Dornier MedTech 270 micron Holmium Laser Fiber Cable, Reusable, RFID (slim)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 04049958003165), received between Jul 20, 2023 and May 20, 2026 — classified as 9 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.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 20, 2026Break

  IT WAS REPORTED TO DMTA THAT DURING A PROCEDURE, A FIBER BROKE AT THE PROXIMAL END. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25231239 ↗
• MalfunctionApr 29, 2026Break

  DMTA RECEIVED A CUSTOMER COMPLAINT THAT THE HEAD OF THE FIBER DETACHED FROM THE REST OF THE FIBER. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25028184 ↗
• MalfunctionApr 16, 2026No Apparent Adverse Event

  DMTA RECEIVED A COMPLAINT STATING THAT A FIBER SHOWED SIGNS OF BURNING AND SPLITTING AT THE BLUE TIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24895548 ↗
• MalfunctionAug 25, 2025No Apparent Adverse Event; No Apparent Adverse Event

  DMTA RECEIVED A REPORT STATING THAT DURING A PROCEDURE, A CRACKLING SOUND WAS HEARD FROM THE FIBER AT ITS CONNECTION TO THE LASER. IMMEDIATELY AFTERWARD, THE PILOT LIGHT WENT OUT AND THE TREATMENT WAS HAULTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22890669 ↗
• MalfunctionJan 7, 2025No Apparent Adverse Event; No Apparent Adverse Event

  ON 9 DECEMBER 2024 DMTA QUALITY WAS CONTACTED REGARDING A HOLMIUM LASER FIBER WHICH WAS REPORTED TO HAVE BROKEN. NO PATIENT IMPACT WAS REPORTED AS A RESULT OF THE COMPLAINT EXPERIENCE. THE CUSTOMER STATED REGARDING THE COMPLAINT, "H35 MACHINE COULDN'T DETECT FIBER WHEN CONNECTED AND FIBER SUDDENLY BROKE ON ITS OWN INTRAOPERATIVELY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21097783 ↗
• MalfunctionJan 3, 2025No Apparent Adverse Event; No Apparent Adverse Event

  ON (B)(6) 2024 DMTA QUALITY WAS CONTACTED REGARDING A HOLMIUM LASER FIBER WHICH WAS REPORTED TO HAVE BROKEN. NO PATIENT IMPACT WAS REPORTED AS A RESULT OF THE COMPLAINT EXPERIENCE. THE CUSTOMER STATED REGARDING THE COMPLAINT, "AFTER CLEANING THE FIBER ONCE, THE FIBER WAS BENT.".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21069431 ↗
• MalfunctionDec 2, 2024No Apparent Adverse Event; No Apparent Adverse Event

  ON 30 OCTOBER 2024 DMTA QUALITY WAS CONTACTED REGARDING A HOLMIUM LASER FIBER WHICH WAS REPORTED TO HAVE BROKEN. NO PATIENT IMPACT WAS REPORTED AS A RESULT OF THE REPORTED FIBER FAILURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20825232 ↗
• MalfunctionJul 19, 2024No Apparent Adverse Event; No Apparent Adverse Event

  A HOLMIUM FIBER WAS REPORTED TO HAVE A DEFECT WITH, "LOOSE INTERNAL PARTS".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19783870 ↗
• MalfunctionJul 20, 2023No Apparent Adverse Event; No Apparent Adverse Event

  HOLMIUM LASER FIBER BURN AT THE CONNECTOR REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17367886 ↗