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

Model Number	K2013151
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
Event or Problem Description
Two holmium laser fibers reportedly burned during use.
Additional Manufacturer Narrative
No units were returned to dmta within the timeframe of this investigation.It is not possible to confirm the root cause of the complaint as reported without access to the devices in question.However, one of the units identified is ackonwledged to have been reportedly utilized 12 times, which is outside of the approved use limit of 10 uses.The customer was notified of the use limit and instructed to review the valid instructions for use for confirmation regarding the use limit.It is acknowledged there could be many root causes for the complaint information received, fiber burn.It is also acknowledged that all laser fibers manufactured by dmta are 100% inspected for power performance defects, objectively providing confirmation the fibers are operating as intended prior to distribution.No trend for complaints related to this matter is currently observed.Dornier will continue to monitor complaints related to this report.

• 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 30144 ; 7705146204
• MDR Report Key: 17607281
• Report Number: 1037955-2023-00029
• Device Sequence Number: 6161882
• Product Code: GEX
• UDI-Device Identifier: 04049958003158
• UDI-Public: 01040499580031581727111110F4522R
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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): 07/24/2023

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: K2013151
• Device Lot Number: F4522R
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/24/2023
• Initial Report FDA Received Date: 08/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/11/2022
• 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