OR CONTRIBUTE TO ANY CHANGE IN THE PATIENT'S CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10881562 ↗
• MalfunctionMar 1, 2020Failure to Deliver Energy; Failure to Deliver Energy

  A USER FACILITY REPORTED THAT WHEN THEY WERE SETTING UP THEIR LUMENIS ACUPULSE 40W LASER SYSTEM FOR A MICROLARYNGOSCOPY BRONCHOSCOPY. THEY CONNECTED THE MICROSCOPE AND THE DEVICE STOPPED WORKING. THEY HAD TIGHTENED A SCREW THAT CONNECTED A CABLE AND THOUGHT THEY HAD THINGS SOLVED. HOWEVER, DURING PREP THE DEVICE STOPPED WORKING AND PRESENTED ERROR CODES 41 AND 2. UNABLE TO CONTINUE WITH THE SYSTEM, AN ALTERNATE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE DELAY WAS APPROXIMATELY 15 MINUTES AND THE PROCEDURE COMPLETED WITHOUT INCIDENT OR COMPLICATION. NO REPORT OF PATIENT COMPLICATIONS WAS RECEIVED, AND NO REPORT WAS RECEIVED ALLEGING THE DEVICE MALFUNCTION CAUSED OR CONTRIBUTED TO ANY CHANGE IN THE PATIENT'S CONDITION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9772660 ↗
• MalfunctionJan 7, 2020Failure to Deliver Energy; Failure to Deliver Energy

  A USER FACILITY REPORTED THAT DURING A ROBOTIC CO2 LASER LAPAROSCOPIC PROCEDURE ON A PATIENT'S UTERUS FOR ADHESIONS IN WHICH A LUMENIS ACUPULSE 40W CO2 LASER SYSTEM WAS BEING USED, THE SYSTEM STOPPED LASING. FIBER WAS REPLACED AND IT WORKED FOR A COUPLE MINUTES THEN STOPPED AGAIN. THE THIRD FIBER DID NOT WORK AT ALL. THE LASER SOUNDED LIKE IT WAS FIRING BUT NO ENERGY WAS COMING OUT. AFTER A 10 MINUTE DELAY FOR FIBER EXCHANGE, THE PROCEDURE WAS SUCCESSFULLY COMPLETED MANUALLY. NO REPORT OF INJURY WAS RECEIVED, AND THE DEVICE MALFUNCTION DID NOT CAUSE OR CONTRIBUTE TO ANY CHANGE IN THE PATIENT'S CONDITION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9557148 ↗
• MalfunctionDec 25, 2019Failure of Device to Self-Test; Failure of Device to Self-Test

  A USER FACILITY REPORTED THAT PRIOR TO BEGINNING A PROCEDURE IN WHICH A LUMENIS ACUPULSE 40W CO2 LASER SYSTEM WAS TO BE UTILIZED, THE LASER WOULD NOT START UP AND PRESENTED ERROR 12 (COOLING SYSTEM FLOW SWITCH ERROR) ON ITS DISPLAY. UNABLE TO PROCEED WITH THE LASER, THE PROCEDURE WAS SUCCESSFULLY COMPLETED MANUALLY. NO REPORT OF INJURY WAS RECEIVED, AND THE DEVICE MALFUNCTION DID NOT CAUSE OR CONTRIBUTE TO ANY CHANGE IN THE PATIENT'S CONDITION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9517620 ↗
• MalfunctionOct 6, 2019Communication or Transmission Problem; Communication or Transmission Problem

  A USER FACILITY REPORTED THAT DURING A PROCEDURE IN WHICH A LUMENIS ACUPULSE 40W LASER WAS BEING UTILIZED, THE DISPLAY PRESENTED ERROR 69 - SCANNER POSITION ERROR, AND THE LASER COULD NO LONGER BE USED. THEY REPLACED THE SCANNER CABLE WITH A SPARE THEY HAD IN STOCK AND AFTER A 10 MINUTES DELAY WERE ABLE TO CONTINUE WITH THE PROCEDURE USING THE SAME DEVICE. NO REPORT OF PATIENT COMPLICATIONS WAS RECEIVED, AND NO REPORT WAS RECEIVED ALLEGING THE DEVICE MALFUNCTION CAUSED OR CONTRIBUTED TO ANY CHANGE IN THE PATIENT'S CONDITION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9160275 ↗