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

Model Number	110-0022
Medical Device Problem Code	Suction Problem (2170)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Field service confirmed the suction pump was non-operational.The suction pump was replaced.After repair, the system passed irrigation pump operation verification, chassis ground resistance, suction pump operation verification and functionality.The system performed as expected.According to the vaserlipo safety risk assessment, insufficient suction issues can cause delay in treatment.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.
Event or Problem Description
A user facility reported that their ventx did not have suction during a procedure while the patient was general anesthesia.As a result, the surgery was cancelled, and the patient was awakened after 5 minutes of troubleshooting.This event was assessed as serious due to the aborted procedure while the patient was 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: 22022720
• Report Number: 3011423170-2025-00270
• Device Sequence Number: 9114391
• Product Code: QPB
• UDI-Device Identifier: 00850608002490
• UDI-Public: 00850608002490
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/15/2025

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: 110-0022
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2025
• Initial Report FDA Received Date: 05/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/28/2016
• 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