272 SmartScope Laser Fiber FT-0272S-RT-00C-FOR-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00810077630648), received between May 20, 2024 and Jun 12, 2024 — classified as 2 malfunctions.

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

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 18, 2026.

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.

• MalfunctionJun 12, 2024Break; Break

  DURING A UROLOGY PROCEDURE THE FIBER BROKE THAT RESULTED IN A BURN TO THE PHYSICIAN'S GLOVE. THE FIBER "SNAPPED IN HALF" AND "BURNED THE PHYSICIAN'S GLOVE." IT COULD NOT BE VERIFIED HOW THE FIBER BROKE OR IF THE BURN WAS THROUGH THE GLOVE AND CAUSED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19519081 ↗
• MalfunctionMay 20, 2024

  DURING LEFT URETEROSCOPY PROCEDURE , LASER WAS BEING USED, SURGEON NOTIFIED STAFF THAT A SMALL PLASTIC PIECE HAD COME OFF DURING PROCEDURE. PIECE WAS RETRIEVED C-ARM WAS BEING USED FOR PROCEDURE - NO EVIDENCE OF ANY RETAINED PIECES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19351238 ↗