Since the device was not returned, it is impossible to proceed to actual evaluation.But, it was confirmed from the device history record that device had been manufactured with no significant issue and passed all the inspections successfully.It is impossible to identify the exact root cause since the device was not returned and it is hard to recreate the situation at the time of procedure with limited information.Investigation will be conducted once device is returned and if there is any update we will send follow-up report accordingly.We will continuously monitor whether similar or same complaint occurs.
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As a result of investigation of returned device, outer sheath was detached, stent was loaded, and mark being kinked were found near stent loaded part and yellow marker.Deployment was tried in the state without pressure, and it worked well.Esophageal structure where procedure was performed has active peristalsis.It can be hard to deploy due to pressure generated by patient's lesion status.Outer sheath can be stretched and detached and it can cause deployment failure if deployment was tried in this situation.It is, however, impossible to identify the exact root cause since there is no patient information and it is hard to recreate the situation at the time of procedure.It is regarded that outer sheath got pressured by patient's lesion status and deployment was tried in this situation according to the investigation in which deployment was successful in the state without pressure.It seems that deployment failure occurred since it was hard to deploy due to kinked outer sheath and it caused detachment of outer sheath.We will continuously monitor whether similar or same complaint occurs.For "a.Patient information", we, taewoong and our distributor could not get more detailed patient information because the hospital did not open them such as "2.Age at time of event", "date of birth", "3.Sex" and "4.Weight".
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