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

Model Number	K2013162
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Dmta received a customer complaint that the head of the fiber detached from the rest of the fiber.No patient harm was reported.
Additional Manufacturer Narrative
It was reported the head of the fiber detached from the rest of the fiber.The dhr review confirmed that the suspect fiber was manufactured without variances or deviations.The suspect fiber was unavailable for evaluation during the timeframe of this investigation.Past complaints were reviewed, and there is no identifiable trend in complaints related to holmium fibers breaking.The risk related to a fiber break is identified as medium.The root cause cannot be fully determined without evaluating the fiber.

• Brand Name: DORNIER SMARTFLEX
• 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: edward grammer ; 1155 roberts blvd; suite 100; kennesaw, GA 30144 ; 7704261315
• MDR Report Key: 25028184
• Report Number: 1037955-2006-00010
• Device Sequence Number: 10260667
• Product Code: GEX
• UDI-Device Identifier: 04049958003165
• UDI-Public: 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): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 04/29/2026

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: K2013162
• Device Catalogue Number: K2013162
• Device Lot Number: F4124R
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/09/2026
• Initial Report FDA Received Date: 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/14/2024
• 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