MAUDE Adverse Event Report: ADVANCED STERILIZATION PRODUCTS STERRAD 100NX STERILIZER ALLCLEAR 1-DR; STERRAD® EQUIPMENT

Model Number	10104-005
Medical Device Problem Code	Environmental Particulates (2930)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A field service engineer was dispatched to the customer site.The catalytic converter, oil mist filter and vacuum pump oil were replaced to resolve the smoke/haze issue.Unit meets specifications and was returned to service.Asp complaint ref #: (b)(4).
Event or Problem Description
A customer reported an event of a "smoke" or haze emitting from the sterrad® 100nx sterilizer.There was no report of any injuries or human reactions.An asp field service engineer was dispatched to assess the unit onsite.This event is being reported as a malfunction report subsequent to a serious injury.
Additional Manufacturer Narrative
H3: 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 device history record (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 for the prior six months from open date and no significant trend was observed.¿review of risk documentation shows the risk for exposure to toxic or corrosive material to be "low." the catalytic converter, oil mist filter, and vacuum pump oil were not returned for further evaluation.The assignable cause of the smoke/haze is likely due to the catalytic converter, oil mist filter, and vacuum pump oil.The asp field service engineer replaced the parts 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).

• Brand Name: STERRAD 100NX STERILIZER ALLCLEAR 1-DR
• Common Device Name: STERRAD® EQUIPMENT
• Manufacturer (Section D): ADVANCED STERILIZATION PRODUCTS; 33 technology drive; irvine CA 92618
• MDR Report Key: 11925908
• Report Number: 2084725-2021-00187
• Device Sequence Number: 3197438
• Product Code: MLR
• UDI-Device Identifier: 10705037048670
• UDI-Public: 10705037048670
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K071385
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 10104-005
• Device Catalogue Number: 10104-005
• Device Lot Number: N/A
• Was the Report Sent to FDA?: Yes
• Initial Date Received by Manufacturer: 05/20/2021
• Supplement Date Received by Manufacturer: 08/12/2021
• Initial Report FDA Received Date: 06/02/2021
• Supplement Report FDA Received Date: 08/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1