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

Model Number	TRUSCULPT ID
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	04/12/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Full and partial thickness burns at connection point between the return cable and bovie neutral electrode.
Additional Manufacturer Narrative
User facility reported a significant burn (small full-thickness surrounded by a larger partial thickness) on the lower edge of the bovie neutral electrode pad tab found immediately after an rf treatment for abdominal fat reduction.Immediately post-treatment photos and photos taken at follow-up visits through 38 post treatment were provided.It is apparent from the immediate post-treatment photo of the full-thickness burn (2.0 cm width x 0.4 cm length) and surrounding partial-thickness burn (~4 cm width x ~1 cm length) that, contrary to the ifu, the return cable clamp was not fully covering the exposed bare-metal conductors of split-electrode bovie neutral electrode pad tab.The full-thickness burn exactly matched in location, width, and length the imprint of the neutral electrode pade and tab in the patient's skin, and extended from the hydrogel-coated edge of the tab conductors to the point (4 mm below) where the bare-mental conductors were covered by the return cable clamp.

• 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: 14628450
• Report Number: 2954354-2022-00002
• Device Sequence Number: 17670638
• Product Code: PBX
• UDI-Device Identifier: 00816722021427
• UDI-Public: 010081672202142711190520
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 06/03/2022

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?: No
• Operator of Device: Health Professional
• Device Model Number: TRUSCULPT ID
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/03/2022
• Initial Report FDA Received Date: 06/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/20/2019
• 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: 66 YR
• Patient Sex: Female
• Patient Race: Black Or African American