MAUDE Adverse Event Report: SOLTA MEDICAL INC. VASERLIPO SYSTEM; SYSTEM, SUCTION, LIPOPLASTY

Model Number	110-0037
Medical Device Problem Codes	Material Fragmentation (1261); Blocked Connection (2888)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Correction section h6: initial mdr showed code 2199 under health effect clinical code 2 when it should have been under health effect impact code 3.According to the vaserlipo safety risk assessment damage to the vaser system and handpiece can cause a delay in treatment.A review of the manufacturing records showed all requirements were met.The lot history, trend analysis, risk analysis and directions for use review were considered acceptable, with the product performing within anticipated rates.Review of manufacturing records show final manufacturing test verification specifications are acceptable.No nonconformities or anomalies were found related to this event when reviewing the device history record.Based on available information, the issue was caused by the user physically damaging the handpiece cable during treatment by pulling on it, which left pins from the handpiece inside the handpiece receptacle on the vaser system.No corrective action is necessary at this time.
Additional Manufacturer Narrative
Field service evaluated the system and confirmed there were handpiece pins stuck inside the handpiece connector port.Service replaced the handpiece connection port and after repairs the system performed as expected.The investigation is ongoing.
Event or Problem Description
This case is related to report number: 3011423170-2024-00219.Both cases are the same patient/event and corresponds to the vaser handpiece.A user facility reported that they had pulled the handpiece cable during surgery and the vaser handpiece pins broke off the handpiece connector and got stuck inside the vaser amplifier handpiece connection port.The customer was unable to connect another vaser handpiece due to the stuck pins.The customer reportedly did not have to abort the procedure and used conventional liposuction to finish the surgery.The patient was under general anesthesia when the issue occurred, which resulted in a delay greater than 60 minutes.Further information has been requested however the customer did not provide any further details of the event.There were no reported health consequences to the patient, however, this event meets the definition of a serious injury per solta medical reviewer due to the delay while under general anesthesia.

• Brand Name: VASERLIPO SYSTEM
• Common Device Name: SYSTEM, SUCTION, LIPOPLASTY
• Manufacturer (Section D): SOLTA MEDICAL INC.; 11720 n creek pkwy n; suite 100; bothell WA 98011
• Manufacturer (Section G): SOLTA MEDICAL INC.; 11720 n creek pkwy n; suite 100; bothell WA 98011
• Manufacturer Contact: sundeep jain ; 11720 n creek pkwy n; suite 100; bothell, WA 98011 ; 4254202135
• MDR Report Key: 20631719
• Report Number: 3011423170-2024-00218
• Device Sequence Number: 8144000
• Product Code: QPB
• UDI-Device Identifier: 00850608002537
• UDI-Public: 00850608002537
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 10/08/2024

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: 110-0037
• 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: 10/09/2024
• Supplement Date Received by Manufacturer: 11/27/2024
• Initial Report FDA Received Date: 11/07/2024
• Supplement Report FDA Received Date: 12/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/08/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown