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

Model Number	K2013062
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No devices were returned within the duration of this investigation.The device identified by the complaint information has not been received for evaluation.The 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.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 holmium laser fiber which was reported to have broken, "a urs treatment has been conducted in which a laser fiber was broken".
Additional Manufacturer Narrative
One laser fiber was returned for evaluation based on the complaint as reported.The laser fiber returned was confirmed to be item k2013062 lot f2723s, and was confirmed to be broken as described by the complainant.Upon verification of the rfid, it was revealed the laser was power performance tested acceptably by dmta personnel, confirming the acceptable operation of the device.Additionally, a small amount of usage was recorded on the laser fiber, indicating perhaps a mechanical force placed on the laser fiber occurred early on during operation.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 manufacturing defects were revealed.
Event or Problem Description
Dmta quality was contacted regarding a holmium laser fiber which was reported to have broken.

• Brand Name: DORNIER MEDTECH AMERICA, INC.
• Common Device Name: HOLMIUM 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 30188
• MDR Report Key: 20268353
• Report Number: 1037955-2024-00038
• Device Sequence Number: 3531284
• Product Code: GEX
• UDI-Device Identifier: 04049958003097
• UDI-Public: 01040499580030971728070710F2723S
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2024

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: K2013062
• Device Lot Number: F2723S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/23/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/20/2024
• Supplement Report FDA Received Date: 11/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/07/2023
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown