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

Model Number	VHP
Medical Device Problem Codes	Break (1069); Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Field service will be evaluating the device.The investigation is ongoing.
Event or Problem Description
This report is related to 3011423170-2024-00130 (vaserlipo system) both involving the same patient.This report is associated with the vaser hand piece.A user facility reported that the vaser handpiece receptacle broke during a vaserlipo surgery.The treatment was aborted while the patient was under general anesthesia.An available video was received, and it demonstrates that the handpiece receptacle is damaged.Further information has been requested and the file will be updated accordingly.
Additional Manufacturer Narrative
The cannula and/or probe is a piece of metal used during the patient procedure.This piece of metal does not store any treatment data and thus there is no information to gather from its return.The exception to this would be if the cannula and/or probe had broken into pieces or was reported to have a burr that was involved in the patient injury.For other reported events, these items are not a viable source of evaluation data.The system has no system/data logs that can be reviewed.Field service visited the site and confirmed that the handpiece receptacle on the system was broken.Service replaced the receptacle and performed system functionality according to specifications.After repair, the system is fully functional.During the field service visit the handpiece was found to be damaged beyond repair.According to the vaserlipo safety risk assessment, damage to the vaser system can cause a delay in treatment.The lot history, trend analysis, risk analysis and directions for use review were considered acceptable, with the product performing within anticipated rates.It is unknown what caused the damage.At this time, no capa is necessary.
Additional Manufacturer Narrative
Both the product number and serial number of the device have been provided.The reported headpiece damage cannot be repaired in a manner that would allow the device to be returned to service.No nonconformities or anomalies were found related to this complaint when reviewing the device history record.The conclusions from the previous report submission remain unchanged.

• Brand Name: VASERLIPO HANDPIECE
• 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: 18886559
• Report Number: 3011423170-2024-00131
• Device Sequence Number: 7605008
• Product Code: QPB
• UDI-Device Identifier: 00850608002551
• UDI-Public: 00850608002551
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/12/2024

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; 07/24/2024
• Initial Report FDA Received Date: 03/12/2024
• Supplement Report FDA Received Date: 04/25/2024; 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/13/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: VASERLIPO SYSTEM SEE RELATED:3011423170-2024-00130.
• Patient Sex: Unknown