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

Model Number	VHP
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/30/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The user performed the vaser self test and it passed.However, the handpiece operational test did not pass.The handpiece is inoperable.The investigation is ongoing.
Event or Problem Description
A user facility reported that there was an issue with the vaser handpiece during surgery.The user was asked to perform the vaser self test and it passed.A new probe was connected and the operational vhp test was performed, and it worked in a recipient with water.However, when the user started again with the patient, it failed.The cable and connectors were inspected and the user confirmed they looked fine, but when asked them to stress the handpiece cable, it began failing and the connector seemed to disconnect easily from the console.As there was no backup handpiece available, the procedure was aborted.This resulted in the patient being under general anesthesia without clinical benefit, which may pose a risk of harm.Therefore, the event is considered a serious incident due to the unnecessary exposure to general anesthesia and the interruption of the planned procedure.
Additional Manufacturer Narrative
Correction: the information received originally from the reporter was incorrect.There was no delay of greater than 60 minutes with the patient under general anesthesia and the procedure was not aborted.As such, this event does not constitute a serious event and no longer meets reportability requirements.At the time of this report, no product has been received for evaluation and the root cause is unknown.No supplementary reports will be filed, as this event no longer meets reportability requirements.
Event or Problem Description
Updated information was received, and it is reported that the treatment was not aborted but was completed as a simple liposuction using another method.The malfunction caused a delay of less than 60 minutes.Therefore, the case was downgraded to not serious and no longer meets the reportability requirements.

• 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: 22145176
• Report Number: 3011423170-2025-00276
• Device Sequence Number: 8526502
• Product Code: QPB
• UDI-Device Identifier: 00850608002551
• UDI-Public: 00850608002551
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K190551
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2025

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2025
• Supplement Date Received by Manufacturer: 06/06/2025
• Initial Report FDA Received Date: 06/04/2025
• Supplement Report FDA Received Date: 06/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown