MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-12-20 for CLEAR + BRILLIANT LASER SYSTEM CB-HP-1927 manufactured by Solta Medical.
[130992755]
No product returned for evaluation. The clear & brilliant system has no system/data logs that can be reviewed. System has software safeguards (such as a power on self-test) that will trigger error/event codes should system be outside of acceptable limits. Customer can also utilize the burn paper to confirm system laser is providing correct pattern/coverage. Pattern paper testing was requested after the event. The burn paper showed proper pattern/coverage; however, the customer encountered e129 error (loses self test fail energy). Prior to this request, the customer reported using the clear+brilliant system successfully with the 1440 handpiece. This error occurred due to improperly switching between the 1440 and 1927 handpiece after the event. E129 can be caused by hot swapping or plugging in the handpiece connector upside down. If the customer removes a handpiece with the power on it could affect the calibration data (energy table) which is stored in the handpiece on the u5 (1-wire eerom memory). This table is constructed during the calibration process. The table can be corrupted, forcing the handpiece to default back to the factory settings. Most likely it can be recovered by recalibrating the handpiece. Field service recalibrated the customer? S handpiece and all functional testing passed. This error did not cause patient inflammation. According to clear+brilliant user manual (p009341-02 rev. A) edema or oedema is a known and expected response to treatment. Mild to moderate edema (swelling) typically develops immediately after treatment and diminishes or resolves within 12 to 24 hours after treatment. A small degree of swelling may last longer in some cases. The lot/device history review and/or trend analysis was considered acceptable and the product is performing within anticipated rates. No corrective action is necessary. Final test verification specifications are acceptable per document number 91290. No non-conformities or anomalies found related to this complaint when reviewing the device history record for serial/lot number (b)(4). Trending will be performed to monitor this issue. No further action is required at this time. The investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
[130992756]
After a clear + brilliant treatment a patient experienced inflammation on the zygomatic area and buccal area on both sides of the face. The doctor recommended "predisolone" oral, cortisone topical and anti-histamines. There will be no permanent damage or scarring and the patient's current status is that the inflammation has mostly settled. The highest energy level used was 1927 high level. No system errors occurred and nothing out of the ordinary was observed during the treatment. This was the initial use of the treatment tip, and a burn pattern test was successfully performed prior to use which showed normal microscopic dermal zones.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011423170-2018-00138 |
| MDR Report Key | 8184175 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-12-20 |
| Date of Report | 2018-09-04 |
| Date of Event | 2018-08-28 |
| Date Added to Maude | 2018-12-20 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. JULI MOORE |
| Manufacturer Street | 3365 TREE COURT INDUSTRIAL BLV |
| Manufacturer City | ST. LOUIS MO 63122 |
| Manufacturer Country | US |
| Manufacturer Postal | 63122 |
| Manufacturer Phone | 6362263220 |
| Manufacturer G1 | SOLTA MEDICAL |
| Manufacturer Street | 11720 N CREEK PARKWAY N STE 100 |
| Manufacturer City | BOTHELL WA 98011 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 98011 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CLEAR + BRILLIANT LASER SYSTEM |
| Generic Name | POWERED LASER SURGICAL INSTRUMENT WITH MICROBEAM |
| Product Code | ONG |
| Date Received | 2018-12-20 |
| Model Number | CB-HP-1927 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SOLTA MEDICAL |
| Manufacturer Address | 11720 N CREEK PARKWAY N STE100 BOTHELL WA 98011 US 98011 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-12-20 |