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

Model Number	820-FNBU2030LLNR
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product has been requested for evaluation.Investigation is underway.
Event or Problem Description
A user facility reported to a distributor that the ventx cannula separated from the base.The event occurred while the patient was under general anesthesia.As a direct consequence to the broken cannula, the procedure was delayed by approximately 60 minutes.The surgical intervention was ultimately completed using a replacement cannula.In accordance with internal safety guidelines, the case has been assessed as serious due to the extended duration of general anesthesia required as a direct consequence of the broken cannula.
Additional Manufacturer Narrative
Although attempts were made, no further information was provided by the customer and no product was returned for evaluation.Delay in procedure due to cannula breaking during a procedure is identified in the vaserlipo system risk assessment.The trend analysis, risk analysis and directions for use review are 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.At this time, no corrective action is necessary.

• Brand Name: VASERLIPO SYSTEM AND ACCESSORIES (CANNULA)
• Common Device Name: SYSTEM, SUCTION, LIPOPLASTY FOR REMOVAL
• Manufacturer (Section D): SOLTA MEDICAL, INC.; 11720 north creek pkwy n; suite 100; bothell WA 98011
• Manufacturer (Section G): SOLTA MEDICAL, INC.; 11720 north creek pkwy n; suite 100; bothell WA 98011
• Manufacturer Contact: sundeep jain ; 11720 north creek pkwy n; suite 100; bothell, WA 98011 ; 4254202135
• MDR Report Key: 22298079
• Report Number: 3011423170-2025-00283
• Device Sequence Number: 8562379
• Product Code: QPB
• UDI-Device Identifier: 00816995025733
• UDI-Public: 00816995025733
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• 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,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2025

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: 820-FNBU2030LLNR
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2025
• Supplement Date Received by Manufacturer: 07/07/2025
• Initial Report FDA Received Date: 06/20/2025
• Supplement Report FDA Received Date: 07/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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