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

Catalog Number	10104006
Medical Device Problem Code	Environmental Particulates (2930)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/07/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).A field service engineer was dispatched to the customer site.The catalytic converter was replaced to resolve the smoke/haze issue.Unit meets specifications and was returned to service.(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.The customer was advised to turn the unit off and leave the room.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
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 was reviewed from (b)(6) 2018 to (b)(6) 2018 and no significant trend was observed.The sra shows the risk for exposure to toxic or corrosive material to be "low." the part was not available for return and further analysis.The assignable cause of the smoke/haze issue is likely due to the catalytic 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.(b)(4).
Additional Manufacturer Narrative
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 was reviewed from (b)(6) 2018 to (b)(6) 2018 and no significant trend was observed.The sra shows the risk for exposure to toxic or corrosive material to be "low." the part was not available for return and further analysis.The assignable cause of the smoke/haze issue is likely due to the catalytic 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.(b)(4).

• Brand Name: STERRAD® 100NX ALLCLEAR STERILIZER
• Common Device Name: STERRAD® EQUIPMENT
• Manufacturer (Section D): ADVANCED STERILIZATION PRODUCTS; 33 technology drive; irvine CA 92618
• MDR Report Key: 7832733
• Report Number: 2084725-2018-00684
• Device Sequence Number: 13948327
• Product Code: MLR
• UDI-Device Identifier: 10705037048687
• UDI-Public: 10705037048687
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: K071385
• Number of Events Summarized: 1
• Summary Report (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): 08/08/2018

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 Catalogue Number: 10104006
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/08/2018
• Supplement Date Received by Manufacturer: 10/29/2018
• Initial Report FDA Received Date: 08/30/2018
• Supplement Report FDA Received Date: 10/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1