FiberTech® LFS-200-SBRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00816901020531), received between Sep 25, 2019 and Sep 25, 2019 — classified as 1 malfunction.

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

5 other recalls cover devices cleared under the same FDA submission (K050738); they may or may not involve this specific model.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2019Break

  THE FIBER BROKE WHILE THE PHYSICIAN WAS PUSHING THE FIBER THROUGH THE SCOPE. THE BROKEN END OF THE FIBER TOUCHED HIS GLOVE, BURNED THROUGH THE GLOVE AND THE SURFACE OF HIS HAND. THE SPOT WAS VERY PINPOINT, AND DEPTH OF PENETRATION WAS LIMITED DUE TO DISTANCE FROM TISSUE AND LENGTH OF TIME FIBER ACTIVATED. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: Burn, Thermal

  MAUDE report 9116174 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K050738. One submission often covers many models, so check the product and lot details in each record.

• Z-0579-2019 · Oct 17, 2018 · Terminated
  Laser Fiber Assy-Single Use-LFS-550-RT-0.22NA-SMA905-Extension Sleeve Silver-Sterile ETO-Private label: SU-550-RT SmartScope Packaging. The Laser peripherals bare laser fibers,
• Z-0581-2019 · Oct 17, 2018 · Terminated
  Laser Fiber Assy-Single Use-LFS-200-0.22NA-SMA905-Extension Sleeve Silver-Sterile ETO-ForTec Fiber SU-200-TRUE-RT Label Smartscope packaging. The Laser peripherals bare laser f
• Z-0577-2019 · Oct 17, 2018 · Terminated
  Laser Fiber Assy-Single Use-LFS-272-RT-0.22NA-SMA905- Slim Extension Sleeve Silver-Sterile ETO- Private label: SU-200-RT SmartScope Packaging. The Laser peripherals bare laser fib
• Z-0578-2019 · Oct 17, 2018 · Terminated
  Laser Fiber Assy-Single Use-LFS-365-RT-0.22NA-SMA905-Extension Sleeve Silver-Sterile ETO- Private label: SU-365-RT SmartScope Packaging. The Laser peripherals bare laser fibers,
• Z-0580-2019 · Oct 17, 2018 · Terminated
  Laser Fiber Assy-Single Use-LFS-940-RT-0.22NA-SMA905-Extension Sleeve Silver-Sterile ETO-Private label: SU-1000-RT SmartScope Packaging. The Laser peripherals bare laser fibers,