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

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 04049958003158), received between Oct 22, 2019 and Dec 12, 2025 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Fracture” (4 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 12, 2025Break; Break

  DMTA RECEIVED A REPORT THAT A PHYSICIAN OBSERVED A BREAK IN THE HOLMIUM FIBER UPON REMOVING IT FROM THE PACKAGING, PRIOR TO USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23794561 ↗
• MalfunctionSep 10, 2024No Apparent Adverse Event; No Apparent Adverse Event

  DORNIER RECEIVED COMPLAINT INFORMATION REGARDING A LASER FIBER WHICH HAD REPORTEDLY BURNED. THE CUSTOMER STATED, "WHEN PLACED IN THE LASER, IT SMELLED LIKE BURNING".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20186101 ↗
• MalfunctionApr 23, 2024No Apparent Adverse Event; No Apparent Adverse Event

  HOLMIUM FIBER REPORTEDLY DEFECTIVE AND OBSERVED WITH THE "TOP OF THE SMA PIN CHARRED", POSSIBLY INDICATING A FIBER BURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19166430 ↗
• MalfunctionSep 18, 2023No Apparent Adverse Event; No Apparent Adverse Event

  A NOTIFICATION WAS RECEIVED REGARDING A HOLMIUM FIBER UNIT WHICH WAS REPORTED TO HAVE BROKEN DURING USAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17764021 ↗
• MalfunctionSep 12, 2023No Apparent Adverse Event; No Apparent Adverse Event

  HOLMIUM FIBER REPORTEDLY OVERHEATED/BURNED DURING USAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17732680 ↗
• MalfunctionAug 23, 2023No Apparent Adverse Event; No Apparent Adverse Event

  TWO HOLMIUM LASER FIBERS REPORTEDLY BURNED DURING USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17607281 ↗
• 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. ADDITIONAL COMPLAINT EXPERIENCES WERE REPORTED BY THE SAME CUSTOMER, LASER DEVICES NOT RECOGNIZING FIBERS, FIBERS NOT TRANSMITTING POWER PROPERLY, LOOSE CONNECTORS, FIBERS NOT WORKING. A TOTAL OF 7 UNITS WERE REPORTED FOR THREE SEPARATE PRODUCTION LOTS OF FIBERS UNDER TWO DIFFERENT PRODUCT ID'S. K2013151, LOT F0120R - 3 UNITS. K2013152 LOT B1018R - 3 UNITS. K2013151 LOT F0320R - 1 UNIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11609281 ↗
• MalfunctionMar 23, 2021Fracture; Fracture

  COMPLAINT INFORMATION WAS RECEIVED FOR A HOLIUM FIBER WHICH WAS IDENTIFIED TO HAVE BROKE. NO REPORTS OF INJURY OR PATIENT COMPLICATION WERE REPORTED TO DORNIER MEDTECH AMERICA DUE TO PRODUCT COMPLAINT. THIS COMPLAINT WAS INITIALLY REPORTED TO FDA UNDER 1037955-2020-00040 ON 09/14/2020.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11549586 ↗
• MalfunctionMar 22, 2021Fracture; Fracture

  COMPLAINT INFORMATION WAS RECEIVED FOR A HOLMIUM FIBER WHICH WAS IDENTIFIED TO HAVE BROKE INSIDE THE PATIENT DURING OPERATION. NO REPORTS OF INJURY OR PATIENT COMPLICATION WERE REPORTED TO DORNIER MEDTECH AMERICA DUE TO THIS PRODUCT COMPLAINT. THIS COMPLAINT WAS INITIALLY REPORTED TO FDA UNDER 1037955-2020-00036 ON (B)(6) 2020.

  Patient problems: Insufficient Information

  MAUDE report 11541910 ↗
• MalfunctionMar 15, 2021Connection Problem; No Apparent Adverse Event; Connection Problem; No Apparent Adverse Event

  A NOTIFICATION WAS RECEIVED REGARDING HOLMIUM FIBERS REPORTED TO HAVE BURNED. THE COMPLAINT REPORTED "4 THERAPEUTIC OPTIVAL FIBERS WERE BURNED, BATCH F5019R". NO PATIENT HARM WAS REPORTED. THIS COMPLAINT WAS INITIALLY REPORTED TO FDA UNDER 1037955-2020-00019 ON (B)(6) 2020.

  Patient problems: Burn(s)

  MAUDE report 11483390 ↗
• MalfunctionOct 14, 2020Fracture; Fracture

  COMPLAINT INFORMATION WAS RECEIVED FOR A HOLMIUM FIBER WHICH WAS IDENTIFIED TO HAVE BROKE. NO REPORTS OF INJURY OR PATIENT COMPLICATION WERE REPORTED TO DORNIER MEDTECH AMERICA DUE TO THIS PRODUCT COMPLAINT.

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

  MAUDE report 10680722 ↗
• MalfunctionOct 8, 2020No Apparent Adverse Event; No Apparent Adverse Event

  A NOTIFICATION WAS RECEIVED REGARDING HOLMIUM FIBER UNITS (5 UNITS), WHICH WERE REPORTED TO HAVE BURNED DURING USE WITH 2 CUSTOMER LASERS. NO PATIENT HARM WAS REPORTED.

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

  MAUDE report 10651859 ↗
• MalfunctionOct 1, 2020Fracture; Fracture

  COMPLAINT INFORMATION WAS RECEIVED FOR A HOLMIUM FIBER WHICH WAS IDENTIFIED TO HAVE BROKE INSIDE THE PATIENT DURING OPERATION. NO REPORTS OF INJURY OR PATIENT COMPLICATION WERE REPORTED TO DORNIER MEDTECH AMERICA DUE TO THIS PRODUCT COMPLAINT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10616136 ↗
• MalfunctionJul 8, 2020Connection Problem; No Apparent Adverse Event; Connection Problem; No Apparent Adverse Event

  A NOTIFICATION WAS RECEIVED REGARDING HOLMIUM FIBERS REPORTED TO HAVE BURNED. THE COMPLAINANT REPORTED, "4 THERAPEUTIC OPTICAL FIBES WERE BURNED, BATCH F5019R". NO PATIENT HARM WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10246226 ↗
• MalfunctionOct 22, 2019No Apparent Adverse Event; No Apparent Adverse Event

  COMPLAINT DETAILS PROVIDED IN THE INITIAL NOTIFICATION STATED, "WE RECEIVED A CUSTOMER COMPLAINT ABOUT BURNING OF THE NEW 270 MICROMETER REUSABLE FIBERS. THEY HAVE DAMAGED 3 UNUSED FIBERS".

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9220729 ↗