Slimline SIS 200 FiberRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 07290109140223), received between Feb 25, 2020 and Sep 18, 2025 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2025Power Problem; Power Problem

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE FIBER WAS CONNECTED, AND IT STOPPED WORKING. DUE TO THIS, THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WERE NO PATIENT COMPLICATIONS. ANALYSIS OF THE RETURNED FIBER REVEALED NO LIGHT WAS EXITING THROUGH CONNECTOR INDICATING AN INTERNAL CONNECTOR FRACTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23088752 ↗
• MalfunctionJul 10, 2025Break; Break

  IT WAS REPORTED THAT DURING A URETEROSCOPY PROCEDURE, THE FIBER POPPED WHILE USING IT AND WAS NOT SALVAGEABLE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITH NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22472884 ↗
• MalfunctionSep 21, 2024Defective Device; Defective Device

  IT WAS REPORTED THAT DURING ROUTINE REPROCESSING OF THE REUSABLE FIBER, THE TECH NOTICED LASER BURNS AND BLACK SPOTS ON THE FIBER. A SECOND FIBER WAS USED TO COMPLETE THE PROCEDURE WITH NO PATIENT COMPLICATIONS. ANALYSIS OF THE RETURNED DEVICE IDENTIFIED A FIBER CONNECTOR FRACTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20275490 ↗
• MalfunctionApr 22, 2024Break; Break

  IT WAS REPORTED THAT DURING RETROGRADE INTRARENAL SURGERY PROCEDURE, THE FIBER BROKE IN TWO AFTER IT WAS STERILIZED TWICE. DUE TO THIS, THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19159959 ↗
• MalfunctionOct 31, 2023Break; Power Problem; Break; Power Problem

  IT WAS REPORTED THAT DURING THE PROCEDURE, IT WAS FOUND THAT BOTH THE FIBER AND DEBRIS SHIELD WERE BROKEN. THE FIBER WAS BROKEN AT THE FIBER TIP, AND THEN THE FIBER STOPPED WORKING. IT WAS NOTED THERE WERE NO DEVICE ISSUE WITH CONNECTING THE FIBER TO THE CONSOLE AND THE FIBER WAS RECOGNIZED BY THE CONSOLE WHEN IT WAS CONNECTED. THIS REPORT IS FOR THE FIBER BREAK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18039377 ↗
• MalfunctionSep 5, 2023Break; Defective Device; Break; Defective Device

  IT WAS REPORTED THAT DURING A URETEROSCOPY PROCEDURE FOR URINARY STONE REMOVAL, THE FIBER MADE A POPPING SOUND AND DID NOT WORK. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17686299 ↗
• MalfunctionMar 5, 2020Material Fragmentation; Material Fragmentation

  A USER FACILITY REPORTED THAT DURING A PROCEDURE IN WHICH A LUMENIS SLIMLINE SIS 200 FIBER WAS BEING UTILIZED , THE FIBER TIP BROKE IN THE PATIENT'S KIDNEY. NO REPORT OF PATIENT INJURY WAS RECEIVED, NOR WAS THE EVENT REPORTED TO HAVE CAUSED OR CONTRIBUTED TO ANY CHANGE IN THE PATIENT'S CONDITION. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED BY USE OF A NEW FIBER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9792140 ↗
• MalfunctionFeb 25, 2020Material Fragmentation; Material Fragmentation

  A FOREIGN USER FACILITY REPORTED THAT DURING A TUL PROCEDURE IN WHICH A LUMENIS SLIMLINE 200 REUSABLE FIBER WAS BEING UTILIZED , 10MM OF THE FIBER TIP BROKE AND REMAINED INSIDE THE KIDNEY. THE FRAGMENT WAS REMOVED USING A BASKET FORCEPS. NO REPORT OF PATIENT INJURY WAS RECEIVED, AND NO REPORT THAT THE EVENT CAUSED OR CONTRIBUTED TO ANY CHANGE IN THE PATIENT'S CONDITION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9748993 ↗