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Dornier MedTech 270 Micron Single Use HERecalls & reported problems

Dornier Medtech America, Inc. · Dornier SingleFlex 270 High Energy Laser Fiber - Dornier Direct · 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 00810116020744), received between Mar 25, 2021 and Jun 17, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Break” (2 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: 1 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 1 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 1 reportsJun 2026: 2 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520262
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • No Apparent Adverse Event4
  • Break2
  • Fracture1

Patient problems

  • No Clinical Signs, Symptoms or Conditions5
  • Superficial (First Degree) Burn1

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJun 17, 2026No Apparent Adverse Event

    IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, A DEFECT WAS IDENTIFIED IN A NEW LASER FIBER, CHARACTERIZED BY CHARRING AT THE BASE OF THE CONNECTOR. THIS REPORT ORIGINATED FROM ANVISA, AND MUCH OF THE INFORMATION WAS KEPT CONFIDENTIAL, LIMITING THE PRECISION OF THIS INVESTIGATION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25535813 ↗
  • MalfunctionJun 15, 2026Break

    IT WAS REPORTED THAT A FIBER BROKE INSIDE OF A PATIENT DURING A PROCEDURE. THERE WAS NO PATIENT HARM REPORTED IN RELATION TO THIS COMPLAINT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25505358 ↗
  • MalfunctionMay 1, 2026No Apparent Adverse Event

    DMTA RECEIVED A COMPLAINT STATING THAT A FIBER THROUGH THE STRESS RELIEF BOOT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25059909 ↗
  • MalfunctionJun 9, 2025Break

    LASER FIBER BROKE AND BURNED THE RESIDENT'S HAND.

    Patient problems: Superficial (First Degree) Burn

    MAUDE report 22169254 ↗
  • MalfunctionMar 14, 2024Fracture; No Apparent Adverse Event; Fracture; No Apparent Adverse Event

    A NOTIFICATION WAS RECEIVED REGARDING A HOLMIUM FIBER UNIT WHICH WAS REPORTED TO HAVE BROKEN DURING USAGE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18904636 ↗
  • MalfunctionMar 25, 2021No Apparent Adverse Event; No Apparent Adverse Event

    A NOTIFICATION WAS RECEIVED REGARDING HOLMIUM FIBER UNITS (2 UNITS) WHICH WERE REPORTED TO HAVE BURNED DURING USE. NO PATIENT HARM OR IMPACT WAS REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11572806 ↗

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Sources and updates

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