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

Model Number	110-0022
Medical Device Problem Codes	Decrease in Suction (1146); Battery Problem (2885); Communication or Transmission Problem (2896); Noise, Audible (3273)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A user facility reported that the foot pedals stopped working during a vaserlipo procedure, which resulted in a delay of more than 60 minutes with the patient under general anesthesia.The batteries were replaced and one of the two footpedals (blue) began working.The customer then attached the wired footpedal to the vaser.The customer was having difficulty pairing the footpedals but eventually they were able to pair them and completed the surgery.
Additional Manufacturer Narrative
The customer was having difficulty pairing the footpedals but eventually they were able to pair them and completed the surgery.The customer declined to have the footpedal returned for evaluation.Delayed procedure due to inoperable foot pedal/switch is identified in vaserlipo system risk assessment.Based on the available information, no causal factors can be determined and no conclusions can be found.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.
Additional Manufacturer Narrative
Field service visited the site for evaluation.While onsite, they confirmed one wireless footswitch was functional, and the second couldn't be tested due to dead batteries.Field service could not confirm customer's report of noise or issues with the suction pump.The system tested within specifications.The system is working as intended.As a precaution, service will replace the pump.The conclusions from the previous report remain unchanged.
Event or Problem Description
Additional information was received regarding the events that occurred during the vaserlipo surgery.The user facility also reported zero suction with the vacuum pump.Prior to treatment, an off-grinding and clicking noise was coming from bottom of the ventx console.No pal (power assisted lipo) device was used.

• Brand Name: VASERLIPO SYSTEM AND ACCESSORIES
• Common Device Name: SYSTEM, SUCTION, LIPOPLASTY
• 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: 19713554
• Report Number: 3011423170-2024-00184
• Device Sequence Number: 8777845
• Product Code: QPB
• UDI-Device Identifier: 00850608002490
• UDI-Public: 00850608002490
• 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: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2024

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?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/21/2024
• Supplement Date Received by Manufacturer: 07/10/2024
• Initial Report FDA Received Date: 07/10/2024
• Supplement Report FDA Received Date: 08/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/01/2022
• 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