Xpeeda DSL FiberRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07290109140278), received between Feb 20, 2020 and Feb 18, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 16, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 18, 2025Break; Break

  IT WAS REPORTED THAT DURING A CYSTOLITHOLAPAXY PROCEDURE, THE STAFF NOTICED THAT THE FIBER WIRE BROKE IN HALF. WHEN THE FIBER BROKE HIT THE PATIENT DRAPE AND BURNED THE DRAPE. THERE WAS A BARRIER BETWEEN THE PATIENT AND THE DRAPE, THEREFORE, THERE WAS NO PATIENT HARM. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE METHOD WITHOUT PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21406369 ↗
• MalfunctionJun 12, 2024Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FIBER TIP BROKE OFF WHEN INTRODUCED TO THE WORKING CHANNEL. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19519458 ↗
• MalfunctionNov 9, 2023Break; Break

  IT WAS REPORTED THAT THE LASER FIBER CAP BROKE DURING THE HOLMIUM LASER ENUCLEATION OF THE PROSTATE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18101196 ↗
• MalfunctionJun 28, 2023Break; Break

  IT WAS REPORTED THAT THE FIBER DETERIORATED DURING THE PROCEDURE AND AT THE END OF THE PROCEDURE, THE TIP DETACHED. THE PROCEDURE WAS COMPLETED WITHOUT ANY PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17221913 ↗
• MalfunctionNov 17, 2022Break; Break

  IT WAS REPORTED THAT DURING A PROSTATE ABLATION PROCEDURE, THE FIBER TIP BROKE OFF INSIDE THE PATIENT BLADDER. THE PROCEDURE WAS COMPLETED WITH ANOTHER FIBER WITHOUT PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15813313 ↗
• MalfunctionOct 19, 2022Break; Thermal Decomposition of Device; Detachment of Device or Device Component; Break; Thermal Decomposition of Device; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROCEDURE THE LASER TIP FELL OFF AND EXPLODED INSIDE THE PATIENT. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15633123 ↗
• MalfunctionFeb 20, 2020Material Fragmentation; Material Fragmentation

  A USER FACILITY REPORTED THAT DURING A PROCEDURE IN WHICH A LUMENIS XPEEDA FIBER WAS BEING UTILIZED , THE TIP OF THE FIBER BROKE OFF IN THE PATIENT. THE TIP WAS RETRIEVED AND A NEW FIBER WAS USED TO COMPLETE THE CASE. NO REPORT OF PATIENT INJURY WAS RECEIVED, AND THE EVENT DID NOT CAUSE OR CONTRIBUTE TO ANY CHANGE IN THE PATIENT'S CONDITION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9731660 ↗