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

Model Number	270 MICRON HOLMIUM LASER FIBER CABLE, SINGLE USE, RFID (SLIM)
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspect device was disposed of and not available to dmta for evaluation.At this time, it is not possible to determine the root cause of this complaint.All fibers are subject to 100% inspection for visual defects and power performance testing to confirm the product is operating within specifications prior to release.
Event or Problem Description
Dmta received a complaint stating that a fiber was noted with a charred tip during a procedure.

• Brand Name: DORNIER SINGLEFLEX 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: 23439738
• Report Number: 1037955-2025-00037
• Device Sequence Number: 4782837
• Product Code: GEX
• UDI-Device Identifier: 04049958003103
• UDI-Public: (01)04049958003103
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K152591
• 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): 10/31/2025

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: 270 MICRON HOLMIUM LASER FIBER CABLE, SINGLE USE, RFID (SLIM)
• Device Catalogue Number: K2013161
• Device Lot Number: F4124S
• 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: 10/24/2025
• Initial Report FDA Received Date: 10/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/10/2024
• 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