Slimline EZ SIS 200 FiberRecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 07290109140193), received between Sep 22, 2022 and Apr 10, 2025 — classified as 1 injury, 13 malfunctions.

The most frequently reported specific device problem is “Break” (9 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 10, 2025Break; Power Problem; Break; Power Problem

  IT WAS REPORTED THAT DURING A URETEROSCOPY PROCEDURE, THE FIBER BROKE AND THERE WAS NO ENERGY. THE PROCEDURE WAS COMPLETED USING ANOTHER FIBER. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21822090 ↗
• MalfunctionDec 19, 2023Break; Break

  IT WAS REPORTED THAT THE FIBER BROKE AT THE BODY WHILST INSIDE SCOPE, NO DEFLECTION ON SCOPE. THE FIBER AND THE BROKEN PART WERE REMOVED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING ANOTHER DEVICE, WITH NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18360827 ↗
• MalfunctionOct 9, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE FIBER TIP CAME OFF WHEN USING THE FIBER. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17896056 ↗
• MalfunctionOct 5, 2023Break; Break

  IT WAS REPORTED THAT DURING A LASER LITHOTRIPSY, THE FIBER TIP CAME OFF BUT DID NOT FALL INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED USING ANOTHER FIBER WITHOUT PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17877130 ↗
• MalfunctionJul 6, 2023Break; Break

  IT WAS REPORTED THAT DURING A LITHOTRIPSY PROCEDURE TO STONE DUST A KIDNEY STONE, THE FIBER BROKE. THE FIBER WAS REPLACED, AND THE PROCEDURE WAS COMPLETED WITHOUT PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17274723 ↗
• MalfunctionJun 19, 2023Defective Device; Defective Device

  IT WAS REPORTED THAT DURING A PROCEDURE, THE FIBER HAD NO AIMING BEAM. THE FIBER WAS REPLACED TO CONTINUE WITH THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITHOUT PATIENT COMPLICATIONS. THE FIBER WAS RETURNED, AND ANALYSIS FOUND THERE WAS A CONNECTOR FRACTURE; THEREFORE, MEETING REPORTING CRITERIA BASED ON THIS FINDING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17159967 ↗
• MalfunctionMay 19, 2023Firing Problem; Firing Problem

  IT WAS REPORTED THAT DURING A PROCEDURE, THE LASER BEAM OF THIS FIBER WAS NOT BEING IRRADIATED. THE FIBER WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. ANALYSIS OF THE RETURNED FIBER IDENTIFIED A CONNECTOR FRACTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16959592 ↗
• MalfunctionApr 21, 2023Break; Defective Device; Break; Defective Device

  IT WAS REPORTED THAT 3 FIBERS WERE UTILIZED DURING A KIDNEY STONE URETEROSCOPE PROCEDURE. DURING THE PROCEDURE, THE TIP OF THE FIRST FIBER BROKE OFF, AND DEGRADED AT LOW POWER AFTER 30 SECOND OF FIBER USE. THE FIRST FIBER WAS REPLACED, AND DURING LASING WITH THE SECOND FIBER, THE TIP OF THE FIBER BROKE OFF AND DEGRADED AFTER 10 MINUTES OF FIBER USED. THE SECOND FIBER WAS REPLACED, AND DURING LASING WITH THE THIRD FIBER, THE TIP OF THE FIBER ALSO BROKE OFF AND DEGRADED AFTER 5 MINUTES OF FIBER USE. THE PHYSICIAN THEN REQUESTED A DIFFERENT LASER CONSOLE TO COMPLETE THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH ANOTHER LASER WITHOUT PATIENT COMPLICATIONS. THIS REPORT CORRESPONDS TO THE SECOND FIBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16788840 ↗
• MalfunctionApr 17, 2023Break; Break

  IT WAS REPORTED THAT DURING A PROCEDURE, THE FIBER BROKE. THERE WAS NO PATIENT COMPLICATION RELATED TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16753020 ↗
• InjuryMar 15, 2023Break; Break

  IT WAS REPORTED THAT DURING URETEROSCOPY, THE FIBER BROKE IN THE PHYSICIAN'S HAND AND CAUSED A BURN TO THE RIGHT THUMB. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE PROCEDURE OUTCOME TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: Burn(s)

  MAUDE report 16550116 ↗
• MalfunctionMar 9, 2023Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, DURING A URETEROSCOPY PROCEDURE, THE FIBER SNAPPED AND BROKE. ANOTHER FIBER WAS USED IN ORDER TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16512167 ↗
• MalfunctionFeb 20, 2023Defective Device; Device Displays Incorrect Message; Defective Device; Device Displays Incorrect Message

  IT WAS REPORTED THAT DURING TRANSURETHRAL LITHOTRIPSY (TUL) PROCEDURE, THE LASER LIGHT WAS UNABLE TO RADIATE, AND AN ERROR MESSAGE DISPLAYED INDICATING TO CHECK THE DEBRIS SHIELD. THE PROCEDURE WAS COMPLETED AFTER REPLACING THE DEBRIS SHIELD AND THE FIBER WITHOUT PATIENT COMPLICATIONS. ANALYSIS OF THE RETURNED FIBER IDENTIFIED FIBER BODY BREAK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16406158 ↗
• MalfunctionNov 28, 2022Defective Device; Device Displays Incorrect Message; Defective Device; Device Displays Incorrect Message

  IT WAS REPORTED THAT, DURING A TRANSURETHRAL LITHOTRIPSY PROCEDURE, THE LASER LIGHT WAS UNABLE TO RADIATE AND AN ERROR MESSAGE DISPLAYED INDICATING TO CHECK THE DEBRIS SHIELD; THE BURN OF THE DEBRIS SHIELD WAS CONFIRMED. THE PROCEDURE WAS COMPLETED AFTER REPLACING THE DEBRIS SHIELD AND FIBER WITHOUT PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15869434 ↗
• MalfunctionSep 22, 2022Break; Break

  IT WAS REPORTED THAT DURING THE PROCEDURE THE FIBER SNAPPED. A SECOND FIBER WAS USED TO COMPLETE THE PROCEDURE WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15466881 ↗