The company representative was able to replicate the reported event(s).To resolve the laser issue and system message, the interface breakout printed circuit board (pcb) was replaced.Within the laser module, an internal power supply was found burnt.The module required a replacement as a result.The system was tested and found to meet product specifications.It was discovered that the customer used an operating room power cord and not the standard power cord that comes with the system.This was followed by training provided with the operating room staff (on site and by phone).The training reviewed information about the cord (which comes with the system) is to be used only.A non-conformance-based review of the batch/lot/serial number was performed and did not reveal any potential contributing factors to the reported complaint.A manufacturing device history record (dhr) review was performed prior to product release to ensure that the product was manufactured in compliance with the device master record.Based on the assessment, the product met release criteria.A review for complaints reported against this lot/batch/serial number was performed.A potentially relevant complaint was found and reviewed as part of this investigation.It was later determined to not be relevant to the reported issue.The root cause of the laser issue is attributed to the nonconforming interface breakout pcb.The root cause of the reported burnt odor can be attributed to use error.Manufacturer will continue to monitor data for evidence of adverse trending and take further action, as appropriate.The manufacturer internal reference number is: (b)(4).
|