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); Skin Infection (4544)
Date of Event	05/26/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The bovie neutral electrode return pad, on which the full thickness burn occurred, was placed too low on the patient's back, with insufficient separation from the nearest treatment handpiece (~1.5 cm), with its lower 1 cm at the same height on the patient's back as the top 1 cm of adjacent handpiece, and hence over subcutaneous fat of the same thickness as under the treatment handpiece, all of which are contrary to the ifu.It is certain the majority of rf current delivered from the adjacent handpiece, rather than passing through the higher-impedance subcutaneous fat underlying the handpiece and conducting through highly-conductive body tissues before exiting the body (again through high-impedance subcutaneous fat) evenly over the full area of the return pad, conducted instead directly through the patient's skin and entered the return pad at its closest edge.The high current density at the rounded lower outer corner of the return pad closest to the handpiece rapidly heated the skin causing the crescent-shaped full thickness burn.
Event or Problem Description
On 5/31/2022, a med spa customer reported that during a treatment with the trusculpt id device for bra fat reduction using two bovie return pads positioned vertically just below the shoulder blades and four 40 cm2 handpieces, 2 on the patient's lateral midback left and right sides, respectively, after the 2 handpieces on the patient's left side had cycled once without issue, the patient reported significant heat/pain on the right side about 1 minute into the right-side handpieces' heating cycle (when the handpiece temperatures had reached 43c).The treatment was paused while right-side handpieces were "re-adjusted." the treatment was briefly resumed, with the patient again reporting significant heat/pain, before being aborted.When the right side bovie return pad was being removed, a small area of the patient's skin at the corner of the return pad closest to the immediately adjacent handpiece "lifted and pulled away with the bovie [return] pad." the provider "put bandages over it [the torn skin] and told her to keep us updated".The following day, the patient text images of the "torn skin" to the treatment provider showing a crescent-shaped small (3 mm wide x 10 mm long) full thickness burn at the rounded outer/lower corner of the return pad electrode surround by area of exposed dermis (15 mm high x 10 mm wide, including the crescent-shaped full thickness burn near the left side) and a blister (15 mm high x 20 mm wide) at the upper closest edge of the adjacent 40 cm2 handpiece electrode.The distance between the blister under the handpiece edge and the full thickness burn at the corner of the return was only approximately 15 mm.The patient went to an urgent care facility where she was prescribed bacitracin, potassium, and keflex to be taken for 10 days.Due to the location of the burn (bra line lateral right back), the patient had difficulty in caring for the wound herself leading to it becoming infected and bactrim being prescribed for 7 days.She is now receiving care from a dermatologist in addition to her primary care physician and the burn wounds are healing, but have not yet fully healed.The event is reportable due to the medical intervention required to treat the infection which developed in the burns.

• 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: 14895646
• Report Number: 2954354-2022-00004
• Device Sequence Number: 5150356
• Product Code: PBX
• UDI-Device Identifier: 00816722021427
• UDI-Public: 010081672202142711211222
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 07/01/2022

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: Other
• Device Model Number: TRUSCULPT ID
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2022
• Initial Report FDA Received Date: 07/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/23/2021
• 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; Required Intervention
• Patient Age: 37 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White