MAUDE Adverse Event Report: CUTERA, INC. TRUSCULPT ID; ELECTROSURGICAL CUTTING AND COAGULATION DEVICE AND ACCESSORIES

Model Number	TRUSCULPT ID
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Partial thickness (Second Degree) Burn (2694); Skin Infection (4544)
Date of Event	05/04/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2022, a customer reported that about 1 min into a lower abdominal fat reduction treatment with the trusculpt id device delivered 5 days prior (b)(6) 2022) to a high bmi patient, the device stopped delivering rf energy and displayed two error codes.The customer exchanged the console ports to which handsfree-handpieces 1 and 2 were connected to from ports 1 and 2 to ports 2 and 1, respectively, and resumed the treatment.At the end of the 15 min treatment, when all 6 handpieces in use were being removed, the customer noticed the patient had a 5 cm x 1.5 cm linear blister under the right edge of handpiece 1 and two smaller circular blisters centered under handpiece 2.The customer gave the patient topical antibiotic ointment to uses as needed to keep the burns moist during healing.When the patient returned to the clinic for a follow-up visit on (b)(6) 2022, the 5 cm x 1.5 cm blister was partially unroofed in two locations and all blisters appeared to be becoming infected.The customer referred the patient to a dermatologist who prescribed 500 mg keflex bid to treat the infection, and subsequently the patient visited an er where bactrim was added.Since medical intervention was required to treat the infection which developed in partial-thickness burns, the event is reportable.

• Brand Name: TRUSCULPT ID
• Common Device Name: ELECTROSURGICAL CUTTING AND COAGULATION DEVICE AND ACCESSORIES
• Manufacturer (Section D): CUTERA, INC.; 3240 bayshore boulevard; brisbane CA 94005
• Manufacturer (Section G): CUTERA, INC.; 3240 bayshore boulevard; brisbane CA 94005
• Manufacturer Contact: bradley renton ; 3240 bayshore boulevard; brisbane, CA 94005 ; 4156575568
• MDR Report Key: 14628448
• Report Number: 2954354-2022-00003
• Device Sequence Number: 6074718
• Product Code: PBX
• UDI-Device Identifier: 00816722021427
• UDI-Public: 010081672202142711211130
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K180709
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Repair
• Type of Report: Initial
• Report Date (Section B): 06/07/2022

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: TRUSCULPT ID
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/09/2022
• Initial Report FDA Received Date: 06/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/01/2021
• 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: 40 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White