MAUDE Adverse Event Report: DORNIER MEDTECH AMERICA INC. DORNIER THULIO PERFORMANCE FIBER; THULIO LASER FIBER

Model Number	DORNIER THULIO PERFORMANCE FIBER
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that a thulio fiber broke external to a patient.The dhr review confirmed that the suspect fiber was manufactured without variances or deviations.Evaluation of the returned fiber confirmed that the fiber was broken into two pieces.Past complaints were reviewed, and no trend related to thulio fibers breaking was identified.The risk associated with a fiber break is classified as medium.The available evidence suggests the break may have been caused by incorrect user handling of the fiber.
Event or Problem Description
Dmta received a report that a fiber broke prior to a procedure.The fiber was external to the patient.

• Brand Name: DORNIER THULIO PERFORMANCE FIBER
• Common Device Name: THULIO LASER FIBER
• Manufacturer (Section D): DORNIER MEDTECH AMERICA INC.; 1155 roberts blvd; suite 100; kennesaw GA 30144
• Manufacturer (Section G): DORNIER MEDTECH AMERICA INC.; 1155 roberts blvd; suite 100; kennesaw GA 30144
• Manufacturer Contact: edward grammer ; 1155 roberts blvd; suite 100; kennesaw, GA 30144 ; 4072024117
• MDR Report Key: 24512374
• Report Number: 1037955-2026-00005
• Device Sequence Number: 13290634
• Product Code: GEX
• UDI-Device Identifier: 00810116023271
• UDI-Public: 00810116023271
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K152591
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 03/04/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: DORNIER THULIO PERFORMANCE FIBER
• Device Catalogue Number: K2016361
• Device Lot Number: F4125S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/06/2026
• Initial Report FDA Received Date: 03/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/21/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 29 YR
• Patient Sex: Female