A field service engineer was dispatched to the customer site and identified the oil mist filter screw was loose.The oil mist filter screw was tightened to resolve the smoke/haze issue.Unit meets specifications and was returned to service.Asp investigation summary: the investigation included a review of the device history record (dhr), trending analysis of the smoke/haze issue, and system risk analysis (sra).¿the dhr was reviewed and no issues relating the failure mode were noted.The involved unit met manufacturer specifications at the time of release.¿trending analysis of the smoke/haze issue for the sterrad® 100nx unit was reviewed within the past six months and no significant trend was observed.¿the sra shows the risk for exposure to toxic or corrosive material to be "low." ¿ no parts were replaced as a result of this issue.The assignable cause of the smoke/haze issue is the oil mist filter screw.The field service engineer tightened the screw and confirmed the sterrad® 100nx was restored to proper function after service.The issue was resolved at the customer facility.Asp will continue to track and trend this issue.Asp complaint ref #: (b)(4).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
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