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 Failure (4039)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Solta requested pictures of the device tubing, but the provided pictures were insufficient to determine if contamination was present during the procedure.More detailed photos were requested but were not provided.The customer notified solta that they are declining a solta repair and that they have repaired the device as the motor was stuck.Upon requesting additional information, the provider stated that their biomedical department removed the motor and saw dust collection causing the motor to get stuck.Upon cleaning out and reinstalling the motor, the unit functioned normally.As the provider has declined additional device evaluation or repair, no further device information is available.The investigation is underway.
Event or Problem Description
A user facility reported a clicking sound when activating the suction on the vaserlipo system, but the pump would not run.This resulted in a delay of more than sixty minutes with the patient under general anesthesia.The procedure was ultimately aborted.Both the delay of over sixty minutes while the patient is under general anesthesia and the procedure being aborted are considered serious incidents per solta procedure.
Additional Manufacturer Narrative
No product was returned for evaluation, as the provider reported that they repaired the system themselves by removing and cleaning the pump.The return for further evaluation or repair was declined.According to the vaserlipo system risk assessment, a delayed procedure due to inoperable suction is identified, and the user manual provides users with cleaning guidance on cleaning the console and footswitches.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, the pump issues were resolved by cleaning the pump.No corrective action is necessary at this time.

• Brand Name: VASERLIPO SYSTEM AND ACCESSORIES
• Common Device Name: SYSTEM, SUCTION, LIPOPLASTY FOR REMOVAL
• Manufacturer (Section D): SOLTA MEDICAL, INC; 11720 n creek pkwy n; ste 100; bothell WA 98011
• Manufacturer (Section G): SOLTA MEDICAL, INC; 11720 n creek pkwy n; suite 100; bothell WA 98011
• Manufacturer Contact: sundeep jain ; 11720 n creek pkwy n; ste. 100; bothell, WA 98011 ; 4254202135
• MDR Report Key: 21200945
• Report Number: 3011423170-2025-00244
• Device Sequence Number: 7475862
• Product Code: QPB
• UDI-Device Identifier: 00850608002490
• UDI-Public: 00850608002490
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/20/2024

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: 110-0022
• 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: 12/24/2024
• Supplement Date Received by Manufacturer: 02/06/2025
• Initial Report FDA Received Date: 01/21/2025
• Supplement Report FDA Received Date: 03/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/16/2017
• 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