MAUDE Adverse Event Report: BIOS SRL NUERA TIGNT; RADIO-FREQUENCY SKIN CONTURING SYSTEM

Model Number	CO2 SURGICAL DEVICE
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	02/14/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Lumenis investigated the reported event by contacting the user facility directly.Attempts by emails and phone calls have been made to obtain; patient treatment settings, patient information, patient photo.Customer reported side affects during treatment, dehydration, sore after treatment on right hand and left shoulder.The device nuera1.2 ga-5200000us:(b)(4) was installed in the facility on 8/31/2022 and it's still in warranty.Service engineer contacted customer on 02/17/2023 and advised: "from talking to the customer, the unit appeared to be working in the proper manner and correctly".Because of the lack of information (no incident form received) lumenis is reporting the event to the fda in an 'abundance of caution'.Should additional significant information become available, the complaint record will be updated accordingly and a follow-up medwatch report will be submitted.
Event or Problem Description
Lumenis received an adverse event report on a patient who sustained injury following treatment by nuera 1.2 device.

• Brand Name: NUERA TIGNT
• Common Device Name: RADIO-FREQUENCY SKIN CONTURING SYSTEM
• Manufacturer (Section D): BIOS SRL; via guido rossa 10/12; vimodrone 20090; 20090 ; IT 20090
• MDR Report Key: 16544279
• Report Number: 3020611964-2023-00003
• Device Sequence Number: 17772402
• Product Code: PBX
• UDI-Device Identifier: 08052049500111
• UDI-Public: 08052049500111
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/15/2023

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: CO2 SURGICAL DEVICE
• Device Catalogue Number: GA-50000US
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 6 MO
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/15/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic