Dornier MedTech 270 micron Holmium Laser Fiber Cable, Single Use, RFIDRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 04049958003097), received between Oct 25, 2019 and Sep 20, 2024 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Fracture” (3 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 20, 2024No Apparent Adverse Event; No Apparent Adverse Event

  DMTA QUALITY WAS CONTACTED REGARDING A HOLMIUM LASER FIBER WHICH WAS REPORTED TO HAVE BROKEN, "A URS TREATMENT HAS BEEN CONDUCTED IN WHICH A LASER FIBER WAS BROKEN".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20268353 ↗
• MalfunctionMay 14, 2021No Apparent Adverse Event; No Apparent Adverse Event

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11827088 ↗
• MalfunctionMar 23, 2021Fracture; No Apparent Adverse Event; Fracture; No Apparent Adverse Event

  A NOTIFICATION WAS RECEIVED REGARDING A HOLMIUM FIBER WHICH WAS REPORTED TO HAVE BURNED. NO PATIENT HARM WAS REPORTED. THIS COMPLAINT WAS INITIALLY REPORTED TO FDA UNDER 1037955-2020-00038 ON (B)(6) 2020.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11548816 ↗
• MalfunctionMar 17, 2021No Apparent Adverse Event; No Apparent Adverse Event

  THE NOTIFICATION WAS RECEIVED REGARDING A HOLMIUM FIBER WHICH WAS REPORTED TO HAVE BURNED. NO PATIENT HARM WAS REPORTED. THIS COMPLAINT WAS INITIALLY REPORTED TO FDA UNDER 1037955-2020-00025 ON (B)(6) 2020.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11502078 ↗
• MalfunctionMar 12, 2021Fracture; No Apparent Adverse Event; Fracture; No Apparent Adverse Event

  COMPLAINANT REPORTED TWO LASER FIBERS WERE OBSERVED TO BE BROKEN. ONE REPORTEDLY "SEPARATED" AND THE OTHER WAS OBSERVED TO "SNAP". BOTH INSTANCES OCCURED DURING USE. THIS COMPLAINT WAS INITIALLY REPORTED TO FDA UNDER 1037955-2020-00010 ON 03/27/2020.

  Patient problems: Burn(s)

  MAUDE report 11472798 ↗
• MalfunctionMar 5, 2021Connection Problem; No Apparent Adverse Event; Connection Problem; No Apparent Adverse Event

  COMPLAINT DETAILS PROVIDED IN THE INITIAL NOTIFICATION STATED, "FIBER BURNT AT CONNECTOR END. THIS WAS OBSERVED BY UT NURSE AFTER SURGERY." THIS COMPLAINT WAS INITIALLY REPORTED TO FDA UNDER 1037955-2019-00052 ON 10/15/2019

  Patient problems: Insufficient Information

  MAUDE report 11419878 ↗
• MalfunctionOct 8, 2020No Apparent Adverse Event; No Apparent Adverse Event

  A NOTIFICATION WAS RECEIVED REGARDING A HOLMIUM FIBER WHICH WAS REPORTED TO HAVE BURNED. NO PATIENT HARM WAS REPORTED.

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

  MAUDE report 10650776 ↗
• MalfunctionSep 2, 2020No Apparent Adverse Event; No Apparent Adverse Event

  A NOTIFICATION WAS RECEIVED REGARDING A HOLMIUM FIBER WHICH WAS REPORTED TO HAVE BURNED. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10483847 ↗
• MalfunctionApr 23, 2020Fracture; Fracture

  COMPLAINANT REPORTED TWO LASER FIBERS WERE OBSERVED TO BE BROKEN. ONE REPORTEDLY "SEPARATED" AND THE OTHER WAS OBSERVED TO "SNAP". BOTH INSTANCES OCCURRED DURING USE.

  Patient problems: Burn(s)

  MAUDE report 9992800 ↗
• MalfunctionOct 25, 2019Connection Problem; No Apparent Adverse Event; Connection Problem; No Apparent Adverse Event

  COMPLAINT DETAILS PROVIDED IN THE INITIAL NOTIFICATION STATED, "FIBER BURNT AT CONNECTOR END. THIS WAS OBSERVED BY UT NURSE AFTER SURGERY."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9238314 ↗