MAUDE Adverse Event Report: DORNIER MEDTECH AMERICA INC. DORNIER SMARTFLEX; 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
This investigation was conducted in response to a customer stating that during a treatment, there was a crackling sound near the device connection.A device history record review was conducted and confirmed that there were no deviations or variances in manufacturing and the product met all dmta specifications.Past complaints were reviewed and at this time, there is no trend identified.The suspect fiber did not return within the time frame of this investigation for evaluation; once the fiber is delivered and evaluated, this report will be amended with the additional information.A fiber burn is identified as a medium level risk.There was no patient impact as a result of this malfunction.At this time, no further actions are necessary.
Event or Problem Description
Dmta received a report stating that during a procedure, a crackling sound was heard from the fiber at its connection to the laser.Immediately afterward, the pilot light went out and the treatment was haulted.
Additional Manufacturer Narrative
The device was returned to dmta for evaluation, and it was determined that there were no manufacturing defects that could have caused the malfunction.Upon evaluating the fiber, it was discovered that it originated from a different lot than originally reported.This has been corrected in this follow-up report.A device history record (dhr) review was conducted for the updated suspect fiber lot.No deviations or variances were found during manufacturing.The product underwent 100% power testing prior to release, confirming functionality.Evidence of a fiber burn was confirmed.The most likely root cause was improper user handling, not a manufacturing defect or inconsistency.

• 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
• MDR Report Key: 22890669
• Report Number: 1037955-2025-00030
• Device Sequence Number: 13001297
• Product Code: GEX
• UDI-Device Identifier: 04049958003165
• UDI-Public: (01)04049958003165
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Distributor
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2025

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: K2013162
• Device Catalogue Number: K2013162
• Device Lot Number: F3124R
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/28/2025
• Supplement Date Received by Manufacturer: 09/08/2025
• Initial Report FDA Received Date: 08/25/2025
• Supplement Report FDA Received Date: 09/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/22/2024
• 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 Sex: Unknown