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	10/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device identified by the complaint information was received for evaluation 4 nov 2024 and was evaluated 20 nov 2024.The laser fiber returned was determined to be broken, consistent with information received from the complainant.The laser fiber rfid revealed the device had been utilized four times, with over 3500j total energy transmission.The usage by the complainant prior to breakage 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.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 30 october 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 reported fiber failure.

• 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: 20825232
• Report Number: 1037955-2024-00046
• Device Sequence Number: 12993995
• Product Code: GEX
• UDI-Device Identifier: 04049958003165
• UDI-Public: 01040499580031651728011310F0123R
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: K2013162
• Device Lot Number: F0123R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/30/2024
• Initial Report FDA Received Date: 12/02/2024
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown