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

Model Number	TRUSCULPT ID 16CM^2 HANDPIECE
Medical Device Problem Codes	Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017); Detachment of Device or Device Component (2907); Excessive Heating (4030)
Health Effect - Clinical Code	Partial thickness (Second Degree) Burn (2694)
Date of Event	12/05/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The detachable handpiece is in transit to the manufacturer and has not been received on 1/2/2019.
Event or Problem Description
Detachable handpiece temperature sensor malfunction during energy delivery.The handpiece is pending return for further testing and root cause analysis.Adult, female experienced a partial thickness burn requiring professional medical management.
Event or Problem Description
The trusculpt id was returned to cutera for comprehensive inspection and testing.The trusculpt id console behaved as intended, was not defective, and did not malfunction in any way.

• Brand Name: TRUSCULPT ID
• Common Device Name: MASSAGER, VACUUM, RADIO FREQUENCY INDUCED HEAT
• Manufacturer (Section D): CUTERA, INC; 3240 bayshore blvd; brisbane CA 94005
• MDR Report Key: 8210985
• Report Number: 2954354-2018-00002
• Device Sequence Number: 16673829
• Product Code: PBX
• UDI-Device Identifier: 00816722022448
• UDI-Public: 010081672202244811180928
• Combination Product (Y/N): N
• Initial Reporter Country: LE
• PMA/510(K) Number: K180709
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2018

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: No Information
• Device Model Number: TRUSCULPT ID 16CM^2 HANDPIECE
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/05/2018
• Supplement Date Received by Manufacturer: 12/05/2018
• Initial Report FDA Received Date: 01/02/2019
• Supplement Report FDA Received Date: 04/19/2019
• 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