NA NV0635Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00816901020470), received between Jan 19, 2023 and Jan 19, 2023 — 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.

• MalfunctionJan 19, 2023Break; Break

  EVLA PROCEDURE IN THE LEFT SAPHENOUS VEIN. THIS WAS THE FIRST USE OF THIS FIBER. 15CM OF THE VEIN WERE ABLATED PRIOR TO THE FIBER FRACTURE. FIBER REMNANTS REMAIN IN THE PATIENT'S LEG. THEY ARE SEEING VASCULAR SURGERY TO ADDRESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16206361 ↗

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-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-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-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-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,
• 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,