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	12/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device identified by the complaint information was not received for evaluation during the timeframe of this complaint investigation and a review of the suspect device was therefore not possible.It is acknowledged that every laser fiber manufactured by dmta is subject to a 100% inspection for visual and power performance which confirms each laser fiber is operating within specification prior to distribution.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 likely root cause of the fiber break reported was a mechanical force placed on the fiber.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 9 december 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, "h35 machine couldn't detect fiber when connected and fiber suddenly broke on its own intraoperatively.".

• 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: 21097783
• Report Number: 1037955-2024-00057
• Device Sequence Number: 15636467
• Product Code: GEX
• UDI-Device Identifier: 04049958003165
• UDI-Public: 01040499580031651728011310F0123R
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K123385
• 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
• Report Date (Section B): 01/06/2025

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?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/09/2024
• Initial Report FDA Received Date: 01/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown