MAUDE Adverse Event Report: SOLTA MEDICAL, INC. VASERLIPO SYSTEM AND ACCESSORIES; SYSTEM, SUCTION, LIPOPLASTY FOR REMOVAL

Model Number	VHP
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/03/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No product was returned for evaluation.The customer was advised the handpiece is not repairable.No patient injury occurred but the treatment was delayed greater than 60 minutes while the patient was under general anesthesia.This event meets the definition of a serious injury per the solta medical reviewer due to the prolonged procedure.Delayed procedure due to an inoperable handpiece and system is identified in the vaserlipo system risk assessment.A review of the manufacturing records showed all requirements were met.The lot history, trend analysis, risk analysis and directions for use review were considered acceptable, with the product performing within anticipated rates.Review of manufacturing records show final manufacturing test verification specifications are acceptable.No nonconformities or anomalies were found related to this event when reviewing the device history record.Based on the available information, no causal factors can be determined, and no conclusions can be found.No corrective action is necessary at this time.
Event or Problem Description
A user facility contacted solta during a vaserlipo procedure and reported that the wireless footswitch stopped communicating to the vaser and they were unable to deliver ultrasound energy.The customer had changed the batteries in the wireless footswitch and tried to use a wired footswitch connected directly to the amplifier, however they were unable to get the vaser amplifier to deliver energy.Through further troubleshooting, solta found the vaser was not responding due to the vaser handpiece.The customer did not have an additional handpiece to use.This issue caused a delay longer than 60 minutes with the patient under general anesthesia.The surgery was completed without use of the vaser amplifier.Solta has made attempts to obtain further information about the event, but they have been unsuccessful and it appears no response will be forthcoming.There were no health consequences to the patient, however, this event meets the definition of a serious injury per solta medical reviewer due to the prolonged procedure greater than one hour while under general anesthesia.

• Brand Name: VASERLIPO SYSTEM AND ACCESSORIES
• Common Device Name: SYSTEM, SUCTION, LIPOPLASTY FOR REMOVAL
• Manufacturer (Section D): SOLTA MEDICAL, INC.; 11720 north creek pkwy n; suite 100; bothell WA 98011
• Manufacturer (Section G): SOLTA MEDICAL, INC.; 11720 north creek pkwy n; suite 100; bothell WA 98011
• Manufacturer Contact: sundeep jain ; 11720 north creek pkwy n; suite 100; bothell, WA 98011 ; 4254202135
• MDR Report Key: 21944969
• Report Number: 3011423170-2025-00267
• Device Sequence Number: 15549097
• Product Code: QPB
• UDI-Device Identifier: 00850608002551
• UDI-Public: 00850608002551
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K190551
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/03/2025

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: VHP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2025
• Initial Report FDA Received Date: 05/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/08/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown