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

Model Number	K2013161
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that two fibers from the same lot broke during two different procedures.The first fiber broke after approximately 14 seconds of use.The second fiber reportedly broke after approximately two seconds of use.In both procedures, an additional fiber was used and the procedures were completed successfully.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 no identifiable trend related to holmium fibers breaking was found.The risk associated with a fiber break is classified as medium.No evidence of a manufacturing deficiency was identified during this investigation.The root cause could not be determined because the suspect fiber was not available for evaluation.
Event or Problem Description
It was reported that two fibers from the same lot broke during two different procedures.The first fiber broke after approximately 14 seconds of use.The second fiber reportedly broke after approximately two seconds of use.In both procedures, an additional fiber was used and the procedures were completed successfully.

• Brand Name: DORNIER SINGLEFLEX
• 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: 25444680
• Report Number: 1037955-2006-00020
• Device Sequence Number: 5815407
• Product Code: GEX
• UDI-Device Identifier: 04049958003103
• UDI-Public: 04049958003103
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K152591
• 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): 06/09/2026

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: K2013161
• Device Lot Number: F3525S
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/21/2026
• Initial Report FDA Received Date: 06/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/23/2025
• 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 Sex: Unknown