Dornier MedTech 270 Micron Single Use (REF HOL270S)Recalls & reported problems
Dornier Medtech America, Inc. · Dornier SingleFlex 270 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 00810116020355), received between Sep 8, 2022 and May 14, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (1 report).
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
- Break1
- Fracture1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- Superficial (First Degree) Burn1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 14, 2026Break
DMTA RECEIVED A MEDWATCH FORM STATING THAT THE TIP OF A FIBER HAD BROKEN OFF INSIDE A PATIENT. THE BROKEN PIECE WAS EXTRACTED AND THERE WAS NO HARM TO THE PATIENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25175805 ↗MalfunctionSep 8, 2022Fracture; Fracture
A LASER FIBER WAS REPORTED TO HAVE BROKEN DURING USAGE, CAUSING A SUPERFICIAL BURN TO THE DOCTOR'S FINGER. NO FOLLOW UP OR TREATEMENT WAS DETERMINED TO BE MANDATORY DUE TO THE SUPERFICIAL BURN. NO FURTHER IMPACT WAS REPORTED TO DMTA AS A RESULT OF THE COMPLAINT AS REPORTED.
Patient problems: Superficial (First Degree) Burn
MAUDE report 15384341 ↗
Other Powered Laser Surgical Instrument devices
- Moxy 0010-2400Boston Scientific Corporation · Powered Laser Surgical Instrument4,572 reports
- SOLTIVE TFL-PLSGyrus ACMI, LLC · Powered laser surgical instrument6 recalls450 reports
- Flexiva TracTip M0068403960Boston Scientific Corporation · Powered laser surgical instrument562 reports
- Moses™ AC-10030100Lumenis Ltd. · Powered Laser Surgical Instrument532 reports
- Flexiva M0068403910Boston Scientific Corporation · Powered laser surgical instrument376 reports
- Visualase 9735542Medtronic Navigation, Inc. · Powered laser surgical instrument1 recall2 deaths311 reports
- SOLTIVE TFL-SLSGyrus ACMI, LLC · Powered laser surgical instrument6 recalls33 reports
- NeuroBlate® System 20980Monteris Medical Inc · Powered laser surgical instrument7 deaths296 reports
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.
How reports and recalls are matched · Editorial policy · Report an error on this page