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

Model Number	VHP
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A user facility reported that their vaser handpiece was not working while connected to the vaser and the alarm of the device was on.The patient was under general anesthesia when the issue occurred, and the treatment had to be canceled.The vaser system and handpieces were used that day for a previous procedure with no issue noted.
Additional Manufacturer Narrative
The field service engineer performed the vaser self-test with the user, and it was successful.The user confirmed that the vaser smooth handpiece (a separate handpiece) and connector of the vaser handpiece was working and that the cable was not damaged.The investigation is ongoing.
Additional Manufacturer Narrative
No product was returned for evaluation.The customer was able to perform a successful self-test with the handpiece.The customer reported the handpiece was working and the connector of the vaser handpiece as well.A delayed procedure due to an 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 found.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: 19512710
• Report Number: 3011423170-2024-00169
• Device Sequence Number: 7489191
• Product Code: QPB
• UDI-Device Identifier: 00850608002551
• UDI-Public: 00850608002551
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2024

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2024
• Supplement Date Received by Manufacturer: 10/09/2024
• Initial Report FDA Received Date: 06/11/2024
• Supplement Report FDA Received Date: 10/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/29/2018
• 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