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)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device returned for evaluation was reviewed and it was confirmed that the fiber was broken at the proximal sma connector, likely due to burn damage which was also observed.The burn damage revealed was likely the cause of the "internal loose parts" described by the complainant.Upon review, the laser fiber did not exhibit any manufacturing defects or inconsistencies.It was noted upon review of the rfid information that the laser fiber was utilized for just over 2000j, which provides objective evidence the laser fiber was at least operating as intended prior to failure.It is recognized that all laser fibers manufactured by dornier medtech america are subject to 100% inspection for visual defects as well as power performance testing which confirms the device is operating within specification.It is not possible to confirm the root cause of the burn damage identified, however, it is possible to state this damage was not likely to have been caused by any factor related to the manufacturing of the device.
Event or Problem Description
A holmium fiber was reported to have a defect with, "loose internal parts".

• 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: 19783870
• Report Number: 1037955-2024-00026
• Device Sequence Number: 18170425
• Product Code: GEX
• UDI-Device Identifier: 04049958003165
• UDI-Public: 01040499580031651728071210F2712R
• 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): 07/19/2024

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: F2723R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/19/2024
• Initial Report FDA Received Date: 07/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/12/2023
• 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