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Dornier MedTech 200 Micron Ball Tip Single Use HERecalls & reported problems

Dornier Medtech America, Inc. · Dornier 200 GentleFlex High Energy Laser Fiber - Dornier Direct · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00810116020720), received between Mar 27, 2021 and Apr 2, 2021 — classified as 2 malfunctions.

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.

Most reported problems

Device problems

  • No Apparent Adverse Event2

Patient problems

  • No Clinical Signs, Symptoms or Conditions2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionApr 2, 2021No Apparent Adverse Event; No Apparent Adverse Event

    A NOTIFICATION WAS RECEIVED REGARDING A HOLMIUM FIBER UNIT WHICH WAS REPORTED TO HAVE BURNED DURING USE. NO PATIENT HARM OR IMPACT WAS REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11609280 ↗
  • MalfunctionMar 27, 2021No Apparent Adverse Event; No Apparent Adverse Event

    A NOTIFICATION WAS RECEIVED REGARDING A HOLMIUM FIBER UNIT WHICH WAS REPORTED TO HAVE BURNED DURING USE. NO PATIENT HARM OR IMPACT WAS REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11579017 ↗

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Sources and updates

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