Slimline EZ SIS 365 FiberRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07290109140209), received between Feb 4, 2020 and Jan 19, 2024 — classified as 3 injuries, 3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJan 19, 2024Break; Break

  IT WAS REPORTED THAT DURING A PROCEDURE, THE DISTAL END OF THE LASER FIBER BROKE OFF. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE PATIENT AND PROCEDURE OUTCOME TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18544980 ↗
• InjuryJan 9, 2024Defective Device; Defective Device

  IT WAS REPORTED THAT DURING A PROCEDURE, THERE WAS A DEVICE MALFUNCTION AND DUE TO THIS, THE PHYSICIAN GOT INJURED. THE PATIENT AND PROCEDURE OUTCOME ARE UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 18476374 ↗
• MalfunctionSep 17, 2023Break; Break

  IT WAS REPORTED THAT DURING AN URETEROSCOPY PROCEDURE FOR THE TREATMENT OF STONES, THE FIBER BROKE WHILE INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A SECOND FIBER. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17762342 ↗
• MalfunctionApr 17, 2023Break; Break

  IT WAS REPORTED THAT DURING A PROCEDURE TO TREAT URETER AND BLADDER STONES, THE FIBER PHYSICALLY BROKE. IT WAS NOTED THAT NO SIGNIFICANT BEND DEFLECTION WAS REQUIRED TO REACH THE TREATMENT SITE. A SECOND FIBER WAS USED; HOWEVER, THIS FIBER TIP OVERHEATED AND BURNT AND NEEDED TO BE REPLACED BY A THIRD FIBER TO COMPLETE THE PROCEDURE. THERE WERE NO OPERATOR OR PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16756685 ↗
• MalfunctionMar 17, 2023Break; Break

  IT WAS REPORTED THAT THE LASER FIBER SNAPPED AND BROKE OUTSIDE THE PATIENT DURING THE PROCEDURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16567810 ↗
• InjuryFeb 4, 2020Fracture; Fracture

  A FOREIGN USER FACILITY REPORTED THAT AT THE END OF A URETERIC STONE FRAGMENTATION PROCEDURE IN WHICH A LUMENIS PULSE 100 LASER WAS BEING UTILIZED WITH A LUMENIS SLIMLINE EZ 365 FIBER, THE FIBER FRACTURED CAUSING A BURN TO A MEMBER OF THE NURSING STAFF. THE STAFF BURN WAS REPORTED TO HAVE "OCCURRED AT THE END OF THE PROCEDURE; WHEREAS THE LASER WAS NO LONGER NEEDED AFTER THAT SO THE PROCEDURE WAS NOT AFFECTED."

  Patient problems: Burn(s)

  MAUDE report 9664099 ↗