SlimLine™ Slimline™ EZ SIS 365Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 07290109147031), received between Jul 31, 2023 and Aug 22, 2025 — classified as 2 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Break” (6 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.

• MalfunctionAug 22, 2025Defective Device; Device Displays Incorrect Message; Defective Device; Device Displays Incorrect Message

  IT WAS REPORTED THAT DURING A RETROGRADE INTRARENAL URETEROSCOPY SURGERY (RIRS), THE FIRST TWO FIBERS USED DID NOT WORK PROPERLY. THE ERROR CODE 66 WAS FOUND WITH ONE OF THE TWO DEFECTED FIBERS. THE PROCEDURE WAS COMPLETED WITH A THIRD FIBER WITHOUT PATIENT COMPLICATIONS. ANALYSIS OF THE RETURNED DEVICE IDENTIFIED A FIBER BODY FRACTURE. THIS COMPLAINT IS FOR THE SECOND DEFECTIVE FIBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22873978 ↗
• MalfunctionAug 22, 2025Defective Device; Defective Device

  IT WAS REPORTED THAT, DURING RETROGRADE INTRARENAL SURGERY (RIRS) PROCEDURE, THE FIRST TWO FIBERS USED DID NOT WORK PROPERLY. THE ERROR CODE 66 WAS FOUND WITH ONE OF THE TWO DEFECTED FIBERS. THE PROCEDURE WAS COMPLETED WITH A THIRD FIBER WITHOUT PATIENT COMPLICATIONS. ANALYSIS OF THE RETURNED DEVICE IDENTIFIED A FIBER TIP FRACTURE. THIS COMPLAINT IS FOR THE FIRST DEFECTIVE FIBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22873975 ↗
• MalfunctionNov 27, 2024Break; Break

  IT WAS REPORTED THAT DURING A TRANS URETERAL LITHOTRIPSY PROCEDURE, THE FIBER BROKE AND GOT DAMAGED ON THE INTERNAL DISTAL SIDE. 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 20800366 ↗
• MalfunctionJun 26, 2024Break; Break

  IT WAS REPORTED THAT, DURING THE PROCEDURE TO TREAT URETERIC STONES, THE FIBER BODY BROKE OFF IN CATHETER WHILE IT WAS INSIDE THE PATIENT, AFTER LASERING FOR ABOUT 5 TO 10 MINUTES. A SEMIRIGID SCOPE WAS BEING USED AT THE TIME. THE PHYSICIAN DOES NOT RECALL ANY KINKS OR BENDS IN THE FIBER. ALL FIBER FRAGMENTS WERE RETRIEVED FROM THE PATIENT USING BASKET RETRIEVAL. THE FIBER WAS REPLACED, AND THE PROCEDURE WAS COMPLETED USING THE SECOND FIBER. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19616040 ↗
• InjuryOct 13, 2023Break; Break

  IT WAS REPORTED THAT DURING A LASER LITHOTRIPSY PROCEDURE FOR RENAL SYSTEM STONES, THE FIBER BROKE IN THE SURGEON HAND DURING USE AND BURNT HIS FINGER. FIRST AID WAS APPLIED, AND THE PROCEDURE WAS COMPLETE WITH ANOTHER FIBER. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: Burn(s)

  MAUDE report 17932525 ↗
• InjuryOct 10, 2023Break; Break

  IT WAS REPORTED THAT DURING A PROCEDURE, THE FIBER BROKE IN THE SURGEON'S HAND DURING USE AND BURNT HIS FINGER, THE SURGEON WAS ATTENDED WITH FIRST AID. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE WITHOUT PATIENT COMPLICATIONS.

  Patient problems: Burn(s)

  MAUDE report 17909619 ↗
• MalfunctionAug 30, 2023Break; Break

  IT WAS REPORTED THAT DURING A URETER STONE PROCEDURE, THE FIBER BROKE INTO TWO PIECES. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17653509 ↗
• MalfunctionJul 31, 2023Break; Break

  IT WAS REPORTED THAT DURING AN URETEROSCOPY PROCEDURE FOR STONES IN URETER, AT THE FIRST TIME THE FIBER FIRED THE LASER, THE FIBER BROKE. THE PROCEDURE COULD BE COMPLETED USING ANOTHER FIBER. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17431487 ↗