MAUDE Adverse Event Report: CUTERA, INC. TRUSCULPT ID; MASSAGER, VACUUM, RADIO FREQUENCY INDUCED HEAT

Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	Partial thickness (Second Degree) Burn (2694); Full thickness (Third Degree) Burn (2696)
Date of Event	02/15/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The adverse event questionnaire sent to and completed by the customer after the event was reported was returned along with photos of the burn taken several minutes and 1 and 2 days after it occurred.In the immediate posttreatment photo, clear imprints in the patient's skin made by the edges of the split-electrodes and adhesive-coated white fabric backing of the bovie return pad and an adjacent 40 cm2 handpiece (electrode and housing) can be seen.These imprints show exactly where the return pad and handpiece were positioned during the treatment and the location of the burn.A 10 mm x 3 mm crescent-shaped white-appearing burn can be seen on the patient's upper-right back beginning exactly at the top-right curved edge of the return pad's neutral split electrode and extending under the return pad's fabric backing towards the edge of the 40 cm2 handpiece <2 mm from the return pad's fabric backing.It is certain a large portion of the rf current from this 40 cm2 handpiece conducted the short distance (10-12 mm) through the patient's skin to enter the neutral electrode concentrated at its closest curved edge rather than through the skin (2-3 mm) and subcutaneous fat (>8 mm) underlying the handpiece and then through the highly conductive internal body fluids and tissues before entering the neutral electrode evenly over its full surface area.The root cause of the adverse event was user error - failure to follow ifu; 1 or more 40 cm2 handpieces placed with insufficient separation from the return pads.
Event or Problem Description
A 10 mm x 3 mm crescent-shaped deep partial thickness/full thickness burn occurred at the top right corner of the return electrode pad on the patient's upper back.The root cause was determined to be insufficient separation between the return pad and the nearest handpiece.There is not a device performance complaint associated with the event.

• Brand Name: TRUSCULPT ID
• Common Device Name: MASSAGER, VACUUM, RADIO FREQUENCY INDUCED HEAT
• Manufacturer (Section D): CUTERA, INC.; 3240 bayshore blvd.; brisbane CA 94005
• Manufacturer (Section G): CUTERA, INC.; 3240 bayshore blvd.; brisbane CA 94005
• Manufacturer Contact: julia brown ; 3240 bayshore blvd.; brisbane, CA 94005 ; 4156575575
• MDR Report Key: 18926256
• Report Number: 2954354-2024-00003
• Device Sequence Number: 9291096
• Product Code: GEI
• UDI-Device Identifier: 00816722021427
• UDI-Public: 00816722021427
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K221407
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/18/2024

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: Other
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2024
• Initial Report FDA Received Date: 03/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/20/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 32 YR
• Patient Sex: Female