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

Model Number	HOL270S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported in medwatch form mw5186236 that a tip of the fiber broke in the patient.The piece was extracted with a basket.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.
Event or Problem Description
Dmta received a medwatch form stating that the tip of a fiber had broken off inside a patient.The broken piece was extracted and there was no harm to the patient reported.

• 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: 25175805
• Report Number: 1037955-2006-00013
• Device Sequence Number: 10643664
• Product Code: GEX
• UDI-Device Identifier: 00810116020355
• UDI-Public: 00810116020355
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K121938
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2026

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: HOL270S
• Device Catalogue Number: HOL270S
• Device Lot Number: F3325S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/24/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/14/2026
• Supplement Report FDA Received Date: 05/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/09/2025
• 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: 73 YR
• Patient Sex: Female
• Patient Weight: 59 KG
• Patient Race: White