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

Model Number	TRUSCULPTID
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Partial thickness (Second Degree) Burn (2694)
Date of Event	08/26/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient received a trusculpt id treatment to her abdomen and flanks.The device operator reported that within the first minute, the patient complained of a hot sensation on her back.The device operator paused the treatment and checked the return pads that were placed on the patient's upper back.The treatment was restarted, and the patient appeared comfortable for the remainder of the session, with no further complaints.Two days after the treatment, the patient reported a blister to the clinic.The clinic provided a photo showing a small, deep dermal thickness burn in the center of the patient's back.The clinic is providing wound care to the patient but declined to specify the specific wound care being provided for the burn.The return pad cables will be sent back to cutera for further evaluation.
Event or Problem Description
This is a follow-up to the initial emdr filed on october 1, 2024.As initially reported, the patient received a trusculpt id treatment to her abdomen and flanks.The device operator reported that within the first minute, the patient complained of a hot sensation on her back.The device operator stated that she paused the treatment and checked the return pads that were placed on the patient's upper back and then restarted the treatment.The patient appeared comfortable for the remainder of the session, with no further complaints.Two days after the treatment, the patient reported a blister to the clinic.The clinic provided a photo showing a small, deep dermal thickness burn in the center of the patient's back.The clinic is providing wound care to the patient but declined to specify the specific wound care being provided for the burn.At the time of the initial emdr, cutera was awaiting return of the return pad cables.The return pad cables have since been received and tested, and they were determined not to have caused or contributed to the event.In addition, the error log and rf log were reviewed, and there were no errors nor pauses during the treatment.It is unclear why the device operator reported that she paused treatment to check the return pads.The most likely root cause for the burn on the patient's back is that the return pads were applied with the patient arching forward, contrary to the instructions for use.When the patient then laid flat, a fold or crease formed under the center-most adhesive surrounding the return pad, allowing sweat to accumulate in a fold or crease prior to the treatment beginning.When the treatment began, the sweat essentially extended the size of the return pad electrode in that location, allowing more of the return current to exit the patient nearer to her spine where the fat thickness is less than under her central back where the return pad was located.An investigation report has been finalized and filed in cutera's complaints handling system.

• 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: 20349004
• Report Number: 2954354-2024-00016
• Device Sequence Number: 7931442
• Product Code: GEI
• UDI-Device Identifier: 00816722021427
• UDI-Public: 010081672202142711181114
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K223110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician Assistant
• Type of Report: Initial,Followup
• Report Date (Section B): 10/07/2024

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: Health Professional
• Device Model Number: TRUSCULPTID
• 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: 09/12/2024
• Supplement Date Received by Manufacturer: 09/12/2024
• Initial Report FDA Received Date: 10/01/2024
• Supplement Report FDA Received Date: 10/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/14/2018
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White