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	12/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Dmta received a report that a fiber broke during a procedure.
Additional Manufacturer Narrative
This investigation was conducted in response to a customer complaint stating that the tip of the fiber broke during a procedure.A device history record review was conducted and confirmed that there were no deviations or variances in the manufacturing process and the products met all dmta specifications prior to release.Past complaints were reviewed and at this time, there is no trend identified.The suspect fiber was disposed of and not available for evaluation.At this time, the root cause cannot be determined, it may have been caused by multiple factors including incorrect user handling.There were no defects identified in the manufacturing process related to this complaint.A fiber break is identified as a medium-level risk.There was no patient impact reported as a result of this malfunction.At this time, no further actions by dmta are determined to be necessary.

• 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: 23927437
• Report Number: 1037955-2025-00043
• Device Sequence Number: 9012895
• 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: 505
• Type of Report: Initial
• Report Date (Section B): 12/30/2025

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: F3725S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/05/2025
• Initial Report FDA Received Date: 12/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/30/2025
• 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: 57 YR
• Patient Sex: Female