SlimLine™ Slimline™ EZ SIS 200Recalls & reported problems

Summary

The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 07290109147048), received between Apr 21, 2023 and Sep 28, 2026 — classified as 4 injuries, 35 malfunctions.

The most frequently reported specific device problem is “Break” (32 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 25 most recent of 39 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50919948 ↗
• MalfunctionMar 16, 2026Break

  IT WAS REPORTED THAT DURING A URETEROSCOPY PROCEDURE, THE FIBER SPLIT IN TWO INSIDE THE DISPOSABLE FLEXIBLE URETEROSCOPE. THE PHYSICIAN REMOVED THE PORTION OF THE FIBER THAT HAD DETACHED INSIDE THE PATIENT. THERE WERE NO PROCEDURE AND PATIENT OUTCOME REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24612470 ↗
• MalfunctionMar 16, 2026Break

  IT WAS REPORTED THAT DURING A LASER URETEROSCOPY PROCEDURE, THE LASER FIBER SPLIT IN TWO INSIDE THE URETERORENOSCOPE, AND ONE OF THE SECTIONS OF THE FIBER WAS EXPELLED WHILE THE LASER WAS SWITCHED ON. THE SURGEON TURNED OFF THE LASER. THE SECOND SECTION OF THE FIBER WAS RETRIEVED BY THE SURGEON AND REMOVED FROM THE PATIENT. PATIENT/PROCEDURE OUTCOME UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24605978 ↗
• MalfunctionFeb 19, 2026Break

  IT WAS REPORTED THAT DURING A URETEROSCOPY PROCEDURE, THE LASER FIBER SPLIT IN TWO INSIDE THE URETEROSCOPE, AND ONE PART OF THIS FIBER WAS EJECTED FROM THE DMC WHILE THE LASER REMAINED SWITCHED ON. THE SURGEON STOPPED THE LASER, AND THE SECOND PART OF THE FIBER WAS RETRIEVED BY THE SURGEON AND REMOVED FROM THE PATIENT. REPORTEDLY, THERE WERE TWO DEVICES AFFECTED, AND THERE WERE NO CONSEQUENCES. THE PROCEDURE OUTCOME WAS NOT PROVIDED. THIS REPORT IS FOR THE SECOND FIBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24393988 ↗
• InjuryFeb 19, 2026Break

  IT WAS REPORTED THAT DURING A LITHOTRIPSY PROCEDURE, THE HOLMIUM LASER FIBER UNEXPECTEDLY FRACTURED, RESULTING IN AN INJURY TO THE SURGEONS FINGER. THE UNIT WAS IMMEDIATELY TURNED OFF FOR INSPECTION, DURING WHICH DAMAGE TO THE LASER PROTECTION LENS WAS OBSERVED. THE PHYSICIAN PROMPTLY PAUSED THE PROCEDURE, STEPPED AWAY FROM THE OPERATING TABLE, RINSED THE INJURED FINGER AND DISINFECTED THE AREA. AFTER THAT, COMPLETED A NEW SURGICAL SCRUB AND CONTINUED THE OPERATION. THE HOLMIUM LASER MACHINE AND FIBER WERE REPLACED, AND THE FRACTURED FIBER WAS RETAINED.

  Patient problems: Burn(s)

  MAUDE report 24390887 ↗
• MalfunctionFeb 19, 2026Break

  IT WAS REPORTED THAT DURING A URETEROSCOPY PROCEDURE, THE LASER FIBER SPLIT IN TWO INSIDE THE URETEROSCOPE, AND ONE PART OF THIS FIBER WAS EJECTED FROM THE DMC WHILE THE LASER REMAINED SWITCHED ON. THE SURGEON STOPPED THE LASER, AND THE SECOND PART OF THE FIBER WAS RETRIEVED BY THE SURGEON AND REMOVED FROM THE PATIENT. REPORTEDLY, THERE WERE TWO DEVICES AFFECTED, AND THERE WERE NO CONSEQUENCES. THE PROCEDURE OUTCOME WAS NOT PROVIDED. THIS REPORT IS FOR THE FIRST FIBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24389226 ↗
• MalfunctionJan 27, 2026Break; Nonstandard Device

  IT WAS REPORTED THAT DURING A HOLMIUM LASER LITHOTRIPSY PROCEDURE FOR URETERAL CALCULUS, THE FIBER GOT FRACTURED. 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 24190365 ↗
• MalfunctionJan 27, 2026Break; Nonstandard Device

  IT WAS REPORTED THAT DURING A HOLMIUM LASER LITHOTRIPSY PROCEDURE FOR URETERAL CALCULUS, THE FIBER GOT FRACTURED. 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 24190361 ↗
• MalfunctionJan 27, 2026Break; Nonstandard Device

  IT WAS REPORTED THAT DURING A HOLMIUM LASER LITHOTRIPSY PROCEDURE FOR URETERAL CALCULUS, THE FIBER GOT FRACTURED. 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 24190352 ↗
• MalfunctionJan 13, 2026Break

  IT WAS REPORTED THAT DURING A UROLOGICAL STONE LITHOTRIPSY PROCEDURE, THERE WAS A FIBER TIP BREAK, RENDERING THE SINGLE USE FIBER UNUSABLE. THE FIBER DID NOT DETACH BUT HAD VISIBLE FRACTURES. THE USE OF THAT FIBER WAS IMMEDIATELY DISCONTINUED, AND A NEW FIBER WAS USED. THE PROCEDURE WAS COMPLETED USING THE SECOND FIBER WITHOUT PATIENT COMPLICATIONS. THIS CAUSED A DELAY IN SURGICAL PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24059926 ↗
• MalfunctionDec 29, 2025Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT PRIOR TO A TRANSURETHRAL LITHOTOMY PROCEDURE, THERE WAS A DEFECTIVE SEAL ON FIBER INDIVIDUAL PACKAGE. THE PROCEDURE WAS COMPLETED WITH ANOTHER FIBER WITHOUT PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23907819 ↗
• MalfunctionDec 11, 2025Break; Overheating of Device; Break; Overheating of Device

  IT WAS REPORTED THAT DURING A PROCEDURE, THE FIBER BROKE APPROXIMATELY 30 - 40 CM FROM THE TIP AND SEPARATED INTO PIECES. THE PHYSICIAN REPORTED FEELING HEAT AROUND THE HAND DURING THE EVENT. NO FRAGMENTS FELL INTO THE BODY SINCE THOSE REMAINED INSIDE THE RIGID SCOPE AND WERE REMOVED TOGETHER WITH THE SCOPE. THE FIBER WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT PATIENT COMPLICATIONS. AFTER THE PROCEDURE, THE BROKEN SECTION OF THE REPLACED FIBER WAS COMPARED AND NOTED TO HAVE A DIFFERENT COLOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23775638 ↗
• MalfunctionNov 26, 2025Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE FIBER COULD NOT EMIT LASER FOR THE FIRST TIME IN USE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WERE NO PATIENT COMPLICATIONS. ANALYSIS OF THE RETURNED DEVICE IDENTIFIED A FIBER BREAK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23659197 ↗
• MalfunctionSep 18, 2025Break; Break

  IT WAS REPORTED THAT DURING LITHOTRIPSY PROCEDURE, THE FIBER BROKE. THE PROCEDURE WAS COMPLETED USING A SECOND FIBER. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23091999 ↗
• MalfunctionSep 16, 2025Break; Break

  IT WAS REPORTED THAT DURING A HOLMIUM LASER LITHOTRIPSY, THE FIBER FRACTURED AFTER FIVE MINUTES OF USE. THE FRACTURED FIBER WAS REMOVED AND THE FIBER TIP REMAINED ATTACHED. THE PROCEDURE WAS COMPLETED WITH ANOTHER FIBER WITHOUT PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23064981 ↗
• MalfunctionJun 20, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING PREPARATION FOR A FLEXIBLE URETEROSCOPY LITHOTRIPSY PROCEDURE, THE FIBER WAS CONNECTED BUT THE INDICATOR LIGHT COULD NOT BE TURNED ON AND THE FIBER COULD NOT WORK. THE PROCEDURE WAS COMPLETED WITH ANOTHER FIBER WITHOUT PATIENT COMPLICATIONS. THE FIBER RETURNED AND THE ANALYSIS IDENTIFIED THAT THERE WAS AN INTERNAL CONNECTOR FRACTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22299687 ↗
• MalfunctionJun 20, 2025Separation Problem; Separation Problem

  IT WAS REPORTED THAT THE FIBER FELL OFF FROM THE CONNECTOR DURING THE FLEXIBLE URETEROSCOPY LITHOTRIPSY PROCEDURE, SO IT COULD NOT BE USED NORMALLY. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22297621 ↗
• MalfunctionMay 22, 2025Break; Break

  IT WAS REPORTED THAT THE FIBER BROKE AFTER TWO MINUTES OF USE, RENDERING IT UNUSABLE. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE PATIENT OUTCOME TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22074538 ↗
• MalfunctionApr 1, 2025Break; Break

  IT WAS REPORTED THAT DURING A KIDNEY STONE REMOVAL PROCEDURE, THE FIBER BROKE. THE PROCEDURE WAS COMPLETED WITH ANOTHER FIBER WITHOUT PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21748538 ↗
• MalfunctionMar 26, 2025Break; Break

  IT WAS REPORTED THAT DURING A TRANSURETHRAL LASER LITHOTRIPSY PROCEDURE, THE FIBER BODY WAS DISCOVERED TO HAVE FRACTURED. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME FIBER WITH NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21704120 ↗
• MalfunctionMar 18, 2025Break; Break

  IT WAS REPORTED THAT DURING AN URETEROSCOPY PROCEDURE, THE FIBER BROKE AT THE GLASS TIP. THE USER REMOVED THE BROKEN SECTION SAFELY AND CONTINUED LASERING. AFTER A FEW MINUTES THE GREEN AIMING BEAM DISAPPEARED, AND DESPITE ADJUSTING THE LASER SETTINGS, IT DID NOT RETURN. THE PROCEDURE WAS COMPLETED USING ANOTHER FIBER. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21631518 ↗
• MalfunctionFeb 19, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING A LITHOTRIPSY PROCEDURE WHEN THE FIBER WAS USED, THERE WAS NO INDICATOR LIGHT IN THE FRONT SECTION OF THE FIBER, AND AFTER INSPECTION IT WAS FOUND THAT THE FIBER WAS DISCONNECTED IN THE SOFT LENS. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THE PATIENT CONDITION FOLLOWING PROCEDURE WAS STABLE. AFTER THAT, THE FIBER WAS RETURNED FOR EVALUATION AND THE ANALYSIS DETERMINED THAT THE FIBER BODY WAS BROKEN INTO TWO PIECES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21411231 ↗
• MalfunctionOct 10, 2024Defective Device; Defective Device

  IT WAS REPORTED THAT DURING PROCEDURE THE FIBER WAS DAMAGE WITHIN THE TUBE. THE LASER WAS ABLE TO CROSS THOUGH THE ENTIRE FIBER. THE PROCEDURE WAS COMPLETED USING THE SAME FIBER. THERE WERE NO PATIENT COMPLICATIONS REPORTED. ANALYSIS OF THE RETURNED FIBER IDENTIFIED THAT THE TIP WAS BROKEN AND PRESENTED BURNT MARKS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20421027 ↗
• MalfunctionSep 24, 2024Break; Break

  IT WAS REPORTED THAT DURING PREPARATION FOR A HOLMIUM LASER LITHOTRIPSY PROCEDURE, THE FIBER TIP BROKE. THE PROCEDURE WAS COMPLETED USING ANOTHER FIBER. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20295405 ↗
• MalfunctionSep 11, 2024Break; Break

  IT WAS REPORTED THAT, DURING A HOLMIUM LASER LITHOTRIPSY PROCEDURE, THE FIBER BROKE IN TWO PIECES. THE CONSOLE WAS FUNCTIONING AS EXPECTED, AND THE DEBRIS SHIELD WAS CONFIRMED TO BE INTACT. A SECOND FIBER WAS CHOSEN, AND THE PROCEDURE WAS COMPLETED WITHOUT PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20197091 ↗