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

Model Number	110-0037
Medical Device Problem Codes	Break (1069); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/07/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A user facility reported that the foot pedal of their vaser system did not work upon preparation for a treatment.The vaser foot pedal was physically damaged.There was a delay of more than sixty minutes with the patient under general anesthesia and 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, as the footswitch is not manufactured by solta.Therefore, no further evaluation can be performed.A delay in a procedure due to an inoperable foot pedal/switch is identified in the vaserlipo system risk assessment.No nonconformities or anomalies were found related to this complaint when reviewing the device history record for the vaser system.The trend analysis, risk analysis, and directions for use review were considered acceptable, with the product performing within anticipated rates.Based on the available information, no causal factors can be determined, and no conclusions can be found.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 n creek pkwy n; ste 100; bothell WA 14609
• 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: 21587680
• Report Number: 3011423170-2025-00254
• Device Sequence Number: 8868127
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/09/2025

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: 110-0037
• 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: 02/11/2025
• Initial Report FDA Received Date: 03/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/17/2024
• 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