VASERLIPO SYSTEM
Report
- Report Number
- 3011423170-2023-00018
- Event Type
- Injury
- Date Received
- February 8, 2023
- Date of Event
- January 10, 2023
- Report Date
- January 12, 2023
- Manufacturer
- SOLTA MEDICAL INC
- Product Code
- QPB
- PMA / PMN Number
- K190551
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
THE PRODUCT HAS BEEN RETURNED AND THE EVALUATION IS ANTICIPATED SHORTLY. A REVIEW OF MANUFACTURING RECORDS SHOW THE FINAL MANUFACTURING TEST VERIFICATION SPECIFICATIONS ARE ACCEPTABLE. NO NON-CONFORMITIES OR ANOMALIES FOUND RELATED TO THIS COMPLAINT WHEN REVIEWING THE DEVICE HISTORY RECORD. THE INVESTIGATION IS ONGOING.
CORRECTION: B3: DATE OF EVENT FROM 09-JAN-2023 TO 10-JAN-2023. THE VASERLIPO SYSTEM WAS RETURNED FOR EVALUATION AND SERVICE WAS UNABLE TO CONFIRM ANY FUNCTIONAL ISSUE WITH THE UNIT. THE SYSTEM POWERED ON AND PASSED IT''S SELF-TESTS. THE POWER, CURRENT, VOLTAGE AND FREQUENCY OUTPUTS WERE ALL WITHIN SPECIFIED PARAMETERS. THE SAFE AND EFFECTIVE USE OF THIS MEDICAL DEVICE DEPENDS ON A LARGE DEGREE ON FACTORS SOLELY UNDER THE CONTROL OF THE OPERATOR. IT IS IMPORTANT THAT ALL OPERATORS OF THE VASERLIPO SYSTEM READ, UNDERSTAND, AND FOLLOW THE OPERATING INSTRUCTIONS SUPPLIED WITH EQUIPMENT. USE OF THIS DEVICE IS LIMITED TO THOSE PHYSICIANS WHO, BY MEANS OF FORMAL PROFESSIONAL TRAINING OR SANCTIONED CONTINUING MEDICAL EDUCATION (INCLUDING SUPERVISED OPERATIVE EXPERIENCE), HAVE ATTAINED PROFICIENCY IN SUCTION LIPOPLASTY. A REVIEW OF THE MANUFACTURING RECORDS SHOWED ALL REQUIREMENTS WERE MET. THE LOT HISTORY, TREND ANALYSIS, RISK ANALYSIS AND/OR 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 NON-CONFORMITIES OR ANOMALIES FOUND RELATED TO THIS COMPLAINT WHEN REVIEWING THE DEVICE HISTORY RECORD FOR THE SERIAL/LOT NUMBER. BASED ON THE AVAILABLE INFORMATION, NO CAUSAL FACTORS CAN BE DETERMINED AND NO CONCLUSIONS CAN BE DRAWN. THIS EVENT WAS MOST LIKELY UNRELATED TO THE VASER DEVICE. NO CORRECTIVE ACTION IS REQUIRED.
THE PRODUCT HAS BEEN REQUESTED TO BE RETURNED FOR EVALUATION. THE INVESTIGATION IS ONGOING.
ADDITIONAL INFORMATION WAS PROVIDED FOR THE PATIENT EVENT. THE PATIENT HAD RECEIVED VASER TREATMENT IN THEIR UPPER AND LOWER BACK AREAS, WAIST AND BILATERAL UPPER EXTREMITY. THE DAY FOLLOWING THE PROCEDURE THE PATIENT OBSERVED A BURN IN THE LEFT POSTERIOR UPPER EXTREMITY AREA. THE PATIENT WAS GIVEN COPPER PEPTIDE CREAM AND ADVISED TO MONITOR THE INJURY. THE CURRENT STATUS IS REPORTED AS STABLE. AVAILABLE PICTURES OF THE INJURY WERE REVIEWED AND THERE WAS CRUST AND POST INFLAMMATORY HYPERPIGMENTED AREAS VISIBLE ON ONE SIDE OF THE UPPER ARM. A SECOND PICTURE, NOT AS CLEAR, SHOWED A LARGE CRUST IN LIKELY THE FLANK AREA. TOTAL VASER TIME WAS 1 MINUTE IN EACH ARM WITH THE HIGHEST AMPLITUDE OF 60% IN VASER MODE, AND 700CC OF TUMESCENT FLUID WAS ADMINISTERED. A SKIN PORT WAS USED DURING THE PROCEDURE ALONG WITH A TOWEL BARRIER TO PROTECT THE SKIN FROM PROBE CONTACT. THE PATIENT RECEIVED STANDARD LIPOSUCTION IN THE SAME SYMPTOM AREA ON THE PROCEDURE DATE BUT HAD NO OTHER PROCEDURES WITHIN 30 DAYS PRIOR. THE SYSTEM WAS NOT TESTED PRIOR TO THE PROCEDURE AND NO SYSTEM ISSUE WERE PRESENT. THE PROCEDURE WAS COMPLETED USING THE VASER SYSTEM.
A USER FACILITY REPORTED TO A SOLTA SERVICE REPRESENTATIVE THAT A PATIENT EXPERIENCED A BURN DURING A VASER PROCEDURE. NO FURTHER DETAILS OF THE EVENT WERE PROVIDED AND THE PATIENT''S CURRENT STATUS IS UNKNOWN. ADDITIONAL INFORMATION IS BEING SOUGHT AFTER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2229190 | VASERLIPO SYSTEM | SYSTEM, SUCTION, LIPOPLASTY | QPB | SOLTA MEDICAL INC | 110-0032 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 45 YR | Female | Required Intervention |