Slimline 550 FiberRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07290109140025), received between Apr 13, 2021 and Aug 24, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 24, 2022Break; Smoking; Use of Device Problem; Break; Smoking; Use of Device Problem

  IT WAS REPORTED THAT, DURING PREPARATION FOR A CERVICAL CONIZATION PROCEDURE, THIS FIBER WAS LEFT ON A CLOTH THAT HAD BEEN PLACED ON THE PATIENT. THE CONSOLE SCREEN STATUS REMAINED IN READY MODE WHILE THE LASER FIBER WAS OUTSIDE THE PATIENT. THE CLOTH SUDDENLY CAUGHT FIRE; THE FIRE WAS QUICKLY EXTINGUISHED AND THERE HAS NO HARM TO THE PATIENT OR MEDICAL STAFF. THE PROCEDURE WAS COMPLETED WITH THE SAME FIBER. IT IS BELIEVED THAT THE SYSTEM WAS MISTAKENLY ACTIVATED, LEADING TO THE FIRE. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE HANDPIECE SHOWED BURN MARKS, INDICATING THAT THE LASER HAD BEEN FIRED INSIDE THE HANDPIECE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15285739 ↗
• MalfunctionOct 11, 2021Failure to Deliver Energy; Failure to Deliver Energy

  LUMENIS WAS INFORMED BY A FOREIGN DISTRIBUTOR THAT A FOREIGN USER FACILITY REPORTED THAT DURING A HOLEP PROCEDURE IN WHICH A LUMENIS PULSE 120H LASER SYSTEM WITH A LUMENIS SLIMLINE 550¿ WAS BEING UTILIZED, "45 MINUTES AFTER THE PROCEDURE BEGAN, THE MACHINE MADE WEIRD NOISES WHILE LASING". THE USER ELECTED TO STOP AND THE REMAINDER OF THE PROCEDURE WAS SUCCESSFULLY COMPLETED BY A TURP PROCEDURE. 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 12603813 ↗
• MalfunctionApr 13, 2021Overheating of Device; Overheating of Device

  A FOREIGN USER FACILITY REPORTED THAT DURING A PULMONARY PROCEDURE IN WHICH A LUMENIS VERSAPULSE POWERSUITE 80/100 LASER SYSTEM WITH A LUMENIS SLIMLINE 550¿ WAS BEING UTILIZED, SPARKS/FLAME BACKFIRED LEADING TO IRREPARABLE SCOPE DAMAGE. THE FIBER AND SCOPE WERE REMOVED FROM THE PATIENT AND AFTER A 15 MINUTES DELAY THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11654905 ↗