SlimLineRecalls & reported problems across all models
Lumenis Ltd. · 8 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 605
- Deaths reported
- 0
- Injuries reported
- 52
- Recalls
- 0
We found 8 models of SlimLine by Lumenis Ltd. in the FDA's device registry (GUDID). Together they are named in 605 adverse event reports in the FDA's MAUDE database, received between Aug 23, 2022 and Sep 29, 2026 — classified as 52 injuries, 553 malfunctions.
The most frequently reported specific device problem is “Break” (337 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported SlimLine problems
Device problems
- Break337
- Adverse Event Without Identified Device or Use Problem119
- Defective Device113
- Nonstandard Device68
- Material Integrity Problem29
- Overheating of Device18
- Use of Device Problem18
- Connection Problem17
Patient problems
- No Clinical Signs, Symptoms or Conditions551
- Burn(s)46
- Insufficient Information6
- Electric Shock3
- Superficial (First Degree) Burn3
- Foreign Body In Patient2
- Full thickness (Third Degree) Burn2
- Hematuria2
SlimLine models
8 models, most reported first. Each model has its own page with its reports, recalls and device details.
- SlimLine™ SlimLine™ SIS 550Powered Laser Surgical Instrument231 reports
- SlimLine™ SlimLine™ SIS 200Powered Laser Surgical Instrument225 reports
- SlimLine™ SlimLine™ SIS EZ 550Powered Laser Surgical Instrument75 reports
- SlimLine™ Slimline™ EZ SIS 200Powered Laser Surgical Instrument39 reports
- SlimLine™ SlimLine™ SIS 365Powered Laser Surgical Instrument25 reports
- SlimLine™ Slimline™ EZ SIS 365Powered Laser Surgical Instrument8 reports
- SlimLine™ SlimLine™ SIS 200 LPPowered Laser Surgical Instrument1 report
- SlimLine™ SlimLine™ SIS 1000Powered Laser Surgical Instrument1 report
Recent SlimLine adverse event reports
The 15 most recent reports across all models, 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 ↗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, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50919948 ↗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 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, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50848668 ↗MalfunctionSep 21, 2026Material Integrity Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50848628 ↗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 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 ↗
Other Lumenis Ltd. products
All Lumenis Ltd. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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