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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

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 1 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 3 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 1 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520263
Last 36 months. The most recent month may be incomplete.

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

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