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

Model Number	K2013151
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This investigation was initiated after a customer reported that a physician observed a break in the fiber upon removing it from the packaging, prior to use.A device history report review was conducted and the suspect fiber was manufactured without variances or deviations.The fiber was power tested before release, confirming the operational capacity of the fiber.The suspect fiber was not available for evaluation in the timeframe of this investigation.A trend analysis was conducted, and at this time, there is no trend identified for complaints related to holmium fibers breaking.The root cause cannot be determined at this time.
Event or Problem Description
Dmta received a report that a physician observed a break in the holmium fiber upon removing it from the packaging, prior to use.

• Brand Name: DORNIER SMARTFLEX HIGH ENERGY
• 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 ; 4072024117
• MDR Report Key: 23794561
• Report Number: 1037955-2025-00038
• Device Sequence Number: 10470688
• Product Code: GEX
• UDI-Device Identifier: 04049958003158
• UDI-Public: 04049958003158
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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: User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2025

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: K2013151
• Device Catalogue Number: K2013151
• Device Lot Number: F0125R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/19/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/12/2025
• Supplement Report FDA Received Date: 12/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/20/2025
• 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: Initial
• Patient Sequence Number: 1
• Patient Age: 45 YR
• Patient Sex: Female