An olympus field service engineer (fse) was dispatched to investigate the issue.When the fse arrived on site, he replaced the broken grey connector.The acecide was drained and replaced without error.The fse discovered a slow leak inside the device that was caused by a cracked fluid level sensor in the tub.The fluid sensor was replaced, and some stains were cleaned inside the unit.The device was repaired according to specifications and electrical safety check was performed.If additional information is obtained a supplemental report will be filed.This mdr is being submitted retrospectively as part of a remediation effort related to recent system and process changes.A capa has been opened to manage the actions related to remediation of this issue and any required mdr reporting.
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This report is being supplemented to provide additional information based on the legal manufacturer's investigation.The following sections were updated: g4, g7, h2, h3, h4, h6, and h10.A review of the device history record confirms the subject device was shipped in accordance with specifications.Based on the results of the investigation, the connecting tube cannot be connected to the device due to breakage of the connector in the basin.The breakage is likely due to age deterioration and added stress on the connector to loosen it, or a hard object hit the connector.Based on a review of the instructions for use, the following is identified in section 3.3 'inspecting the connectors': "check the following for each connector; the connector should be fixed firmly; the o-rings should be free of abnormalities such as cracks, tears, or dents".Per the legal manufacturer, the other issues identified in the initial report (slow leak inside the device caused by a cracked fluid level sensor in the tub and stains inside the unit) have no potential to cause or contribute to death or serious injury if they were to recur.
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