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Dornier MedTech 270 Micron Reusable (REF HOL270R)Recalls & reported problems

Dornier Medtech America, Inc. · Dornier SmartFlex 270 Reusable 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 00810116020447), received between Nov 12, 2020 and Dec 3, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (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.

Most reported problems

Device problems

  • Fracture2

Patient problems

  • No Clinical Signs, Symptoms or Conditions2
  • No Consequences Or Impact To Patient2

Recent adverse event reports

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

  • MalfunctionDec 3, 2020Fracture; Fracture

    COMPLAINT INFORMATION WAS RECEIVED FOR A HOLMIUM FIBER WHICH WAS IDENTIFIED BROKEN OUT OF THE BOX PRIOR TO USAGE. NO PATIENT IMPACT OCCURRED DUE TO THIS PRODUCT COMPLAINT.

    Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

    MAUDE report 10937555 ↗
  • MalfunctionNov 12, 2020Fracture; Fracture

    COMPLAINT INFORMATION WAS RECEIVED FOR 2 HOLMIUM FIBERS, WHICH WERE IDENTIFIED BROKEN OUT OF THE BOX PRIOR TO USAGE. NO PATIENT IMPACT OCCURRED DUE TO THIS PRODUCT COMPLAINT.

    Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

    MAUDE report 10832215 ↗

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Sources and updates

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