SlimLine™ SlimLine™ SIS 200Recalls & reported problems

Summary

The FDA's MAUDE database contains 225 adverse event reports that list this exact device (DI 07290109145556), received between Aug 23, 2022 and Sep 29, 2026 — classified as 2 injuries, 223 malfunctions.

The most frequently reported specific device problem is “Break” (97 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 225 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Material Integrity Problem

  After unpacked, during the inspection, it was found that the fiber was not transparent and damaged. The case was completed with another of same device. No patient complications. Analysis of the returned device identified an internal connector fracture.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50927640 ↗
• MalfunctionSep 28, 2026Thermal Decomposition of Device; Nonstandard Device

  It was reported that during a Retrograde Intrarenal Surgery (RIRS) procedure, this fiber was initially used with power settings of 1 Joule and 10 Hz. During the procedure, the physician requested an increase in frequency to 15 Hz while maintaining the same energy level. Immediately following the frequency increase, an audible sound was noted, and the laser fiber tip was found to be burnt. The blast shield was also observed to be damaged. The fiber had no physical break. The procedure was stopped, the fiber was withdrawn, and another machine and fiber were used to complete the procedure. No patient complications were reported. Analysis of the returned device identified a connector fractured.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50918057 ↗
• MalfunctionSep 25, 2026Break

  It was reported that during a stone fragmentation procedure to treat calculus in the kidney, the fiber tip fractured inside the patient. No fiber fragments fell inside the patient. The procedure was completed with a fiber replacement. The patient's condition following procedure was stable; there were no patient complications. There were no injuries to the operator of the fiber.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50896618 ↗
• MalfunctionSep 18, 2026Material Integrity Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50828987 ↗
• MalfunctionSep 17, 2026Material Integrity Problem

  It was reported that during procedure, the fiber was connected; however, the fiber was damaged, so the laser could not be used. The case was completed with a different device without patient complications. Analysis of the returned device identified a broken tip.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50808333 ↗
• MalfunctionSep 17, 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 an internal connector fracture.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50797106 ↗
• MalfunctionSep 11, 2026Break; Separation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50741475 ↗
• MalfunctionSep 8, 2026Break

  It was reported that during a holmium laser therapy procedure, during the first use, the fiber broke as soon as the console was activated. The procedure was completed with another fiber without patient complications.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50674131 ↗
• MalfunctionAug 3, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50122262 ↗
• MalfunctionJul 30, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50090526 ↗
• MalfunctionJun 23, 2026Nonstandard Device; Connection Problem

  IT WAS REPORTED THAT THE FIBER WAS NOT RECOGNIZED BY THE CONSOLE. THERE WERE NO PROCEDURE AND PATIENT OUTCOME REPORTED. ANALYSIS OF THE RETURNED DEVICE IDENTIFIED A FIBER BODY BROKEN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25602317 ↗
• MalfunctionJun 23, 2026Power Problem

  IT WAS REPORTED THAT DURING A LITHOTRIPSY PROCEDURE, THE FIBER COULD NOT BE USED AFTER IT SUDDENLY MADE AN ABNORMAL NOISE. THE CASE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THE PATIENTS CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE. ANALYSIS OF THE RETURNED DEVICE IDENTIFIED AN INTERNAL FRACTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25589476 ↗
• MalfunctionJun 22, 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 FIBER TIP WAS BROKEN. THIS REPORT REFERS TO FIFTH FIBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25588147 ↗
• MalfunctionJun 17, 2026Nonstandard Device; Communication or Transmission Problem

  IT WAS REPORTED THAT DURING THE PROCEDURE WHEN THE FIBER WAS CONNECTED FOR THE THIRD STERILIZATION CYCLE, THE ERROR 54 (FIBER ERROR) OCCURRED. IT WAS REPLACED WITH ANOTHER REUSABLE FIBER, BUT THE SAME ERROR RECURRED. AFTER REPEATEDLY DISCONNECTING AND RECONNECTING THE CONNECTION POINT, THE FIBER BECAME FUNCTIONAL. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WAS NO PATIENT COMPLICATION. AFTER THAT, THE FIBER WAS RETURNED FOR ANALYSIS AND THE MICROSCOPE INSPECTION FOUND THERE WAS NO LIGHT EXITING THE CONNECTOR FACE WHICH IS INDICATIVE OF AN INTERNAL CONNECTOR FRACTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25536410 ↗
• MalfunctionJun 11, 2026Nonstandard Device

  IT WAS REPORTED THAT DURING FLEXIBLE URETEROSCOPIC LITHOTRIPSY PREPARATION, THERE WERE FOUND BLACK SPOTS. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WAS NO PATIENT COMPLICATION. AFTER THAT, THE FIBER WAS RETURNED FOR ANALYSIS AND THE MICROSCOPE INSPECTION FOUND THAT NO LIGHT WAS EXITING THE CONNECTOR FACE INDICATING AN INTERNAL CONNECTOR FRACTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25480017 ↗
• MalfunctionJun 11, 2026Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT, THE FIBER WAS FOUND DAMAGED UPON OPENING THE PACKAGE. THERE WERE NO PATIENT COMPLICATIONS. ANALYSIS OF THE RETURNED DEVICE IDENTIFIED A CONNECTOR FRACTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25474193 ↗
• MalfunctionJun 8, 2026Device Handling Problem

  IT WAS REPORTED THAT DURING UNPACKING THERE WAS FOUND THE END FACE OF THE FIBER WAS DAMAGED. THIS EVENT OCCURRED OUTSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WAS NO PATIENT COMPLICATION. AFTER THAT, THE FIBER WAS RETURNED FOR ANALYSIS AND THE INVESTIGATION DETERMINED THAT THE FIBER HAS AN INTERNAL CONNECTION FRACTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25436587 ↗
• 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 FIBER TIP WAS BROKEN. THIS REPORT REFERS TO FOURTH FIBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25426922 ↗
• MalfunctionJun 3, 2026Nonstandard Device

  IT WAS REPORTED THAT BLACK SPOTS APPEARED ON THE FIBER AFTER A SINGLE USE. THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS STABLE. THE ISSUE OCCURRED OUTSIDE THE PATIENT, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER FIBER. ANALYSIS OF THE RETURNED DEVICE INDICATED A FIBER CONNECTOR FRACTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25383142 ↗
• MalfunctionMay 28, 2026Break

  IT WAS REPORTED THAT DURING A RETROGRADE INTRARENAL SURGERY (RIRS) AFTER 10 TO 15 SECONDS OF USE, THE FIBER BODY GOT BROKEN FROM THE CONNECTING END WHILE DOING THE PROCEDURE. NO FIBER FRAGMENTS FALL INSIDE THE PATIENT. ANOTHER FIBER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT COMPLICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25319680 ↗
• MalfunctionMay 25, 2026Nonstandard Device

  IT WAS REPORTED THAT DURING A URINARY LITHOTRIPSY PROCEDURE TO TREATED URINARY STONES, BLACK SPOTS APPEARED AFTER THE FIRST FEW USES. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WAS NO PATIENT COMPLICATION. AFTER THAT, THE FIBER WAS RETURNED FOR ANALYSIS AND THE VISUAL INSPECTION FOUND THAT THE FIBER HAD A BODY BREAK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25273134 ↗
• MalfunctionMay 22, 2026Nonstandard Device

  IT WAS REPORTED THAT DURING A PROCEDURE, THE LASER BEAM DID NOT COME OUT. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE WITHOUT PATIENT COMPLICATIONS. ANALYSIS OF THE RETURNED FIBER IDENTIFIED AN INTERNAL CONNECTOR FRACTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25260072 ↗
• MalfunctionMay 20, 2026Nonstandard Device

  IT WAS REPORTED THAT BLACK SPOTS WERE FOUND ON THE FIBER. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS. ANALYSIS OF THE RETURNED DEVICE IDENTIFIED AN INTERNAL CONNECTOR FRACTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25234101 ↗
• MalfunctionMay 20, 2026Failure to Fire

  IT WAS REPORTED THAT THE AIMING BEAM WAS NOT COMING OUT. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WERE NO PATIENT COMPLICATIONS. ANALYSIS OF THE RETURNED FIBER IDENTIFIED THAT THERE WAS DISTORTED LIGHT EXITING THE CONNECTOR, INDICATING AN INTERNAL FRACTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25233438 ↗
• MalfunctionMay 19, 2026Failure to Fire

  IT WAS REPORTED THAT PRIOR TO A FLEXIBLE URETEROSCOPIC LITHOTRIPSY PROCEDURE FOR KIDNEY STONE, WHEN THE FIBER WAS UNPACKED FOR THE FIRST USE, IT HAD NO AIMING BEAM, THE FIBER COULD NOT OUTPUT ENERGY NORMALLY WHEN STEPPING ON THE LASER PEDAL, AND THE SPARE FIBER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT COMPLICATION. AFTER THAT, THE DEVICE WAS RETURNED FOR ANALYSIS AND THE INVESTIGATION DETERMINED THAT THE OBSERVED CONDITION OF NO LIGHT EXITING THE CONNECTOR CAN BE A RESULT OF AN INTERNAL CONNECTOR FRACTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25219621 ↗