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 2018-11-27 for FRAXEL RE:STORE LASER SYSTEM MCSR1500-D-INTL manufactured by Solta Medical.
[128474155]
Field service information: cleaned self test port and handpiece glass windows. Connected teraterm and reviewed system logs, found that self test <5%. Performed laser calibration on fraxel dual - passed. Conducted laser output verification? Passed. Checked operation of emergency stop and door interlock? All working fine. Performed stationary burn and functional burn tests? All passed. Instrument performs in accordance with manufacturers specifications. Additional information has been requested yet not received. The investigation is ongoing.
Patient Sequence No: 1, Text Type: N, H10
[128474156]
A facility reported they are experiencing more incidents of blisters using very conservative settings with their fraxel system.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011423170-2018-00119 |
| MDR Report Key | 8107752 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-11-27 |
| Date of Report | 2018-10-28 |
| Device Manufacturer Date | 2011-05-03 |
| Date Added to Maude | 2018-11-27 |
| 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 STE100 |
| 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 | FRAXEL RE:STORE LASER SYSTEM |
| Generic Name | POWERED LASER SURGICAL INSTRUMENT WITH MICROBEAM |
| Product Code | ONG |
| Date Received | 2018-11-27 |
| Model Number | MCSR1500-D-INTL |
| 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 SUITE 100 BOTHELL WA 98011 US 98011 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-11-27 |