MAUDE Adverse Event Report: ADVANCED STERILIZATION PRODUCTS STERRAD 100NX STERILIZER ALLCLEAR 2-DR DUO; STERRAD EQUIPMENT

Model Number	10104-008
Medical Device Problem Code	Environmental Particulates (2930)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Service details are unknown at this time and asp is continuing to follow-up for the issue resolution.Initial reporter phone number: (b)(6).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Asp complaint ref #: (b)(4).
Event or Problem Description
A customer reported an event of a "mist" 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
A field service engineer was dispatched to the customer site.The adapter converter was replaced to resolve the haze/mist issue.Unit meets specifications and was returned to service.H3: asp investigation summary: the investigation included a review of the device history record (dhr), trending analysis of the haze/mist 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 haze/mist issue for the sterrad® 100nx unit was reviewed for the prior six months from open date and no significant trend was observed.¿the sra shows the risk for exposure to toxic or corrosive material to be "low." the adapter converter was not returned for further evaluation.The assignable cause of the haze/mist is likely due to the adapter converter.The field service engineer replaced the part 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 2-DR DUO
• Common Device Name: STERRAD EQUIPMENT
• Manufacturer (Section D): ADVANCED STERILIZATION PRODUCTS; 33 technology drive; irvine CA 92618
• MDR Report Key: 11499357
• Report Number: 2084725-2021-00049
• Device Sequence Number: 11886442
• Product Code: MLR
• UDI-Device Identifier: 10705037048700
• UDI-Public: 10705037048700
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2021

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: 10104-008
• Device Catalogue Number: 10104-008
• Device Lot Number: N/A
• Was the Report Sent to FDA?: Yes
• Initial Date Received by Manufacturer: 02/22/2021
• Supplement Date Received by Manufacturer: 04/16/2021
• Initial Report FDA Received Date: 03/16/2021
• Supplement Report FDA Received Date: 04/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1