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)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that a thulio laser fiber broke during a procedure, there was no patient impact and they completed the procedure with a new fiber.The dhr review confirmed that the suspect fiber was manufactured without variances or deviations.The suspect fiber was evaluated and demonstrated evidence that the tip of the fiber had broken off.Past complaints were reviewed, and there is no identifiable trend in complaints related to thulio fibers breaking.The risk related to a fiber break is identified as medium.No definitive root cause could be determined.Potential contributing factors may include user handling or clinical-use conditions.No corrective actions were determined to be mandatory as a result of this investigation.The results of this investigation identified no manufacturing defects or quality system inconsistencies associated with the subject device.
Event or Problem Description
Dmta received a report that a fiber broke during a procedure.
Additional Manufacturer Narrative
It was reported that a thulio laser fiber broke during a procedure, there was no patient impact and they completed the procedure with a new fiber.The dhr review confirmed that the suspect fiber was manufactured without variances or deviations.The suspect fiber was evaluated and demonstrated evidence that the fiber had broken into (b)(4) pieces.There was discoloration on the severed section of fiber as well as the heat shrink.It appears the fiber had been broken prior to activation then fired, which resulted in complete separation into two pieces.Past complaints were reviewed, and there is no identifiable trend in complaints related to thulio fibers breaking.The risk related to a fiber break is identified as medium.Based on the available evidence and review of ha-005, the probable root cause is user handling or clinical-use conditions.This amendment is being submitted because the original evaluation was performed on a fiber that was not the correct suspect fiber for this complaint.The supplier subsequently provided the correct suspect fiber for evaluation.

• 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: 24501218
• Report Number: 1037955-2026-00004
• Device Sequence Number: 10440591
• Product Code: GEX
• UDI-Device Identifier: 00810116023462
• UDI-Public: 00810116023462
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K123385
• 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,Followup
• Report Date (Section B): 05/06/2026

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: K2016370
• Device Lot Number: F0525R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/06/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/03/2026
• Supplement Report FDA Received Date: 05/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Sex: Unknown