UltraPulse® SurgiTouch™ O.R.Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 07290109141596), received between Dec 25, 2019 and May 14, 2026 — classified as 11 injuries, 1 malfunction.

The most frequently reported specific device problem is “Use of Incorrect Control/Treatment Settings” (3 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryMay 14, 2026Insufficient Device Problem Information

  LUMENIS RECEIVED A MEDWATCH REPORT (MW5185986) DESCRIBING AN ADVERSE EVENT TO PATIENT WHO SUSTAINED INJURY ON HER CHEEKS FOLLOWING TREATMENT BY ULRAPULSE DEVICE.

  Patient problems: Burn(s); Scar Tissue

  MAUDE report 25169161 ↗
• InjuryMay 14, 2026Insufficient Device Problem Information

  LUMENIS RECEIVED A MEDWATCH REPORT (MW5185986) DESCRIBING AN ADVERSE EVENT TO PATIENT WHO SUSTAINED INJURY ON HER CHEEKS FOLLOWING TREATMENT BY ULRAPULSE DEVICE.

  Patient problems: Burn(s); Scar Tissue

  MAUDE report 25168972 ↗
• InjuryDec 1, 2024Use of Incorrect Control/Treatment Settings; Improper or Incorrect Procedure or Method; Use of Incorrect Control/Treatment Settings; Improper or Incorrect Procedure or Method

  LUMENIS RECEIVED AN ADVERSE EVENT REPORT ON A PATIENT WHO SUSTAINED KELOID AT THE DÉCOLLETÉ AREA FOLLOWING TREATMENT BY ULTRAPULSE DEVICE.

  Patient problems: Burn(s)

  MAUDE report 20814861 ↗
• InjuryNov 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LUMENIS RECEIVED AN ADVERSE EVENT REPORT ON A PATIENTS WHO SUSTAINED BURN AND PAIN FOLLOWING TREATMENT BY ULTRAPULSE DEVICE.

  Patient problems: Burn(s)

  MAUDE report 18192577 ↗
• InjuryMay 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LUMENIS RECEIVED AN ADVERSE EVENT REPORT ON EIGHT (8) PATIENTS WHO SUSTAINED BURN FOLLOWING TREATMENT BY LIGHTSHEER DUET DEVICE. SINCE CUSTOMER REPORTED ON 8 INJURED PATIENTS, BUT DID NOT SEND US EVEN ONE INCIDENT FORM, THIS CASE WILL BE TREATED IN ONE SINGLE COMPLAINT.

  Patient problems: Burn(s); Insufficient Information

  MAUDE report 16973306 ↗
• InjuryMay 22, 2023Use of Device Problem; Use of Device Problem

  LUMENIS RECEIVED AN ADVERSE EVENT REPORT ON SEVERAL PATIENTS WHO SUSTAINED SCARS USING DEEPFX AND CPG SCANNERS FOLLOWING TREATMENT BY ULTRAPULSE DEVICE. LUMENIS RECEIVED 4 INCIDENT FORMS IN THIS CASE. THIS COMPLAINT REPRESENTS PATIENT 1 OUT OF 4 WITH INITIALS - (B)(6).

  Patient problems: Scar Tissue

  MAUDE report 16972940 ↗
• InjuryMay 22, 2023Use of Device Problem; Use of Device Problem

  LUMENIS RECEIVED AN ADVERSE EVENT REPORT ON SEVERAL PATIENTS WHO SUSTAINED SCARS USING DEEPFX AND CPG SCANNERS FOLLOWING TREATMENT BY ULTRAPULSE DEVICE. LUMENIS RECEIVED 4 INCIDENT FORMS IN THIS CASE. THIS COMPLAINT REPRESENTS PATIENT 1 OUT OF 4 WITH INITIALS - (B)(6).

  Patient problems: Scar Tissue

  MAUDE report 16972939 ↗
• InjuryJan 18, 2023Use of Incorrect Control/Treatment Settings; Use of Incorrect Control/Treatment Settings

  LUMENIS RECEIVED AN ADVERSE EVENT REPORT ON A PATIENT WHO SUSTAINED BURN FOLLOWING TREATMENT BY CO2 ULTRA PULSE DEVICE.

  Patient problems: Burn(s)

  MAUDE report 16192382 ↗
• InjuryJan 18, 2023Use of Incorrect Control/Treatment Settings; Use of Incorrect Control/Treatment Settings

  LUMENIS RECEIVED AN ADVERSE EVENT REPORT ON A PATIENT WHO SUSTAINED BURN FOLLOWING TREATMENT BY CO2 ULTRA PULSE DEVICE.

  Patient problems: Burn(s)

  MAUDE report 16192381 ↗
• InjuryDec 7, 2020Intermittent Energy Output; Intermittent Energy Output

  LUMENIS RECEIVED A REPORT OF AN ADVERSE EVENT FOLLOWING TREATMENT WITH ULTRAPULSE TOTALFX. THE PATIENT WAS AWAKENED DURING TREATMENT AND WAS RESCHEDULED FOR A DIFFERENT TIME.

  Patient problems: Awareness During Anesthesia

  MAUDE report 10957786 ↗
• InjuryDec 1, 2020Disconnection; Disconnection

  LUMENIS RECEIVED AN ADVERSE EVENT REPORT ON A PATIENT WHO WAS TREATED UNDER ANESTHESIA AND WAS AWAKED DUE TO IMPROPRIETY HANDPIECE (DEEP FX) THAT STOPPED WORKING DURING A PROCEDURE FOLLOWING TREATMENT WITH ULTRAPULSE TOTAL DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10927005 ↗
• MalfunctionDec 25, 2019Failure of Device to Self-Test; Failure of Device to Self-Test

  A USER FACILITY REPORTED THAT AT THE START OF A PROCEDURE, IN WHICH A LUMENIS ULTRAPULSE TOTAL FX WAS TO BE USED, THE LASER DISPLAYED ERROR CODE 23 "POST FAILED" AND ERROR CODE 81 "COOLANT FLOW INADEQUATE". UNABLE TO CONTINUE WITH THE DEVICE, THE PATIENT WAS AWAKENED FROM GENERAL ANESTHESIA AND THE CASE NEEDED TO BE RESCHEDULED. 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 9517653 ↗