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

Model Number	110-0036
Medical Device Problem Codes	Suction Problem (2170); Noise, Audible (3273); Key or Button Unresponsive/not Working (4063)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A video of a surgery was sent into service, and it was confirmed that the pump is beginning to fail.The investigation is ongoing.
Event or Problem Description
A user facility reported to the distributer that the button to select the suction mode (s) did not start after pressing it.It only started after about 15 minutes and was making an unusual noise.The suction was disconnected and the moment it was turned back on, time was lost again for it to start.The treatment was able to be completed using another device.This caused a delay of 60 minutes or greater for the length of time the patient was under general anesthesia.In accordance with internal guidelines, the event was assessed as a serious incident and deemed reportable due to the significant prolongation of the procedure (greater than 60 minutes), which may increase risk to the patient under general anesthesia.
Additional Manufacturer Narrative
The occlusion test was performed with the customer and the issue could not duplicated.The vacuum was working as designed.It was suspected the mode selection button could start to fail.It was later determined from a video of the issue, that the pump is beginning to fail and needs to be replaced.However, the customer declined a visit by the field service engineer.As a result, the issue could not be confirmed.Delayed procedure due to inoperable suction or suction button issues are identified in vaserlipo system risk assessment.Based on the available information, no causal factors can be determined and no conclusions can be drawn.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.At this time, no capa is necessary.

• 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: 22109754
• Report Number: 3011423170-2025-00274
• Device Sequence Number: 12581839
• Product Code: QPB
• UDI-Device Identifier: 00850608002520
• UDI-Public: 00850608002520
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 03/13/2025

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: 110-0036
• 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: 05/02/2025
• Supplement Date Received by Manufacturer: 07/06/2025
• Initial Report FDA Received Date: 05/29/2025
• Supplement Report FDA Received Date: 07/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/13/2020
• 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