MAUDE Adverse Event Report: SOLTA MEDICAL INC. VASERLIPO; SYSTEM, SUCTION, LIPOPLASTY

Model Number	VASER PRO AMPLIFIER
Health Effect - Clinical Code	Full thickness (Third Degree) Burn (2696)
Date of Event	10/30/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
I am a plastic surgeon and on (b)(6) 2018 i had a case of a young lady who asked me to remove localize fat from the lateral part of the thighs and the lateral part of the abdomen.I used the vaserlipo device and the parameters that i used were the following: the wetting solution was of about 600ml for each side at the lateral thighs; at the same areas the probe of three rings; the settings were at 80%.I delivered energy for 5 mins and 43 seconds to the right side and 5 min to the left side.The energy was only delivered to the deep layer of the fat.Superficial layers were left untouched.No malfunction indication appeared on the vaser device.I did not do superficial lipolysis at all, i have followed all the guidelines that the company of the vaser suggests.After this treatment, no signs of any problem appeared and the pt has been discharged.A few days later, i saw that in the area a very severe burn was provoked.The burn was involving the whole thickness of the skin and fat as well, up to the underline muscles.It has happened to both areas of the lateral thighs and in a smaller grade at the lateral part of the abdomen.The burned area was extended to the limits and sometimes beyond the limits of the localized fat.If photos are needed, we are ready to provide them.The manufactured day of the device is july 14th 2017.After research, following the incident, we found that there has been a recall of some vaser devices [no.Of fda recall z-3047-2017 and z-3048-2017, (b)(4).

• Brand Name: VASERLIPO
• Common Device Name: SYSTEM, SUCTION, LIPOPLASTY
• Manufacturer (Section D): SOLTA MEDICAL INC. ; bothell WA 98011
• MDR Report Key: 8248911
• Report Number: MW5083101
• Device Sequence Number: 2279522
• Product Code: MUU
• UDI-Device Identifier: 00850608002537
• UDI-Public: (01)00850608002537(11)170714(21)
• Combination Product (Y/N): N
• Initial Reporter Country: GR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: VASER PRO AMPLIFIER
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/15/2019
• 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: Hospitalization; Required Intervention; Disability