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

Model Number	600 MICRON SU THULIO PERFORMANCE 3M FIBER
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This investigation was conducted in response to medsun report, (b)(4), where the user states they heard crackling and saw smoke coming from the laser fiber as it was connected to the laser.A device history record review was conducted and confirmed that there were no deviations or variances in manufacturing and the product met all dmta specifications.Past complaints were reviewed and at this time, there is no trend identified.The suspect fiber is unavailable for evaluation.Based on the information received, it is not possible to identify a root cause but there are several possibilities such as: the laser is out of alignment or incorrect user handling or reprocessing; this was a single use fiber that the user claimed to have reprocessed and reused on a patient which is not an authorized use of the device per the instructions for use.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 medsun report, (b)(4), where the user states they heard crackling and saw smoke coming from the laser fiber as it was connected to the laser.

• 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: 23009542
• Report Number: 1037955-2025-00034
• Device Sequence Number: 21258343
• Product Code: GEX
• UDI-Device Identifier: 00810116023318
• UDI-Public: (01)00810116023318
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K121938
• 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): 09/09/2025

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: 600 MICRON SU THULIO PERFORMANCE 3M FIBER
• Device Catalogue Number: K2016365
• Device Lot Number: C1324S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2025
• Initial Report FDA Received Date: 09/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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): Yes
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Sex: Unknown