NA SU-365-RTRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00816901020272), received between Sep 26, 2018 and Jan 15, 2019 — classified as 1 injury, 1 malfunction.

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

1 FDA recall record name this device's identifier.

4 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.

Recalls naming this device

1. Oct 17, 2018Terminated

   A percentage of the products shipped in Smartscope single-box packaging may exhibit a broken package seal, thus having compromised sterility. There have been two reports of compromised sterility; however, all products packaged in Smartscope single-box packaging are at risk of a compromised product seal. Broken seal pouches compromise sterility and could increase the risk of infection if used.

   Z-0578-2019 · Root cause: Packaging · Recall details · FDA record ↗

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.

• InjuryJan 15, 2019Break

  DURING THE USE OF THE HOLMIUM 365UM LASER FIBER DURING A UROLOGY PROCEDURE, THE LASER FIBER BROKE APPROXIMATELY 12 INCHES FROM THE TIP AS THE FIBER WAS BEING MANIPULATED BY THE PHYSICIAN. A SMALL FLASH WAS SEEN. PROCEDURE WAS STOPPED IMMEDIATELY. SAFETY CHECK COMPLETED. NO PHYSICAL INJURY OR BURNS TO PHYSICIAN OR PATIENT. NEW FIBER WAS USED. SINGLE USE - 365UM BARE HOLMIUM LASER FIBER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8253666 ↗
• MalfunctionSep 26, 2018Sparking; Electrical Shorting

  STARTED TO ACTIVATE THE LASER AND THE CORD SPARKED AND SHORTED. BIOMED AND SUPERVISOR WERE CALLED. LASER MACHINE WAS SWITCHED OUT. CASED COMPLETED WITH NEW MACHINE.

  Patient problems: No Information

  MAUDE report 7909412 ↗

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-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-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