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

Model Number	K2016370
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The devices identified by the complaint information were received for evaluation 20 nov 2024 and were evaluated 22 nov 2024.The laser fibers returned were determined to be broken, consistent with information received from the complainant.The laser fibers rfid tags revealed the devices had both been utilized by the complainant.One of the fibers had been utilized four times with a total energy transmission of 17670j, and the other had been utilized for one case with a total energy transmission of 6600j.The usage of both fibers by the complainant prior to breakages observed, as well as the 100% inspection completed at dmta provide objective evidence the laser fibers were operating within specification prior to the breakages reported.It is acknowledged that dornier laser fibers are fragile, and must be handled with care as instructed in the applicable instructions for use for laser fibers.No patient or operator impact was reported with information received for this complaint.No defects or inconsistencies with the laser fiber returned were noted upon evaluation of the complaint samples.
Event or Problem Description
On 5 november 2024 dmta quality was contacted regarding a thulio laser fiber which was reported to have broken on 26 september 2024.No patient impact was reported as a result of the reported fiber breakage.

• Brand Name: DORNIER MEDTECH AMERICA, INC.
• 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: amber stallings ; 1155 roberts blvd; suite 100; kennesaw, GA 30144
• MDR Report Key: 20825260
• Report Number: 1037955-2024-00047
• Device Sequence Number: 8717110
• Product Code: GEX
• UDI-Device Identifier: 00810116023462
• UDI-Public: 01008101160234621728073110F2923R
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K121938
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 11/26/2024

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
• Device Model Number: K2016370
• Device Lot Number: F2923R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/05/2024
• Initial Report FDA Received Date: 12/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/31/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown