SlimLine™ SlimLine™ SIS 365Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 07290109145587), received between Sep 9, 2022 and Sep 29, 2026 — classified as 3 injuries, 22 malfunctions.

The most frequently reported specific device problem is “Break” (16 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 25 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Nonstandard Device; Overheating of Device

  It was reported that during a Transurethral Lithotripsy procedure, approximately 10 minutes after fragmentation, a sudden crackling noise was heard coming from the device. Fragmentation could no longer be performed, indicating that energy was not being transmitted, and black burn marks was noted on the fiber connector. The fiber was replaced and the case was completed without patient complications. Analysis of the returned device identified an internal connector fracture.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50927761 ↗
• MalfunctionFeb 24, 2026Material Integrity Problem

  IT WAS REPORTED THAT A SOUND WAS NOTICED DURING USE, AND THE FIBER WAS FOUND TO BE BURNT. THE DEBRIS SHIELD WAS ALSO OBSERVED TO BE DAMAGED. DUE TO THIS, THE PROCEDURE COULD NOT BE COMPLETED AND WAS DISCONTINUED. THERE WERE NO PATIENT COMPLICATIONS. THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER GENERAL ANESTHESIA. THIS COMPLAINT REFERS TO THE FIBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24431346 ↗
• MalfunctionNov 20, 2025Nonstandard Device; Power Problem; Nonstandard Device; Power Problem

  IT WAS REPORTED THAT, DURING A HOLMIUM LASER LITHOTRIPSY FOR BILATERAL URETERAL CALCULI AND IN THE PROCESS OF BREAKING THE STONES, THE FIBER MADE AN ABNORMAL NOISE AND STOPPED WORKING IMMEDIATELY. ANOTHER FIBER OF THE SAME LOT NUMBER WAS USED AND HAD THE SAME ISSUE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT FIBER. THERE WERE NO PATIENT COMPLICATIONS. ANALYSIS OF THE RETURNED DEVICE IDENTIFIED THAT THE FIBER WAS BROKEN INTO TWO PIECES. THIS COMPLAINT REFERS TO THE FIRST FIBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23611801 ↗
• MalfunctionNov 20, 2025Defective Device; Power Problem; Defective Device; Power Problem

  IT WAS REPORTED THAT, DURING A HOLMIUM LASER LITHOTRIPSY FOR BILATERAL URETERAL CALCULI AND IN THE PROCESS OF BREAKING THE STONES, THE FIBER MADE AN ABNORMAL NOISE AND STOPPED WORKING IMMEDIATELY. ANOTHER FIBER OF THE SAME LOT NUMBER WAS USED AND HAD THE SAME ISSUE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS. ANALYSIS OF THE RETURNED DEVICE IDENTIFIED THAT THE FIBER WAS BROKEN INTO TWO PIECES. THIS COMPLAINT REFERS TO THE SECOND FIBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23607219 ↗
• MalfunctionNov 17, 2025Break; Break

  IT WAS REPORTED THAT DURING PROCEDURE THE FIBER BODY WAS BROKEN. THE PROCEDURE WAS COMPLETED USING ANOTHER FIBER. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23569394 ↗
• MalfunctionJul 14, 2025Defective Device; Power Problem; Defective Device; Power Problem

  IT WAS REPORTED THAT THE FIBER STOPPED WORKING AND HAD NO OUTPUT WHEN ACTIVATING THE LASER DURING THE PERCUTANEOUS NEPHROLITHOTOMY PROCEDURE. A NOISE WAS HEARD FROM THE FIBER CONNECTOR. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WERE NO PATIENT COMPLICATIONS. ANALYSIS OF THE RETURNED FIBER IDENTIFIED AN INTERNAL CONNECTOR FRACTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22503295 ↗
• MalfunctionMay 6, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT DURING UNPACKING, A FOREIGN BODY DROPPED OUT FROM THE NEW FIBER WHEN IT WAS OPENED FROM THE PACKAGING. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE WITHOUT PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21971950 ↗
• InjuryApr 15, 2025Break; Break

  IT WAS REPORTED THAT DURING A LEFT DISTAL URETEROLITHIASIS PROCEDURE FOR KIDNEY STONE, WHEN THE FIBER WAS REMOVED FROM THE PATIENT, THE FIBER BURST AND BROKE, SUPERFICIALLY BURNING THE INSTRUMENT TECHNICIAN FINGER. THIS FIBER HAD 3 USES, A NEW FIBER WITH ZERO USES WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT COMPLICATION.

  Patient problems: Burn(s)

  MAUDE report 21843694 ↗
• InjuryApr 10, 2025Break; Break

  IT WAS REPORT THAT DURING THE PROCEDURE, THE FIBER GENERATED A SPARK THAT BURNED THE SPECIALIST, THEN IT BROKE THE PART WHERE THE FIBER EXITS THE SEMI RIGID URETEROSCOPE. THE PROCEDURE OUTCOME WAS UNKNOWN. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: Burn(s)

  MAUDE report 21811479 ↗
• MalfunctionApr 4, 2025Defective Device; Device Contaminated During Manufacture or Shipping; Adverse Event Without Identified Device or Use Problem; Defective Device; Device Contaminated During Manufacture or Shipping; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, DURING PREPARATION FOR RETROGRADE INTRARENAL SURGERY (RIRS) PROCEDURE, WHILE UNPACKING FIBER, A FOREIGN BODY DROPPED OUT FROM PACKING. THE DEVICE WAS REMOVED. THE FIBER WAS REPLACED, AND THE PROCEDURE WAS COMPLETED USING ANOTHER OF SAME MODEL WITH NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21775916 ↗
• MalfunctionFeb 12, 2025Break; Break

  IT WAS REPORTED THAT, DURING URETEROSCOPY/URETERORENOSCOPY (URS) PROCEDURE, TWO FIBERS WERE BROKEN AT THE BODY. THE FIBER WAS REPLACED, AND THE PROCEDURE WAS COMPLETED USING ANOTHER OF SAME MODEL WITH NO PATIENT COMPLICATIONS. THIS COMPLAINT IS FOR THE SECOND DEFECTIVE FIBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21361770 ↗
• MalfunctionFeb 12, 2025Break; Break

  IT WAS REPORTED THAT, DURING URETEROSCOPY/URETERORENOSCOPY (URS) PROCEDURE, TWO FIBERS WERE BROKEN AT THE BODY. THE FIBER WAS REPLACED, AND THE PROCEDURE WAS COMPLETED USING ANOTHER OF SAME MODEL WITH NO PATIENT COMPLICATIONS. THIS COMPLAINT IS FOR THE FIRST DEFECTIVE FIBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21361767 ↗
• MalfunctionSep 30, 2024Break; Break

  IT WAS REPORTED THAT DURING A TRANSURETHRAL LITHOTRIPSY, THE FIBER GOT BROKEN DURING ITS INITIAL USE, OUTSIDE OF THE BODY OF THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER FIBER WITHOUT PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20333415 ↗
• MalfunctionSep 24, 2024Break; Break

  IT WAS REPORTED THAT, DURING A PROCEDURE, THE FIBER WAS UNPACKED AND CONNECTED, AND WAS IDENTIFIED TO BE FRACTURED AT THE CONNECTOR. THE FIBER WAS REPLACED. PATIENT AND PROCEDURE OUTCOME ARE UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20290853 ↗
• MalfunctionAug 9, 2024Break; Break

  IT WAS REPORTED THAT DURING PROCEDURE WHEN THE LASER LIGHT WAS ACTIVATED, IT WOULD RUN DOWNWARDS. THE EVENT WAS DESCRIBED AS A POSSIBLE MICROFRACTURE. IT WAS CONFIRMED THAT THE FIBER WAS PHYSICALLY BROKEN. THIS WAS THE FIBER THIRD USED AND IT HAD BEEN PREVIOUSLY STERILIZED. THE PROCEDURE WAS COMPLETED USING A NEW FIBER. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19953870 ↗
• MalfunctionAug 9, 2024Break; Break

  IT WAS REPORTED THAT DURING PROCEDURE WHEN THE LASER LIGHT WAS ACTIVATED, IT WOULD RUN DOWNWARDS. THE PHYSICIAN DESCRIBED THE EVENT AS A POSSIBLE MICROFRACTURE, WHICH WAS LATER CONFIRMED. THE FIBER WAS PREVIOUSLY STERILIZED, AND IT WAS ITS NINTH USE. THE PROCEDURE WAS COMPLETED USING ANOTHER FIBER, THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19953533 ↗
• MalfunctionJul 30, 2024Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A TRANSURETHRAL LITHOTOMY PROCEDURE TO TREAT KIDNEY STONES, THE FIBER TIP BROKE OFF AND IT REMAINED INSIDE THE RENAL PELVIS OF THE PATIENT. IT WAS TRIED TO USED FORCEPS FOR FOREIGN OBJECTS IN ORDER TO REMOVE THE FIBER, BUT IT DID NOT WORK. THE CASE WAS FINISHED WITH THE FIBER PIECE REMAINING INSIDE THE PATIENT; HOWEVER, THE INTENDED TREATMENT WAS NOT COMPLETED. IT WAS INFORMED THAT ABOUT 2 CM OF THE FIBER JACKET HAD BEEN STRIPPED AND IT IS UNKNOWN HOW MANY TIMES THE REUSABLE FIBER WAS USED. ANOTHER SURGERY WILL BE PERFORMED AT A LATER DATE, AND THE FIBER IS BEING ASKED TO BE RETRIEVED FOR EXAMINATION. ADDITIONALLY, IT WAS INFORMED THAT THE BROKEN FIBER TIP WAS ABOUT 5 MM. THE RENAL STONE REMAINED INSIDE THE BODY OF THE PATIENT, AND IT WAS NOT COMPLETELY REMOVED, THEREFORE, THE PATIENT WAS SENT TO ANOTHER HOSPITAL. AS OF TODAY, THE PATIENT IS STABLE IN THE HOSPITAL AND THE PLAN IS TO PERFORM A TRANSURETHRAL LITHOTOMY PROCEDURE. THERE IS NO INFORMATION OF THE DATE FOR THE NEXT SURGERY.

  Patient problems: Foreign Body In Patient

  MAUDE report 19868710 ↗
• MalfunctionJul 10, 2024Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, THE TAIL END OF THE FIBER FRACTURED DURING PROCEDURE. THE FIBER WAS REPLACED, AND THE PROCEDURE WAS COMPLETED USING ANOTHER FIBER. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19711302 ↗
• MalfunctionJun 25, 2024Break; Break

  IT WAS REPORTED THAT DURING THE PROCEDURE WHILE THE LASER FIBER WAS IN USE, THE FIBER GAVE WAY ABRUPTLY IN THE USER HAND. THE PART OF THE FIBER CONNECTED TO THE LASER FELL TO THE GROUND AND THE OTHER END OF THE FIBER, WHICH WAS INSIDE THE PATIENT WAS REMOVED. NO LESIONS WERE FOUND ON EITHER THE PATIENT OR THE USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19611071 ↗
• MalfunctionJan 22, 2024Defective Device; Adverse Event Without Identified Device or Use Problem; Defective Device; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER FIRST USE, BLACK SPOTS WERE FOUND ON THE FIBER. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WERE NO PATIENT COMPLICATIONS. THE FIBER WAS RETURNED, AND ANALYSIS IDENTIFIED A FRACTURE WITHIN THE CONNECTOR; THEREFORE, REPORTABILITY CRITERIA IS MET BASED ON THIS FINDING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18554665 ↗
• MalfunctionAug 11, 2023Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING PROCEDURE THE FIBER BROKE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17516075 ↗
• MalfunctionJul 26, 2023Break; Break

  IT WAS REPORTED THAT THE FIBER BROKE IN 2 PIECES DESPITE NO TENSION. A NEW FIBER WAS USED BECAUSE THE FIRST ONE WAS NOT LONG ENOUGH TO CONTINUE THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING THE SECOND FIBER WITHOUT PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17401771 ↗
• MalfunctionJul 24, 2023Break; Break

  IT WAS REPORTED THAT THE FIBER BODY BROKE OFF ABOUT 1MM FROM THE FIBER CONNECTOR DURING PROCEDURE. THE PROCEDURE WAS COMPLETED USING ANOTHER FIBER WITH NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17378685 ↗
• InjuryMay 30, 2023Break; Break

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE FIBER BROKE IN HALF. THE BREAK OCCURRED AT THE LEVEL OF THE SURGEON'S RIGHT ARM, AND THE LASER ENERGY PENETRATED THE SLEEVE OF THE GOWN BURNING THE SURGEON'S RIGHT ARM. IT WAS NOTED THAT THE FIBER WAS BEING USED AT 12HZ AND 1.2J WHEN IT BROKE. THERE WERE NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: Burn(s)

  MAUDE report 17027366 ↗
• MalfunctionSep 9, 2022Contamination; Device Contaminated at the User Facility; Contamination; Device Contaminated at the User Facility

  IT WAS REPORTED THAT THERE WERE BLACK SPOTS AFTER USING THE REUSABLE SLIM LINE FOR THE 6TH TIME. THE DEBRIS SHIELD WAS ALSO BURNT AND WAS REPLACED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15396812 ↗