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

Model Number	K2311580
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
Diode laser fiber burn reported.
Additional Manufacturer Narrative
No unit was returned to dmta within the timeframe of this investigation.The suspect device was not indicated to be obtainable.It is not possible to confirm the root cause of the complaint as reported without access to the device in question.It is acknowledged there could be many root causes for the complaint information received.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: DIODE 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: 17567058
• Report Number: 1037955-2023-00028
• Device Sequence Number: 20499453
• Product Code: GEX
• UDI-Device Identifier: 00810116022588
• UDI-Public: 01008101160225881727061510C2322S
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K021724
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/18/2023

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: K2311580
• Device Lot Number: C2322S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/18/2023
• Initial Report FDA Received Date: 08/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2022
• 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: Unknown
• Patient Sequence Number: 1
• Patient Age: 83 YR
• Patient Sex: Male