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

Model Number	110-0032
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A field service evaluation did not identify any device issues.The self-test passed, and the reported problem was not duplicated.Upon customer request, the field service technician returned for further device evaluation and again did not detect any system concerns.The self-test passed, and the reported problem was not duplicated.The handpiece was tested for ten minutes in water and no issues were found.As a precaution and request from the customer, field service replaced the ultrasound board.The self-test was again performed, and the handpiece was tested again in water for five minutes, with passing results.Field service product evaluation did not confirm the failure mode.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.Final test verification specifications are acceptable.No nonconformities or anomalies were found related to this event when reviewing the device history record.The lot history, trend analysis, risk analysis and directions for use review are considered acceptable, with the product performing within anticipated rates.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.No corrective action is necessary at this time.
Event or Problem Description
It was reported that during a vaser lipo procedure a patient experienced a procedure delay of greater than sixty minutes while under general anesthesia due to a system self-test failure.The vaser system was inoperable with a red triangle error signal during the treatment, which was a surgery on back, flanks, arms, and submentum.A ventx and microaire pal (power assisted lipo) were used during the procedure.No patient injury occurred; however, the event is considered a serious injury per solta procedure due to the procedure delay over 60 minutes while the patient was under general anesthesia.The procedure was successfully completed using another vaser lipo device from a different clinic nearby.

• Brand Name: VASERLIPO SYSTEM AND ACCESSORIES
• 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: 20128708
• Report Number: 3011423170-2024-00206
• Device Sequence Number: 3265536
• Product Code: QPB
• UDI-Device Identifier: 00850608002506
• UDI-Public: 00850608002506
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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: User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 08/07/2024

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: 110-0032
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2024
• Initial Report FDA Received Date: 09/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/07/2023
• 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