MAUDE Adverse Event Report: DORNIER MEDTECH AMERICA, INC. DORNIER MEDTECH; POWERED LASER SURGICAL INSTRUMENT

Model Number	270 MICRON SINGLE USE HE
Health Effect - Clinical Code	Superficial (First Degree) Burn (2685)
Date of Event	05/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Laser fiber broke and burned the resident's hand.

• Brand Name: DORNIER MEDTECH
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): DORNIER MEDTECH AMERICA, INC.; 1155 roberts blvd; suite 100; kennesaw GA 30144
• MDR Report Key: 22169254
• Report Number: 22169254
• Device Sequence Number: 15766819
• Product Code: GEX
• UDI-Device Identifier: 00810116020744
• UDI-Public: (01)00810116020744
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 06/05/2025
• Report Date (Section F): 06/05/2025

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
• Device Model Number: 270 MICRON SINGLE USE HE
• Device Catalogue Number: HOL270SHE
• Device Lot Number: F3724S
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 06/09/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/09/2025
• 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 Age: 80 YR
• Patient Sex: Male
• Patient Weight: 109 KG
• Date Report Sent to FDA: 06/05/2025