Lumenis Pulse 120H (REF GA-2003476)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07290109145457), received between Jan 19, 2023 and Sep 18, 2026 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2026Communication or Transmission Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50820308 ↗
• MalfunctionAug 7, 2026Nonstandard Device

  It was reported that during a holmium laser enucleation of the prostate to treat benign prostatic hyperplasia, the console's blast shield sustained consecutive burn damage. There were no patient complications. However, the procedure was cancelled with the patient already under anesthesia.This event is being reported for aborted/cancelled procedure with a patient under anesthesia or sedation status unknown.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50180359 ↗
• InjuryOct 16, 2024Device Displays Incorrect Message; Device Displays Incorrect Message

  IT WAS REPORTED THAT AN ERROR DISPLAYED WHEN OUTPUT WAS ATTEMPTED. AFTER FIFTEEN MINUTES, THE PROCEDURE RESUMED AND COULD BE SUCCESSFULLY COMPLETED WITH THE SAME DEVICE. AFTER THE PROCEDURE, THE PATIENT HAD A FEVER AND DEVELOPED SEPSIS. TO TREAT THE INFECTION, THE PATIENT HAD TO TAKE ANTIBIOTICS, AND HOSPITALIZATION WAS EXTENDED.

  Patient problems: Fever; Sepsis

  MAUDE report 20466543 ↗
• MalfunctionMar 26, 2024Device Displays Incorrect Message; Device Displays Incorrect Message

  IT WAS REPORTED THAT DURING PROCEDURE THE CONSOLE DISPLAYED ERROR CODE 282 AND THE DEVICE CANNOT BE USED. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE PATIENT OUTCOME TO DATE, DESPITE GOOD FAITH EFFORTS. THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER ANESTHESIA OR SEDATION IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18980905 ↗
• MalfunctionNov 8, 2023Defective Device; Defective Device

  IT WAS REPORTED THAT DURING PROCEDURE IT WAS FOUND THAT THE DEBRIS SHIELD WAS BURNT. THE ISSUE ALSO OCCURRED AFTER REPLACING THE FIBER AND SHIELD AT THE SAME TIME, THEREFORE IT IS SUSPECTED THAT THERE IS A PROBLEM WITH THE CONSOLE. THE PROCEDURE WAS CANCELLED. NO PATIENT COMPLICATIONS WERE REPORTED. THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER ANESTHESIA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18095746 ↗
• MalfunctionJan 19, 2023Device Displays Incorrect Message; Adverse Event Without Identified Device or Use Problem; Device Displays Incorrect Message; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, PRIOR TO THE PROCEDURE, THIS CONSOLE ISSUED ERROR 87 WHICH INDICATES AN ISSUE WITH TWO OR MORE BRICKS. IRRADIATION WAS NOT POSSIBLE, SO THE PROCEDURE WAS RESCHEDULED FOR THE FOLLOWING MONTH. THE PATIENT HAD ALREADY BEEN SEDATED. NO PATIENT COMPLICATIONS WERE REPORTED. THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER ANESTHESIA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16206363 ↗