MAUDE Adverse Event Report: SUMMUS LASER MEDICAL LLC PLATINUM 4 MEDICAL LASER; P4

Model Number	P4
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	Superficial (First Degree) Burn (2685)
Date of Event	05/09/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complaint (b)(4).Doctor claims that the burn occured on his arm due to a broken fiber assembly - the fiber assembly was not received for investigation - however the laser device was returned and this was evaluated.It was concluded that there was dust in the module and this caused the module to have no output and was burn.The fiber assembly was burned and upon inspection of the module it was burnt, this is seen when there is dust in the beam path the dust can combust and cause burning of the fiber assembly, when the fiber assembly is removed dust is allowed to enter the module and when the fiber assembly is attached back to the device the dust will heat up and combust causing the fiber assembly to burn and no longer function.The doctor did not return the broken fiber assembly and no photos were provided of the burn.Follow up with the doctor was performed and he stated he was healing without additional medical intervention.The injury can not be confirmed but the fiber assembly would have broken due to dust in the module - the owner manual states not to remove the fiber assembly in order to avoid dust build up.
Event or Problem Description
User (doctor) was burned by broken fiber assembly, fiber assembly broke at the base of teh hand piece and burned doctor.

• Brand Name: PLATINUM 4 MEDICAL LASER
• Common Device Name: P4
• Manufacturer (Section D): SUMMUS LASER MEDICAL LLC; 1185 w. main st; franklin TN 37064
• Manufacturer (Section G): SUMMUS MEDICAL LASER LLC; 1185 west main st; franklin TN 37064
• Manufacturer Contact: richard albright ; 1185 west main st; franklin, TN 37064
• MDR Report Key: 22190745
• Report Number: 3006120071-2025-00001
• Device Sequence Number: 8593852
• Product Code: ILY
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/11/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: P4
• Device Catalogue Number: P4
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2025
• Initial Report FDA Received Date: 06/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/18/2019
• Is the Device Labeled for Single Use? (Y/N): No
• 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