MAUDE Adverse Event Report: ROHRER AESTHETICS, INC. SPECTRUM; POWERED LASER SURGICAL INSTRUMENT

Model Number	SPECTRUM
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Unintended Electrical Shock (4018)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/31/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was replaced at user facility.Full set of testing was done after affected device was returned to manufacturing facility and the problem could not be duplicated.The system passed all tests.An aro form fda 2649 was submitted on 4/27/26.
Event or Problem Description
User received an electrical shock from the handpiece of the spectrum device after installing a replacement part.The user installed a replacement part onto the unit, made contact with the cooling plate on the handpiece to assess whether cooling was functioning properly.Upon contact, the user reported experiencing an electrical shock in the hand, with sensation traveling up the arm and into the chest.Immediately after the incident, the user reported feeling lightheaded and dizzy.The user presented to the emergency room, where an ekg was performed with normal results and no additional abnormalities identified.The user reported that the shcok did not result in any visible skin damage and there was no burn marks present.

• Brand Name: SPECTRUM
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): ROHRER AESTHETICS, INC.; 121 citation court; homewood 35209
• Manufacturer (Section G): ROHRER AESTHETICS, INC.; 121 citation court; homewood 35209
• Manufacturer Contact: sandra hansen ; 121 citation court; homewood 35209 ; 9255503094
• MDR Report Key: 25006453
• Report Number: 3031944951-2026-00004
• Device Sequence Number: 8764972
• Product Code: GEX
• UDI-Device Identifier: 00860564000317
• UDI-Public: (01)00860564000317
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K123777
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 04/27/2026

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: SPECTRUM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/31/2026
• Initial Report FDA Received Date: 04/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/11/2018
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown