NA SU-200-TRUE-RTRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00816901020326), received between Nov 10, 2022 and Nov 10, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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-0581-2019 · Root cause: Packaging · Recall details · FDA record ↗

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.

• MalfunctionNov 10, 2022Difficult to Remove; Detachment of Device or Device Component

  PHYSICIAN PERFORMING URETEROSCOPY FOR LEFT URETERAL STONE AND USING 272 HOLMIUM LASER FIBER. MID PROCEDURE, SURGEON NOTED LASER TIP NO LONGER INTACT. THE SMALL, DETACHED TIP WAS BRIEFLY SEEN ON THE MONITOR, BUT WITH THE WATER RUNNING, IT WAS QUICKLY OUT OF SIGHT. THE BROKEN TIP WAS NOT RECOVERED. UROCATCH BAG SEARCHED BY RN AND NO TIP VISUALIZED. THE REMAINING LONG LASER FIBER WAS REMOVED FROM THE PATIENT AND ISOLATED IN ITS ORIGINAL PACKAGING. A NEW LASER FIBER WAS OPENED, INSPECTED, AND USED TO PERFORM THE REMAINING PROCEDURE WITHOUT COMPLICATION. MD AWARE THAT ORIGINAL LASER FIBER TIP WAS NOT RECOVERED. NO PATIENT COMPLICATION OBSERVED.

  Patient problems: Foreign Body In Patient

  MAUDE report 15770326 ↗

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-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-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,