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

Model Number	DORNIER SMARTFLEX REUSABLE LIGHT GUIDE
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
It was reported that a fiber showed signs of burning and splitting at the blue tip.The dhr review confirmed that the fiber met all quality requirements prior to release.The fiber was not returned to dmta for evaluation and all other fibers from the suspect lot have been distributed.Past complaints were reviewed, and there is no identifiable trend in complaints related to holmium fibers burning.The risk associated with a fiber burning at the connector is identified as medium.Based on the available evidence, several factors may have contributed to this malfunction, including possible handling-related elements and other clinical use conditions.
Event or Problem Description
Dmta received a complaint stating that a fiber showed signs of burning and splitting at the blue tip.

• Brand Name: DORNIER SMARTFLEX LASER FIBER
• Common Device Name: HOLMIUM LASER FIBER CABLE
• 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: edward grammer ; 1155 roberts blvd; suite 100; kennesaw, GA 30144 ; 7704261315
• MDR Report Key: 24895548
• Report Number: 1037955-2026-00008
• Device Sequence Number: 16089364
• Product Code: GEX
• UDI-Device Identifier: 04049958003165
• UDI-Public: (01)04049958003165
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 04/16/2026

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
• Operator of Device: Health Professional
• Device Model Number: DORNIER SMARTFLEX REUSABLE LIGHT GUIDE
• Device Catalogue Number: K2013162
• Device Lot Number: F4924R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2026
• Initial Report FDA Received Date: 04/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/07/2025
• 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