MAUDE Adverse Event Report: SOLTA MEDICAL, INC. LIPOSONIX SYSTEM MODEL 2; FOCUSED ULTRASOUND FOR TISSUE HEAT OR MECHANICAL

Model Number	P006373
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Swelling (2091); Superficial (First Degree) Burn (2685); Partial thickness (Second Degree) Burn (2694)
Date of Event	05/18/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The replaceable treatment cartridge (rtc) was returned and found to be deflated.The rtc was filled with fluid for testing.Rtc passed all testing performed.System event logs from the patient¿s treatment date were also provided.Logs show that 70 sites were treated at 60j fluence level using the rtc.Logs also show that during the treatment, three decoupling warnings occurred as well as two ¿cap low¿ warnings.These events pause treatment but do not require a system reset to continue treatment.Therefore, display of these system messages during treatment is unrelated to the event.System was operating within all normal parameters.A review of the device history records is in progress.
Event or Problem Description
A report received from taiwan stated that a patient who received liposonix treatment on (b)(6) 2018 reported to her treating physician on (b)(6) 2018 that she experienced burns, scabbing, and scratches on the back of her legs and buttocks post-procedure.No other treatments were being performed in the same area where the symptoms were reported and the patient had not undergone any other treatments in the same symptom-area within the past 30 days.Twenty minutes prior to the procedure on (b)(6) 2018 the patient took one arcoxia tablet prophylactically for pain relief.During the procedure, the physician made use of an iv with injected pethidine 50mg/1ml and dormicum 5mg/5ml for the patient.Physician reported that the patient indexed (scored) her pain during treatment at five to six.After the procedure, skin swelling and redness was noted.The patient was provided with a steroid ointment.Patient did not apply any heat, ice, or over-the-counter medications post-procedure.Burn classified in the 1st degree (superficial redness and swelling - specifically: surface swelling) and 2nd degree (blister, minor ¿ specifically: slight blisters appeared).Physician reported that the patient returned to the clinic on (b)(6) 2018 to undergo another liposonix treatment, this time for her inner thigh, lateral thigh, and inner knee.This treatment was completed without incident or abnormality.No adverse event experienced.It is reported that the patient is not currently experiencing any discomfort.The physician reported that they are waiting for the scabbing to fall off to treat the patient for the remaining pigmentation with nd-yag laser.Finally, physician reported that this patient has been successfully undergoing liposonix treatments for four years and that this is the first time they have experienced an event such as this.
Additional Manufacturer Narrative
A review of the device history records show that all requirements were met.Physician reported that during the procedure they encountered system code 2001, indicating surface depression within the replaceable treatment cartridge (rtc).After adding deionized water to the rtc, the treatment continued.A review of the system event logs showed that the system was operating within all normal parameters.System has software safeguards that will trigger error/event codes should the system be outside of acceptable limits.Review of the system/data logs does not indicate there was any handpiece or system issue present.According to liposonix safety risk assessment d002819, revision p and liposonix user manual p007253-03, revision a, possible side effects of treatment in targeted tissue include pain (discomfort), ecchymosis, erythema, superficial burn and edema, which are generally described (or rated) as mild.Based on all information, patient burns, redness, and swelling are known possible side effects of liposonix treatment.
Event or Problem Description
Additional information provided by the physician indicates that while the patient¿s treatment occurred on (b)(6)2018 and the patient reported symptoms to the physician on (b)(6)2018, the patient actually noticed the symptoms on (b)(6)2018.As previously reported, the patient is not currently experiencing any discomfort and has undergone additional liposonix treatments without incident.

• Brand Name: LIPOSONIX SYSTEM MODEL 2
• Common Device Name: FOCUSED ULTRASOUND FOR TISSUE HEAT OR MECHANICAL
• Manufacturer (Section D): SOLTA MEDICAL, INC.; 11720 north creek pkwy n; suite 100; bothell WA 98011
• MDR Report Key: 7610696
• Report Number: 3011423170-2018-00059
• Device Sequence Number: 16176622
• Product Code: OHV
• Combination Product (Y/N): Y
• Initial Reporter Country: TW
• PMA/510(K) Number: K112626
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2018

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: P006373
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2018
• Initial Date Received by Manufacturer: 05/19/2018
• Supplement Date Received by Manufacturer: 05/19/2018
• Initial Report FDA Received Date: 06/18/2018
• Supplement Report FDA Received Date: 07/13/2018
• 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: 35 YR