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

Model Number 110-0022

Device Problems Pumping Stopped (1503); Suction Problem (2170)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/13/2022

Event Type  Injury  

Manufacturer Narrative

Field service evaluated the device and determined that the issue was not because of the vacuum pump, but because of the power relay part.The plant evaluation is underway.

Event Description

A user facility reported an issue with the ventx suction pump that resulted in a delay in treatment, while the patient was under general anesthesia.No other information is available but is being sought after.The file will be updated accordingly.

Manufacturer Narrative

Field service was able confirm the issue.It was determined that the issue was due to a power relay part.The pump stopped working after the initial startup.According to the vaserlipo safety risk assessment, insufficient suction issues can cause a delay in the treatment.The lot history, trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.Final test verification specifications are acceptable.No non-conformities or anomalies found related to this complaint when reviewing the device history record.No corrective action is required.

• Brand Name: VASERLIPO SYSTEM
• Type of Device: 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 n 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: 15761103
• MDR Text Key: 303335130
• Report Number: 3011423170-2022-00141
• Device Sequence Number: 1
• Product Code: MUU
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110306
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 110-0022
• Device Catalogue Number: 110-0022
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/14/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1