Lumenis Pulse 50HRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07290109140537), received between Jul 17, 2019 and Mar 17, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Optical Problem” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 17, 2022Optical Problem; Optical Problem

  A USER FACILITY REPORTED THAT DURING A LITHOTRIPSY PROCEDURE IN WHICH A LUMENIS PULSE 50 WAS BEING UTILIZED, THE AIMING BEAM DISAPPEARED. THE USER FACILITY TRIED TO TROUBLESHOOT FOR FIFTEEN (15) MINUTES, BUT THE LASER COULD NO LONGER BE USED. UNABLE TO COMPLETE THE PROCEDURE, THE PATIENT WAS AWAKENED FROM GENERAL ANESTHESIA AND THE CASE NEEDED TO BE RESCHEDULED. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 13797934 ↗
• MalfunctionJul 17, 2019Overheating of Device; Overheating of Device

  LUMENIS RECEIVED USER FACILITY SUBMITTED MEDWATCH REPORT (3901330000-2019-8042) IN WHICH THE DESCRIPTION READS "WHILE THE SURGEON WAS PERFORMING LASER LITHOTRIPSY, THE LASER FIBER CONNECTOR OVERHEATED. THE LASER WAS PUT ON STANDBY AND THE LASER FIBER DISCONNECTED FROM THE LASER MACHINE. THE SURGEON DID NOT PROCEED WITH THE LASER LITHOTRIPSY FOR SAFETY REASONS". THE MEDWATCH REPORT INDICATES THAT A FIBER WHOSE CONNECTOR OVERHEATED WAS A NON-LUMENIS FIBER. NO REPORT OF INJURY WAS RECEIVED, NOR REPORT THAT THE MALFUNCTION CAUSED OR CONTRIBUTED TO ANY CHANGE IN THE PATIENT'S CONDITION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8797800 ↗