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

Model Number	10033-004
Medical Device Problem Code	Environmental Particulates (2930)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A field service engineer replaced catalytic converter and the oil mist filter to resolve the haze/mist issue.Unit meets specifications and was returned to service.The device history record (dhr) was reviewed and no issues relating to the failure mode were noted.The involved unit met manufacturer specifications at the time of release.Asp complaint ref #: (b)(4).
Event or Problem Description
While on site for the installation of the sterrad® nx sterilizer, the asp field service engineer observed a ¿haze¿ or mist emitting from the unit.There was no report of any injuries or human reactions.This event is being reported as a malfunction report subsequent to a serious injury.
Additional Manufacturer Narrative
The sterrad® nx unit was returned to the product analysis lab for further evaluation.The unit successfully completed 10 standard cycles with no evidence of oil mist emitted from the machine.Asp complaint ref #: (b)(4).
Additional Manufacturer Narrative
H3: asp investigation summary: the investigation included a review of the device history record (dhr), trending analysis of the haze/mist issue, system risk analysis (sra), and functional analysis.Trending analysis of the haze/mist issue for the sterrad® nx 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 oil mist filter and catalytic converter were visually inspected via media sent in by the field service engineer.It was observed via the media file the cartridge filter subcomponent removed from the oil mist filter assembly was canted at one end.A second media file displayed smoke/haze issuing from the vacuum subsystem assembly.Functional testing was not performed as the components were not available for further evaluation.The assignable cause of the haze/mist is likely due to the catalytic converter and oil mist filter.The asp field service engineer replaced the parts and confirmed the sterrad® nx 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® NX ALLCLEAR STERILIZER
• Common Device Name: STERRAD® EQUIPMENT
• Manufacturer (Section D): ADVANCED STERILIZATION PRODUCTS; 33 technology drive; irvine CA 92618
• Manufacturer (Section G): ADVANCED STERILIZATION PRODUCTS; 33 technology drive; irvine CA 92618
• Manufacturer Contact: gabriela mclellan ; 33 technology drive; irvine, CA 92618 ; 9495030264
• MDR Report Key: 12783040
• Report Number: 2084725-2021-00393
• Device Sequence Number: 3684531
• Product Code: MLR
• UDI-Device Identifier: 10705037048656
• UDI-Public: 10705037048656
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K042116
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/25/2022

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: 10033-004
• Device Catalogue Number: 10033-004-01
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2022
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/13/2021
• Supplement Date Received by Manufacturer: 01/06/2022; 01/31/2022
• Initial Report FDA Received Date: 11/09/2021
• Supplement Report FDA Received Date: 01/27/2022; 02/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/02/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown