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

Model Number	K2016361
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
No device was returned within the duration of this investigation.The device identified by the complaint information has not been received for evaluation.The state of the device and/or a root cause of the complaint as reported was not possible to confirm.However, 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.Additionally, all laser fibers manufactured at dmta are subject to 100% power performance testing, which verifies the devices are operating as intended.Should a laser fiber be returned allowing further analysis, details concerning the evaluation will be provided in a follow up report.
Event or Problem Description
Dmta quality was contacted regarding a thulio laser fiber which was reported to have failed stating the device, "broke.".

• 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: 20480905
• Report Number: 1037955-2024-00040
• Device Sequence Number: 8266812
• Product Code: GEX
• UDI-Device Identifier: 00810116023271
• UDI-Public: 01008101160232711728033110F1323S
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/17/2024

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: K2016361
• Device Lot Number: F1323S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/17/2024
• Initial Report FDA Received Date: 10/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/31/2023
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown