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

Model Number	110-0032
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Further information and device evaluation has been requested.The investigation is ongoing.
Event or Problem Description
A user facility reported that they were unable to complete a vaser procedure on a patient because the vaser footswitch stopped working.There was a delay of greater than 60 minutes while the patient was under general anesthesia.The vaser delivery on the front of the patient was completed but the procedure had to be aborted prior to completion of the vaser procedure on the patient¿s back.There were no health consequences to the patient, however, this event meets the definition of a serious injury per solta medical reviewer due to the aborted procedure as well as the greater than one hour delay while under general anesthesia.
Additional Manufacturer Narrative
Solta made multiple attempts to obtain further information about the event but were unsuccessful, and it appears no response will be forthcoming.No product was returned for evaluation.The system does not have any system data logs or event data logs that can be reviewed.Delayed procedure due to an inoperable footswitch is identified in the vaserlipo system risk assessment.A review of the manufacturing records showed all requirements were met.The lot history, trend analysis, risk analysis and directions for use review were considered acceptable, with the product performing within anticipated rates.Review of manufacturing records show final manufacturing test verification specifications are acceptable.No nonconformities or anomalies were found related to this event when reviewing the device history record.Based on the available information, no causal factors can be determined and no conclusions can be found.No corrective action is necessary at this time.

• Brand Name: VASERLIPO SYSTEM
• Common Device Name: SYSTEM, SUCTION, LIPOPLASTY
• Manufacturer (Section D): SOLTA MEDICAL INC.; 11720 n creek pkwy n; suite 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; suite 100; bothell, WA 98011 ; 4254202135
• MDR Report Key: 19082942
• Report Number: 3011423170-2024-00141
• Device Sequence Number: 18072999
• Product Code: QPB
• UDI-Device Identifier: 00850608002506
• UDI-Public: 00850608002506
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Followup
• Report Date (Section B): 03/15/2024

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
• Device Model Number: 110-0032
• 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: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/10/2024
• Supplement Report FDA Received Date: 05/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/02/2020
• 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