THERMAGE CPT SYSTEM
Report
- Report Number
- 3011423170-2021-00151
- Event Type
- Malfunction
- Date Received
- December 23, 2021
- Date of Event
- November 15, 2021
- Report Date
- December 7, 2021
- Manufacturer
- SOLTA MEDICAL INC.
- Product Code
- GEI
- PMA / PMN Number
- K132431
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- HI, US
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
SERVICE CONFIRMED DAMAGE TO THE TIP MEMBRANE ALONG THE RADIO FREQUENCY TRACE. BREAKDOWN OF THE DIELECTRIC MATERIAL, AND/OR BUILD-UP OF FOREIGN SUBSTANCE ON THE DIELECTRIC, CAN CAUSE THE RADIOFREQUENCY ENERGY, DELIVERED BY THE SYSTEM, TO FOCUS IN A SMALL AREA OF THE MEMBRANE, RATHER THAN TO BE UNIFORMLY DISTRIBUTED OVER THE ENTIRE MEMBRANE AREA. DEFECTS ON THE TIP MEMBRANE CAN LEAD TO A RISE IN TEMPERATURE OF THE TIP DURING TREATMENT AND CAN POTENTIALLY CAUSE PATIENT BURNS. RADIO FREQUENCY TRACE DAMAGE CAN CAUSE SPARKING DURING TREATMENT. TIP EVALUATION CONFIRMED CUSTOMER''S REPORT OF SPARKING DURING TREATMENT. A REVIEW OF THE MANUFACTURING RECORDS SHOWED ALL REQUIREMENTS WERE MET. A MEDICAL REVIEW OF THE CASE DETERMINED THAT THIS EVENT WAS NOT A SERIOUS INJURY. BASED ON THE AVAILABLE INFORMATION, THIS EVENT WAS MOST LIKELY CAUSED BY DAMAGE ON THE TIP MEMBRANE.
THE TIP WAS RETURNED AND EVALUATED. THE EVALUATION REVEALED THAT THE TIP PASSED FLOW AND THERMISTOR TESTING. THE TIP FAILED LEAK TESTING AND VISUAL INSPECTION DUE TO BURNT TRACE OBSERVED ON THE SURFACE MEMBRANE AND THE OBSERVANCE OF DIELECTRIC BREAKDOWN ON THE TIP. NO FUNCTIONAL TESTING CAN BE PERFORMED DUE TO DIELECTRIC BREAKDOWN BEING OBSERVED. A REVIEW OF THE DEVICE HISTORY RECORDS IS IN PROGRESS. BASED ON ALL AVAILABLE INFORMATION, NO CAUSAL FACTORS CAN BE DETERMINED AND NO CONCLUSION CAN BE DRAWN.
THE TIP WAS RETURNED AND EVALUATED. THE EVALUATION REVEALED THAT THE TIP PASSED FLOW AND THERMISTOR TESTING. THE TIP FAILED LEAK TESTING AND VISUAL INSPECTION DUE TO BURNT TRACE OBSERVED ON THE SURFACE MEMBRANE AND THE OBSERVANCE OF DIELECTRIC BREAKDOWN ON THE TIP. NO FUNCTIONAL TESTING CAN BE PERFORMED DUE TO DIELECTRIC BREAKDOWN BEING OBSERVED. A REVIEW OF THE DEVICE HISTORY RECORDS IS IN PROGRESS. BASED ON ALL AVAILABLE INFORMATION, NO CAUSAL FACTORS CAN BE DETERMINED AND NO CONCLUSION CAN BE DRAWN.
A NURSE REPORTED THAT DURING A THERMAGE TREATMENT THE TIP SPARKED AT 1095 REPS ON THE PATIENT''S FOREHEAD. THE HIGHEST ENERGY USED WAS 3.0, AND 1.5 WHILE TREATING THE FOREHEAD. THERE WERE NO SYSTEM ERRORS DURING THIS TREATMENT BUT THE COOLANT WAS REPLACED. THE TIP WAS INSPECTED BEFORE TREATMENT AND AT 450 REPS. THE PRACTITIONER CHANGED THE TIP AND PROCEEDED WITH THE TREATMENT, WITH NO ADDITIONAL ISSUES. THE PATIENT EXPERIENCED PAIN AND A SMALL FOREHEAD SCAB. THE REVIEWED PHOTOGRAPHS SHOWED ERYTHEMA AND ONE PINPOINT SCAB ON THE FOREHEAD. THERE WAS NO SERIOUS INJURY.
A NURSE REPORTED THAT DURING A THERMAGE TREATMENT THE TIP SPARKED AT 1095 REPS ON THE PATIENT''S FOREHEAD. THE HIGHEST ENERGY USED WAS 3.0, AND 1.5 WHILE TREATING THE FOREHEAD. THERE WERE NO SYSTEM ERRORS DURING THIS TREATMENT BUT THE COOLANT WAS REPLACED. THE TIP WAS INSPECTED BEFORE TREATMENT AND AT 450 REPS. THE PRACTITIONER CHANGED THE TIP AND PROCEEDED WITH THE TREATMENT, WITH NO ADDITIONAL ISSUES. THE PATIENT EXPERIENCED PAIN AND A SMALL FOREHEAD SCAB. THE REVIEWED PHOTOGRAPHS SHOWED ERYTHEMA AND ONE PINPOINT SCAB ON THE FOREHEAD. THERE WAS NO SERIOUS INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1976541 | THERMAGE CPT SYSTEM | ELECTROSURGICAL,CUTTING & COAGULATION & ACC. | GEI | SOLTA MEDICAL INC. | TTNS3.00E4-1200 | 222 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |