MAUDE Adverse Event Report: SYNERON MEDICAL LTD. YOKNEAM, ILLIT, ISRAEL ULTRASHAPE POWER; ULTRASOUND BODY CONTOURING DEVICE

Model Number	FG71481US
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Partial thickness (Second Degree) Burn (2694)
Date of Event	04/18/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An evaluation of the ultrashape power system was performed at the customer site by a syneron-candela field technician on 5-2-2018, including functional testing of the four transducers at the site.All systems met functional specifications and no discrepancies were identified.In addition, syneron-candela service technicians evaluated the returned velashape iii system on 5-2-2018 and the two applicators used in the procedure on (b)(6) 2018.The evaluation revealed no observed system issues and the applicators were all within specification.Although a definitive root cause could not be determined in this case, causes that may lead to burns and blisters include: dirty/contaminated transducers.Treatment of fat thickness less than specified in the user manual.Insufficient ultrasound gel on treatment area.Not using a level treatment plane.Skin surface factors such as hair, body jewelry, bubbles in ultrasound gel, presence of other skin products on treatment area.The root cause of this event is unknown.
Event or Problem Description
Female patient, (b)(6) with skin type iii, underwent combined treatment on (b)(6) 2018 and reported burn on inner thigh area.

• Brand Name: ULTRASHAPE POWER
• Common Device Name: ULTRASOUND BODY CONTOURING DEVICE
• Manufacturer (Section D): SYNERON MEDICAL LTD. YOKNEAM, ILLIT, ISRAEL; syneron medical ltd.; yokneam illit, ; IS
• MDR Report Key: 7544800
• Report Number: 3003772750-2018-00002
• Device Sequence Number: 178107
• Product Code: OHV
• UDI-Device Identifier: 07290109950990
• UDI-Public: 07290109950990
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K160896
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/25/2018

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: Health Professional
• Device Model Number: FG71481US
• Device Catalogue Number: FG71481US
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/27/2018
• Initial Report FDA Received Date: 05/25/2018
• 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: Other
• Patient Age: 33 YR