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

Model Number	110-0021
Medical Device Problem Code	Key or Button Unresponsive/not Working (4063)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation is underway.
Event or Problem Description
A user facility reported the mode button was broken and would not toggle properly between modes during a vaserlipo procedure.This resulted in a delay of more than 60 minutes with the patient under general anesthesia.However, the procedure was able to be completed with another method.
Event or Problem Description
Additional information was received.The system was tested prior to use.The machine was switched on and all switches/buttons were checked and worked.However, during the procedure, the button's change mode did not function.The total time of the vaser delivery was about 8 minutes.The procedure was completed using suction from an anesthetic machine.
Additional Manufacturer Narrative
Field service confirmed the complaint of the mode button being broken.It is unknown what caused the broken button.Field service replaced the mode button and vaser cable.After the repair, the system passed functional and electrical safety tests.Delayed procedure due to inoperable handpiece and system is identified in vaserlipo system risk assessment.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 determined, and no conclusions can be drawn as to how the button was broken.The root cause of the delay was attributed to the broken button.At this time, no capa is necessary.

• 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: 19628681
• Report Number: 3011423170-2024-00179
• Device Sequence Number: 7146475
• Product Code: QPB
• UDI-Device Identifier: 00850608002483
• UDI-Public: 00850608002483
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2024

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: 110-0021
• 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: 06/10/2024
• Supplement Date Received by Manufacturer: 08/09/2024
• Initial Report FDA Received Date: 06/27/2024
• Supplement Report FDA Received Date: 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/11/2012
• 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