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

Model Number	K2013162
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device identified by the complaint information was received for evaluation 11 nov 2024 and was evaluated (b)(6) 2024.The laser fiber returned was determined to be broken, consistent with information received from the complainant.The laser fiber rfid tag revealed the device had been utilized by the complainant for 1370j of energy transmission.The usage of the fiber by the complainant prior to breakage observed, as well as the 100% inspection completed at dmta provide objective evidence the laser fiber was operating within specification prior to the breakage 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.It is acknowledged the customer claimed that the "bend" (break) was noted following resterilization, it is possible the handling if improper during this process contributed to a breakage of the laser fiber as reported.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 sample.
Event or Problem Description
On (b)(6) 2024 dmta quality was contacted regarding a holmium laser fiber which was reported to have broken.No patient impact was reported as a result of the complaint experience.The customer stated regarding the complaint, "after cleaning the fiber once, the fiber was bent.".

• 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 30144
• MDR Report Key: 21069431
• Report Number: 1037955-2024-00054
• Device Sequence Number: 20953356
• Product Code: GEX
• UDI-Device Identifier: 04049958003165
• UDI-Public: 01040499580031651728011310F0123R
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 01/02/2025

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
• Device Model Number: K2013162
• Device Lot Number: F0123R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/06/2024
• Initial Report FDA Received Date: 01/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/13/2023
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown