MAUDE Adverse Event Report: DORNIER MEDTECH AMERICA INC.; Powered laser surgical instrument

Lot Number	F2925S
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that during a surgical procedure, a defect was identified in a new laser fiber, characterized by charring at the base of the connector.This report originated from anvisa, and much of the information was kept confidential, limiting the precision of this investigation.A review of the device history records confirmed that the potential suspect products were manufactured without variances or deviations and met all applicable quality requirements prior to release.The suspect product was not available for evaluation during the timeframe of this investigation.Past complaints were reviewed, and no identifiable trend was found for dmta-manufactured laser fibers burning.The risk associated with a fiber burn at the connector is identified as medium in ha-005.The root cause of this complaint could not be determined without evaluation of the suspect product.
Event or Problem Description
It was reported that during a surgical procedure, a defect was identified in a new laser fiber, characterized by charring at the base of the connector.This report originated from anvisa, and much of the information was kept confidential, limiting the precision of this investigation.

• Common Device Name: Powered laser surgical instrument
• 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: 25535813
• Report Number: 1037955-2026-00022
• Device Sequence Number: 9175279
• Product Code: GEX
• UDI-Device Identifier: 00810116020744
• UDI-Public: (01)00810116020744
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 06/17/2026

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
• Device Lot Number: F2925S
• 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: 05/28/2026
• Initial Report FDA Received Date: 06/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown