Slimline SIS 550 FiberRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07290109140247), received between Apr 26, 2024 and Feb 5, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

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.

• MalfunctionFeb 5, 2025Break; Break

  IT WAS REPORTED THAT, THE DEBRIS SHIELD GOT BURNT DURING A PROCEDURE. THE FIBER AND THE DEBRIS SHIELD WERE REPLACED, AND IMMEDIATELY AFTER RESTARTING THE PROCEDURE, AN ABNORMAL NOISE WAS HEARD COMING FROM THE FIBER CONNECTION POINT, AND THEN THE FIBER BROKE AT THE CONNECTOR. THE PROCEDURE WAS COMPLETED USING ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS. THIS COMPLAINT REFERS TO THE FIBER THAT BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21313174 ↗
• MalfunctionApr 26, 2024Break; Break

  IT WAS REPORTED THAT DURING A PERCUTANEOUS NEPHROLITHOTOMY PROCEDURE FOR KIDNEY STONES, THE FIBER SNAPPED IN HALF INSIDE THE PATIENT. DUE TO THIS, THE PROCEDURE WAS COMPLETED USING AN ALTERNATE FIBER. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19197444 ↗