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
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
- 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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