MAUDE Adverse Event Report: SOUND SURGICAL TECHNOLOGIES LLC THE VASER SYSTEM VENTX-1; SUCTION PUMP

Model Number VENTX-1

Device Problems Failure to Power Up (1476); Suction Problem (2170)

Patient Problem No Patient Involvement (2645)

Event Date 12/16/2015

Event Type  Injury  

Event Description

After injection of tumescent and cannulation of the bilateral upper backs, the procedure was aborted due to the inability to perform liposuction within the time period where the tumescent fluid would be effective.

• Brand Name: THE VASER SYSTEM VENTX-1
• Type of Device: SUCTION PUMP
• Manufacturer (Section D): SOUND SURGICAL TECHNOLOGIES LLC; 357 so. mcaslin blvd suite #100; louisville CO 80027 2932
• MDR Report Key: 5508047
• MDR Text Key: 40745620
• Report Number: 5508047
• Device Sequence Number: 1
• Product Code: MUU
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/23/2016
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: VENTX-1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/23/2016
• Distributor Facility Aware Date: 12/16/2015
• Device Age: NA
• Event Location: Hospital
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 55 YR
• Patient Weight: 56