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

Model Number	110-0037
Medical Device Problem Codes	No Display/Image (1183); Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has been requested.The investigation is underway.
Event or Problem Description
A user facility reported that the vaserlipo system display screen was black.However, the user could hear that the system turned on.This occurred while the patient was under general anesthesia for over 60 minutes and resulted in the procedure being aborted.Since the procedure was canceled and the delay under general anesthesia was noted above 60 minutes, the case meets the reportability requirements and is deemed as a serious incident.
Additional Manufacturer Narrative
Field service confirmed the issue.It was found that the system had loose wires on the speaker board.Service tightened the wires in their correct position and performed a complete functional verification per specifications.Delayed procedure due to no display is identified in vaserlipo system risk assessment.No nonconformities or anomalies were found related to this complaint when reviewing the device history record.The lot history, trend analysis, risk analysis and directions for use review were considered acceptable, with the product performing within anticipated rates.Based on the available information, this issue was caused by loose wires on the speaker board.At this time, no capa is necessary.

• Brand Name: VASERLIPO SYSTEM
• 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: 21094131
• Report Number: 3011423170-2025-00239
• Device Sequence Number: 8664917
• Product Code: QPB
• UDI-Device Identifier: 00850608002537
• UDI-Public: 00850608002537
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/10/2024

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: 110-0037
• 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: 12/10/2024
• Supplement Date Received by Manufacturer: 04/09/2025
• Initial Report FDA Received Date: 01/07/2025
• Supplement Report FDA Received Date: 05/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/22/2023
• 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