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

Model Number	VHP
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not been returned for an evaluation.The investigation is ongoing.
Event or Problem Description
A user facility reported that the the vaser stopped functioning in the middle of the surgery which resulted in an aborted procedure with the patient under general anesthesia more than 60 minutes.The physician tried wireless foot-pedals as well as a wired cable to no avail.The user facility also reported the handpiece was inoperable.The system was tested before the procedure.The treatment was carried out normally on the patient's torso, but when continuing onto the back, the handpiece stopped working.The total time of the vaser delivery was 20 minutes.The treatment was not able to completed with another system or different method.The procedure was canceled and the delay under general anesthesia was noted above 60 minutes; therefore, the case meets the reportability requirements and is deemed as a serious injury.
Additional Manufacturer Narrative
The customer confirmed the vaser device was working and passing self-tests.However, the handpiece was not returned for evaluation.Delayed procedure due to inoperable handpiece and system is identified in vaserlipo system risk assessment.Based on the available information, no causal factors can be determined, and no conclusions can be found.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 corrective action 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: 20364903
• Report Number: 3011423170-2024-00213
• Device Sequence Number: 6878557
• Product Code: QPB
• UDI-Device Identifier: 00850608002551
• UDI-Public: 00850608002551
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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): 09/18/2024

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: VHP
• 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: 09/18/2024
• Supplement Date Received by Manufacturer: 11/25/2024
• Initial Report FDA Received Date: 10/03/2024
• Supplement Report FDA Received Date: 12/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/02/2018
• 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