SlimLine™ SlimLine™ SIS 550Recalls & reported problems

Summary

The FDA's MAUDE database contains 231 adverse event reports that list this exact device (DI 07290109145600), received between Aug 30, 2022 and Sep 24, 2026 — classified as 22 injuries, 209 malfunctions.

The most frequently reported specific device problem is “Break” (124 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 231 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Break

  It was reported that the fiber was breaking during the procedure. The procedure was completed with another device. There were no patient complications.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50884309 ↗
• MalfunctionSep 22, 2026Material Integrity Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50862346 ↗
• MalfunctionSep 22, 2026Thermal Decomposition of Device; Nonstandard Device

  It was reported that during a removal of kidney stone procedure, when the fiber was connected and the laser activation began, the fiber tip burned out. The case was completed with a different device without patient complications. Analysis of the returned device identified that the fiber tip was broken.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50860733 ↗
• MalfunctionSep 22, 2026Nonstandard Device; Overheating of Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50860729 ↗
• MalfunctionSep 21, 2026Material Integrity Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50848626 ↗
• MalfunctionSep 21, 2026Nonstandard Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50848228 ↗
• MalfunctionSep 15, 2026Thermal Decomposition of Device; Nonstandard Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50777188 ↗
• MalfunctionSep 4, 2026Break; Thermal Decomposition of Device

  It was reported that during a Ureteroscopy with Laser Lithotripsy (URSL) procedure, it was found that during the third use, the fiber's distal tip burned and appeared slightly chipped or fractured. The procedure was completed with another of the same device without patient complications.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50602359 ↗
• MalfunctionAug 31, 2026Break

  It was reported that during preparation prior to a procedure, it was noticed that the fiber was broken near the connector. The procedure was completed by using another fiber, patient outcome was not reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50526949 ↗
• MalfunctionAug 10, 2026Break; Nonstandard Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50196767 ↗
• InjuryJul 31, 2026Break

  It was reported that the fiber had been in use and lasering for thirty to forty minutes and approximately 90+ joules when the fiber snapped. The fiber was inspected and seemed fine per the customer. However, when the fiber had snapped it had wrapped around and snagged on the resectoscope and the camera drape, light lead, or irrigating tubing. The snap in the fiber resulted in the consultant getting a small burn on their thumb. The wound was treated by washing and disinfecting it, applying a dressing, and then rescrubbing to complete the procedure. The patient or procedure outcome information was not provided.

  Patient problems: Burn(s)

  MAUDE report 50100164 ↗
• MalfunctionJun 22, 2026Nonstandard Device

  IT WAS REPORTED THAT DURING UNPACKING IT WAS NOTICED THAT THERE WERE BLACK SPOTS ON THE FIBER LENS. THE PROCEDURE WAS COMPLETED USING ANOTHER FIBER. THERE WERE NO PATIENT COMPLICATIONS. ANALYSIS OF THE RETUNED FIBER IDENTIFIED DISTORTED LIGHT WAS EXITING THE CONNECTOR FACE INDICATING AN INTERNAL CONNECTOR FRACTURE; THEREFORE, REPORTING CRITERIA IS MET BASED ON THIS FINDING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25588739 ↗
• MalfunctionJun 19, 2026Nonstandard Device

  IT WAS REPORTED THAT DURING A HOLMIUM LASER LITHOTRIPSY PROCEDURE FOR CALCULUS ON RIGHT URETER, THE FIBER DID NOT EMIT ENERGY. DUE TO THIS, THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WERE NO PATIENT COMPLICATIONS. THE DEVICE RETURNED AND IT WAS ANALYZED, DURING THIS INSPECTION IT WAS FOUND THAT THE FIBER CONNECTOR HAD NO LIGHT EXITING THE FACE, THIS IS INDICATIVE OF AN INTERNAL CONNECTOR FRACTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25567841 ↗
• MalfunctionJun 16, 2026Nonstandard Device

  IT WAS REPORTED THAT, DURING PROCEDURE, THE FIBER WAS DAMAGED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS. ANALYSIS OF THE RETURNED FIBER IDENTIFIED THAT THE FIBER CONNECTOR WAS FRACTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25523848 ↗
• MalfunctionJun 16, 2026Overheating of Device

  IT WAS REPORTED THAT DURING A PROCEDURE, THE FIBER GOT BURNT. THE PROCEDURE WAS COMPLETED WITH ANOTHER FIBER WITHOUT PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25520917 ↗
• MalfunctionJun 11, 2026Nonstandard Device

  IT WAS REPORTED THAT PRIOR A FLEXIBLE URETEROSCOPIC LITHOTRIPSY PROCEDURE, SOME BLACK SPOTS WERE FOUND ON FIBER DURING THE FIRST USE. DUE TO THIS, THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WERE NO PATIENT COMPLICATIONS. THE DEVICE RETURNED AND IT WAS ANALYZED, DURING THIS INSPECTION IT WAS FOUND THAT THE FIBER CONNECTOR HAD AN INTERNAL CONNECTOR FRACTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25479986 ↗
• MalfunctionJun 10, 2026Failure to Fire

  IT WAS REPORTED THAT, DURING PROCEDURE, THE AIMING BEAM WAS NOT VISIBLE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WERE NO PATIENT COMPLICATIONS. ANALYSIS OF THE RETURNED DEVICE IDENTIFIED A CONNECTOR FRACTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25465466 ↗
• MalfunctionJun 8, 2026Material Integrity Problem

  IT WAS REPORTED THAT THE FIBER WAS DAMAGED IN ITS FIRST USE AFTER OPENING THE PRODUCT. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25436527 ↗
• MalfunctionJun 8, 2026Nonstandard Device

  IT WAS REPORTED THAT THE FIBERS HAVE BEEN DAMAGING THE DEBRIS SHIELDS, AND ABNORMAL DEGRADATION OF THE DEBRIS SHIELDS HAS BEEN OBSERVED. NO FURTHER INFORMATION WAS PROVIDED. ANALYSIS OF THE RETURNED FIBER IDENTIFIED THAT THE CONNECTOR HAD DISTORTED LIGHT EXITING THE FACE INDICATING AN INTERNAL CONNECTOR FRACTURE. THIS REPORT REFERS TO SIXTH FIBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25426921 ↗
• MalfunctionJun 7, 2026Material Integrity Problem

  IT WAS REPORTED THAT DURING A HOLMIUM LASER ENUCLEATION OF THE PROSTATE PROCEDURE, THE DEBRIS SHIELD WAS CLEAN; HOWEVER, THE FIBER ITSELF WAS FOUND TO BE DAMAGED UPON ITS FIRST USE IMMEDIATELY AFTER THE PRODUCT WAS OPENED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE OF THE SAME TYPE WITHOUT ANY REPORTED PATIENT COMPLICATIONS. ANALYSIS OF THE RETURNED DEVICE IDENTIFIED AN INTERNAL CONNECTOR FRACTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25422645 ↗
• MalfunctionJun 3, 2026Nonstandard Device; Material Integrity Problem

  IT WAS REPORTED THAT, DURING PROCEDURE, THE FIBER EMITTED ABNORMAL SOUND WHEN FIRING AND BLACK DOTS WERE FOUND. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS. ANALYSIS OF THE RETURNED FIBER IDENTIFIED THERE WAS NO LIGHT EXITING THE CONNECTOR FACE INDICATING AN INTERNAL CONNECTOR FRACTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25383137 ↗
• MalfunctionJun 3, 2026Overheating of Device

  IT WAS REPORTED THAT, DURING PROCEDURE, THE FIBER BURNT DURING ITS SECOND USE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME MODEL. THERE WERE NO PATIENT COMPLICATIONS. ANALYSIS OF THE RETURNED FIBER IDENTIFIED THAT THE FIBER CONNECTOR WAS FRACTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25379753 ↗
• MalfunctionMay 29, 2026Nonstandard Device

  IT WAS REPORTED THAT, THERE IS A POSSIBILITY OF BLACK SPOTS INSIDE THE FIBER. THIS WAS ONLY THE SECOND TIME IT HAD BEEN USED, INCLUDING THIS CASE, AND THERE WAS NOTHING DURING THE PREVIOUS PROCEDURE OR DURING STERILIZATION THAT WOULD HAVE PLACED ANY LOAD ON IT; THEREFORE, AN INVESTIGATION HAS BEEN REQUESTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS. ANALYSIS OF THE RETURNED FIBER IDENTIFIED THERE WAS NO LIGHT EXITING THE CONNECTOR FACE INDICATING AN INTERNAL CONNECTOR FRACTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25334430 ↗
• MalfunctionMay 28, 2026Deformation Due to Compressive Stress

  IT WAS REPORTED THAT DURING PROCEDURE, WHEN THE NEW FIBER WAS UNPACKED TO USE THE LASER, THE FIBER WAS FOUND TO BE KINKED, SO THE USE WAS DISCONTINUED. THE PROCEDURE WAS COMPLETED USING ANOTHER FIBER. THERE WERE NO PATIENT COMPLICATIONS. ANALYSIS OF THE RETURNED FIBER IDENTIFIED THAT THE FIBER BODY WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25322636 ↗
• MalfunctionMay 26, 2026Failure to Fire

  IT WAS REPORTED THAT DURING HOLMIUM LASER ENUCLEATION OF THE PROSTATE (HOLEP) PROCEDURE, THE LASER BEAM WAS NOT COMING OUT OF THE FIBER. THE PROCEDURE WAS COMPLETED USING ANOTHER FIBER WITHOUT PATIENT COMPLICATIONS. THE FIBER WAS RETURNED FOR ANALYSIS, AND ANALYSIS OF THE RETURNED IDENTIFIED INTERNAL CONNECTOR FRACTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25292696 ↗