Original submission narrative: the device referenced in this report was returned to siemens for evaluation.Visual inspection showed the articulation sleeve was torn, most likely due to friction with the disinfection tube.The disinfection tube may have compromised and perforated the articulation material.This can cause the liquid to infiltrate into the articulation sleeve which affected the electrical parts that led to the system error.A functional test was performed and the reported system error message was able to be reproduced.A review of the device history record (dhr) was performed and there is no information to indicate any non-conformance at the time of manufacturing process.Follow-up narrative: this supplemental report is being submitted to update the device available for evaluation, update the follow-up type , update the device evaluated by manufacturer, update the event problem and evaluation codes, and provide the investigation results.Investigation: during the device investigation, the system error was reproduced and the articulation sleeve was found to be torn by an external force.Liquid had infiltrated into articulation sleeve, which would have affected the electrical parts.It was recommended for the customer to not use the disinfection tube.Note: the original emdr was submitted to the non-production environment.This report is to submit to the production environment.This emdr contains both the initial and fu#1.
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As a result of a recent fda inspection, we are retrospectively reviewing complaints and associated documents for compliance to the regulations from 2015 to date.We have strengthened our mdr reporting criteria and we are reporting the attached medical device report in accordance with our new criteria.As a result of this retrospective review, this mdr is being reported immediately upon discovery.It was reported that the 3d transesophageal echocardiography (tee) probe overheated and the ultrasound system froze while the patient was double intubated.A usacquisitionhw_40_0 error message was also displayed.Another system was brought in and the initial probe was removed.A new probe was obtained to complete the procedure.There was no patient injury reported.No additional information was provided.
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