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

Model Number	110-0022
Medical Device Problem Codes	Pumping Stopped (1503); Suction Failure (4039)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Field service evaluated the device and no fault was found as service could not replicate issue.The client was advised to monitor the device and to power down the machine for about a minute before powering it back up to make sure the system completely powers down and settles.The device may have been hung up due to multiple power failures.According to the vaserlipo safety risk assessment, insufficient suction or pump 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.Based on the available information, no causal factors can be found, and no conclusion can be drawn.At this time, a capa is not necessary.
Event or Problem Description
A user facility reported that the during a vaserlipo procedure, the pump would not turn on in the middle of the procedure, and thus there was no suction.The patient was under general anesthesia and the surgeon had to abort the procedure since the pump stopped working.No other equipment was used.The customer had been using the ventx throughout the procedure.They stopped using the ventx for a while and when they attempted to use it again the pump was not turning on.They only heard the click when turning on the ventx.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 with the patient under general anesthesia.

• 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 north creek pkwy n; ste 100; bothell WA 98011
• Manufacturer Contact: sundeep jain ; 11720 n creek pkwy n; ste 100; bothell, WA 98011 ; 4254202135
• MDR Report Key: 19128077
• Report Number: 3011423170-2024-00146
• Device Sequence Number: 12823982
• Product Code: QPB
• UDI-Device Identifier: 00850608002490
• UDI-Public: 00850608002490
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 03/21/2024

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/25/2023
• 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