VASERLIPO SYSTEM
Report
- Report Number
- 3011423170-2023-00001
- Event Type
- Injury
- Date Received
- January 5, 2023
- Date of Event
- December 7, 2022
- Report Date
- December 12, 2022
- Manufacturer
- SOLTA MEDICAL, INC
- Product Code
- QPB
- PMA / PMN Number
- K190551
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PO
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
THE DEVICE HAS BEEN REQUESTED. THE INVESTIGATION IS ONGOING.
CORRECTION: CORRECTION: SECTION D1 - FROM: VASER PRO AMPLIFIER - TO: VASERLIPO SYSTEM. SECTION D2: FROM: ULTRASONIC SURGICAL SYSTEM GENERATOR - TO: SYSTEM, SUCTION, LIPOPLASTY. PRODUCT CODE FROM: MUU - TO: QPB. SECTION G4: FROM: K110306 - TO: K190551. THE CUSTOMER HAS BEEN ADVISED TO STOP USING THE DEVICE. FINAL TEST VERIFICATION SPECIFICATIONS ARE ACCEPTABLE. NO NON-CONFORMITIES OR ANOMALIES FOUND RELATED TO THIS COMPLAINT WHEN REVIEWING THE DEVICE HISTORY RECORD. ATTEMPTS ARE BEING MADE TO GET THE DEVICE BACK FOR EVALUATION. IF THE DEVICE SHOULD BE RETURNED AND EVALUATED, A SUPPLEMENTAL REPORT WILL BE FILED.
CORRECTION: B3: DATE OF EVENT - FROM 05DEC2022 TO 07DEC2022. TREATMENT SETTINGS WERE APPROPRIATE. IT WAS REPORTED LOW AMPLITUDE POWER WAS USED. THE AMOUNT OF VASER TIME WAS NORMAL FOR THE PROCEDURE. A LARGE AND SAFE AMOUNT OF WETTING SOLUTION WAS INFILTRATED. THE DEVICE AND HANDPIECES WERE RETURNED FOR EVALUATION. VASER AMPLIFIERS ARE EQUIPPED WITH AUDIBLE AND VISUAL INDICATORS (ALERT/WARNING) FOR SYSTEM FAULT CONDITIONS. THE AUDIBLE ALERT/WARNING SIGNAL INDICATOR IS AN URGENT WARNING TONE WHICH CAN OCCUR IF THE SYSTEM DETECTS CONDITIONS OUTSIDE OF SAFETY PARAMETERS PRIOR TO AND DURING TREATMENT. NO DEVICE OR HAND PIECE ISSUES WERE FOUND DURING THE EVALUATION. THE VASER AMPLIFIER PASSED ALL INCOMING CHECKS, SELF-TESTS, AND ULTRASOUND BOARD TESTING. THE HAND PIECES ALSO PASSED FUNCTIONAL AND SAFETY TESTING. AN INDEPENDENT MEDICAL REVIEW WAS PERFORMED BY A BOARD-CERTIFIED PHYSICIAN WITH EXTENSIVE VASER EXPERIENCE ON THE INFORMATION AVAILABLE REGARDING THIS EVENT. THE REVIEW OF THIS EVENT FOUND IT DOES NOT APPEAR THAT THE PATIENT BURNS WERE ATTRIBUTABLE TO THE VASER AMPLIFIER. BASED ON THE MEDICAL REVIEW, THIS EVENT REPRESENTS TECHNICAL MISTAKES ON THE PART OF THE SURGEON AND HAS NO RELATIONSHIP TO A MALFUNCTION OF THE VASER DEVICE. A REPRESENTATIVE FOR SOLTA MEDICAL VISITED THE DOCTOR AFTER THIS EVENT. IT WAS VERIFIED THAT THE PHYSICIAN USED THE VASER SYSTEM CORRECTLY AND HAD PERFORMED THE PROCESS SUCCESSFULLY. THE PHYSICIAN REPORTED THAT THEY ARE NOW USING A DIFFERENT STYLE OF SOLTA PROBE AND DEVICE SETTING AFTER THESE EVENTS OCCURRED. NO ADVERSE EVENTS HAVE OCCURRED SINCE THE PHYSICIAN MADE THESE CHANGES. IT WAS DETERMINED NO ADDITIONAL TRAINING WAS REQUIRED. A REVIEW OF THE DEVICE HISTORY RECORD FOR THE VASER AMPLIFIER THAT WAS IN USE AT THIS CLINIC (B)(6) SHOWED THE SYSTEM PASSED ALL REQUIRED FUNCTIONAL AND FINAL TESTING DURING MANUFACTURING. NO NON-CONFORMITIES OR ANOMALIES FOUND RELATED TO THIS COMPLAINT WHEN REVIEWING THE DEVICE HISTORY RECORD. SERVICE RECORDS SHOW THAT THERE HAVE BEEN NO COMPLAINTS OR EVENTS REPORTED FOR THIS VASER AMPLIFIER PRIOR TO THESE EVENTS. POST-MARKET ANALYSIS SHOWS THE RISK OF PATIENT BURNS FROM A LIPOSUCTION PROCEDURE WHEN USING VASER IS IMPROBABLE. THE LOT HISTORY, TREND ANALYSIS, RISK ANALYSIS AND/OR DIRECTIONS FOR USE REVIEW WERE CONSIDERED ACCEPTABLE, WITH THE PRODUCT PERFORMING WITHIN ANTICIPATED RATES. BASED ON THE MEDICAL REVIEW, THIS EVENT REPRESENTS TECHNICAL MISTAKES ON THE PART OF THE SURGEON AND HAS NO RELATIONSHIP TO A MALFUNCTION OF THE VASER DEVICE. NO CORRECTIVE ACTION IS REQUIRED.
A USER FACILITY REPORTED A BURN FOLLOWING SURGERY. A PHOTO OF THE PATIENT'S ABDOMEN WAS REVIEWED BY THE MEDICAL REVIEWER AND POST INFLAMMATORY HYPERPIGMENTATION AND ERYTHEMA ARE VISIBLE ON BOTH SIDES OF THE ABDOMEN ON THE LOWER QUADRANTS. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NO NEW INFORMATION HAS BEEN PROVIDED.
ADDITIONAL INFORMATION WAS RECEIVED BY THE USER FACILITY: A USER FACILITY REPORTED BURNS TO THE PATIENT'S ABDOMEN AND FLANKS TWO DAYS POST OPERATION FROM A VASERLIPO PROCEDURE. SECONDARY INTERVENTION (OINTMENTS, MEDICATIONS, ETC.) INVOLVED BURN CREAMS. IT IS NOTED THAT THERE WILL BE PERMANENT DAMAGE OR SCARRING. AN ADDITIONAL PICTURE OF THE PATIENT WAS REVIEWED BY THE MEDICAL REVIEWER. A BURNED AREA IS VISIBLE ON ONE SIDE OF THE LOWER ABDOMEN. THE WOUND IS HEALING IN ONE PART WITH POST INFLAMMATORY HYPERPIGMENTATION AND THE OTHER PART IS NOT HEALED COMPLETELY. NO OTHER TREATMENTS (BESIDES VASER) WERE BEING PERFORMED IN SAME AREA WHERE SYMPTOMS WERE REPORTED. THE PATIENT HASN'T UNDERGONE ANY OTHER TREATMENTS IN THE SAME SYMPTOM AREA WITHIN THE PAST 90 DAYS. THE VASER SELF-TEST WAS PERFORMED PRIOR TO THE PROCEDURE. THE PATIENT WAS ALREADY UNDER ANESTHESIA WHEN THE SYSTEM WAS TESTED. THE SYSTEM WAS IN VASER (V) MODE. THE HIGHEST AMPLITUDE LEVEL USED WAS 30% WHERE THE INJURY HAPPENED. NO SYSTEM ERRORS OCCURRED NOR WAS ANYTHING OUT OF THE ORDINARY NOTICED DURING TREATMENT. THE TOTAL TIME OF THE VASER DELIVERY WAS 6 MINUTES. APPROXIMATELY 6000-8000 ML OF TUMESCENT FLUID WAS USED. THE PROCEDURE WAS COMPLETED USING THE VASER. A SKIN PORT WAS USED AND WAS NOT DAMAGED OR MISALIGNED. A WET TOWEL BARRIER WAS UTILIZED TO PROTECT THE SKIN FROM PROBE CONTACT. A 1 AND 2 RING PROBE WAS USED FOR THE TREATMENT. THIS IS NOT THE FIRST TIME THE PROBE/CANNULA WERE USED. THE USER FACILITY STATES THAT THEY USED TO WORK WITH 80 TO 90% AMPLITUDE IN VASER MODE WITHOUT ANY PROBLEM. THEN THE PROBLEM OF BURNS STARTED TO OCCUR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1494707 | VASERLIPO SYSTEM | SYSTEM, SUCTION, LIPOPLASTY | QPB | SOLTA MEDICAL, INC | 110-0037 | ||
| 1680859 | VASERLIPO SYSTEM | SYSTEM, SUCTION, LIPOPLASTY | QPB | SOLTA MEDICAL, INC | 110-0037 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention |