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

Model Number	SLIM 270 MICRON SINGLE USE THULIO PERFORMANCE FIBER
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This investigation was conducted in response to a customer report of problems with fibers crackling and becoming unattached from the laser during procedures.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.One of the suspect fibers was evaluated and it was confirmed to be burnt.Based on the information received, there could be multiple contributing factors to this malfunction like the laser is out of alignment or incorrect user handling.There were no defects identified in the manufacturing process related to this complaint.A fiber burn is identified as a medium-level risk.There was no patient impact as a result of this malfunction.At this time, no further actions by dmta are determined to be necessary.
Event or Problem Description
Dmta received a customer complaint that fibers would crackle and disconnect from the laser during procedures.

• 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
• MDR Report Key: 23916741
• Report Number: 1037955-2025-00040
• Device Sequence Number: 21092098
• Product Code: GEX
• UDI-Device Identifier: 00810116023271
• UDI-Public: (01)00810116023271
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 12/29/2025

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: SLIM 270 MICRON SINGLE USE THULIO PERFORMANCE FIBER
• Device Catalogue Number: K2016361
• Device Lot Number: F3425S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2025
• Initial Report FDA Received Date: 12/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/04/2024
• 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 Sex: Unknown