MAUDE Adverse Event Report: CUTERA, INC TRUSCULPT; RADIO FREQUENCY INDUCED HEAT

Medical Device Problem Codes	Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017); Device Issue (2379); Human Factors Issue (2948)
Health Effect - Clinical Codes	Burn(s) (1757); Injury (2348); Patient Problem/Medical Problem (2688); Full thickness (Third Degree) Burn (2696)
Date of Event	05/31/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinic has not returned the handpiece.
Event or Problem Description
On june 17, 2016, (b)(6) reported to cutera that the patient developed a linear burn on the anterior neck (over the thyroid cartilage) while receiving a trusculpt treatment to the submentum area with the 40 cm trusculpt handpiece.(b)(6) sent photos of the anterior neck that showed an injury consistent with a thermal injury to the skin.(b)(6) reported that there are no malfunctions or failures associated with the trusculpt handpiece and they will not return the handpiece to cutera at this time.On june 23, 2016 (b)(6) retracted the report and stated the patient did not develop a burn from the trusculpt treatment but did not offer an alternative explanation for the injury.Burns are a known and expected side effect listed in the trusculpt instructions for use.The burn on the neck is not a life threatening injury or a serious deterioration in the patient's health but it does require professional medical management.The wound is in a cosmetically sensitive area and is high risk for scarring.This is the basis for reporting the incident to the fda.The clinic stopped responding to cutera's request for information about the event and has reported that the patient is "doing fine".The root cause of the incident is abnormal use by the device operator.Treating over the thyroid cartilage or trachea is foreseeable misuse.The trusculpt instructions for use and clinical training clearly advise the device operator that treatment of skin over the thyroid cartilage or trachea is contraindicated.The clinic reported that there are no malfunctions of failures associated with the trusculpt handpiece.Cutera has recommended that the device operator review all the clinical training and instructions for use for the submentum treatment.

• Brand Name: TRUSCULPT
• Common Device Name: RADIO FREQUENCY INDUCED HEAT
• Manufacturer (Section D): CUTERA, INC; 3240 bayshore blvd; brisbane CA 94005
• MDR Report Key: 5787228
• Report Number: 2954354-2016-00002
• Device Sequence Number: 1284327
• Product Code: PBX
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K122389
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Physician
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2016
• Initial Report FDA Received Date: 07/12/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 40 YR