Dornier MedTech 270 Micron SU Thulio Slim Performance 3m FiberRecalls & reported problems
Dornier Medtech America, Inc. · 270 Micron SU Thulio Slim Performance 3m Fiber · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00810116023271), received between Oct 12, 2023 and Mar 4, 2026 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Break” (3 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.
Reports received per month
Most reported problems
Device problems
- Break3
- No Apparent Adverse Event2
Patient problems
- No Clinical Signs, Symptoms or Conditions5
- Insufficient Information1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 4, 2026Break
DMTA RECEIVED A REPORT THAT A FIBER BROKE PRIOR TO A PROCEDURE. THE FIBER WAS EXTERNAL TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24512374 ↗MalfunctionDec 30, 2025Break; Break
DMTA RECEIVED A REPORT THAT A FIBER BROKE DURING A PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23927437 ↗MalfunctionDec 30, 2025Break; Break
DMTA RECEIVED A REPORT THAT A PHYSICIAN OBSERVED A BREAK IN A THULIO FIBER AFTER IT WAS ATTACHED TO THE LASER UNIT. THEN DURING THE PROCEDURE AND USING A NEW FIBER, THE PHYSICIAN FIRED THE FIBER WITHOUT REALIZING IT WAS BROKEN AS WELL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23927436 ↗MalfunctionDec 29, 2025No Apparent Adverse Event; No Apparent Adverse Event
DMTA RECEIVED A CUSTOMER COMPLAINT THAT FIBERS WOULD CRACKLE AND DISCONNECT FROM THE LASER DURING PROCEDURES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23916741 ↗MalfunctionOct 18, 2024No Apparent Adverse Event; No Apparent Adverse Event
DMTA QUALITY WAS CONTACTED REGARDING A THULIO LASER FIBER WHICH WAS REPORTED TO HAVE FAILED STATING THE DEVICE, "BROKE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20480905 ↗MalfunctionOct 12, 2023
LASER FIBER IN USE DURING LASER LITHOTRIPSY OF KIDNEY STONE. WHEN FIBER WAS REMOVED FROM THE BLADDER IT WAS NOTED THAT THE TIP WAS FRAYED, AND A PORTION OF THE TIP WAS MISSING.
Patient problems: Insufficient Information
MAUDE report 17919195 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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