The customer reported that the facility's tfl-pls power supply failed and then the unit began smoking.The event was found during preparation for use in an unspecified therapeutic procedure.There were no reports of patient harm.This event includes two (2) reports.Report with patient identifier (b)(6) laser system model tfl-pls , serial number (b)(6).Report with patient identifier (b)(6)-laser fiber- tfl-fbx550s, lot unknown.This report being submitted is for report with patient identifier (b)(6)-laser system model tfl-pls , serial number (b)(6).
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This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, a definitive root cause could not be established.The probable cause of the power supply failing and smoking could not be determined.The console was not returned to be serviced, attempts to contact the customer yielded no response.A physical evaluation could not be performed.Moreover, console device history reviews (dhr(s)) were reviewed and it was found that there were no discernible scrap, non-conformance reports (ncrs), or recorded process deviations related to the user request.Per soltive laser system instructions for use (ifu): "the soltive laser system is designed for maximum safety and performance.Under normal operating conditions and careful use, a maintenance check of the device is recommended by a qualified technician, every 12 months.¿ olympus will continue to monitor field performance for this device.
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