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

Catalog Number	10033-004
Medical Device Problem Code	Environmental Particulates (2930)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/09/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1.Initial reporter zip code: (b)(6).A field service engineer was dispatched to the customer site.The oil mist filter o-ring was replaced to resolve the mist/haze issue.Unit meets specifications and was returned to service.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by advanced sterilization products, or its employees that the report constitutes an admission that the product, advanced sterilization products, or its employees caused or contributed to the potential event described in this report.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® nx 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 previous serious injury.
Additional Manufacturer Narrative
H3: asp investigation summary: the investigation included a review of the device history record (dhr), trending analysis of the mist/haze issue, and system risk analysis (sra).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.Trending analysis of the mist/haze issue for the sterrad® nx unit was reviewed for the prior six months from the event date, and no significant trend was observed.Review of risk documentation shows the risk for exposure to toxic or corrosive material to be "low." no parts were available for further analysis.The assignable cause of the mist/haze is likely due to the oil mist filter o-ring.The asp field service engineer replaced the part and confirmed the sterrad® nx met functional specifications after service.The issue was resolved at the customer facility.Asp will continue to track and trend this issue.Advanced sterilization products (asp) has investigated the complaints to support the rationale for the decision to cease reporting odor, mist, or haze events related to the sterrad® sterilizer vacuum subsystem.The issue is indicated in the product label warning as a known risk that occurs rarely.The probability of serious adverse health consequences is remote; therefore, asp has determined that the malfunction is no longer likely to cause or contribute to a serious adverse event if it were to recur.Asp has notified the u.S.Food and drug administration of the cease malfunction reporting decision, reference fda document number (b)(4).Asp complaint ref #: (b)(4).

• Brand Name: STERRAD® NX ALLCLEAR STERILIZER
• Common Device Name: STERRAD® NX 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: mark ongkeko ; 33 technology drive; irvine, CA 92618 ; 9495619452
• MDR Report Key: 17694909
• Report Number: 2084725-2023-00245
• Device Sequence Number: 17712566
• Product Code: MLR
• UDI-Device Identifier: 10705037048656
• UDI-Public: 10705037048656
• Combination Product (Y/N): N
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2023

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: 10033-004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/09/2023
• Supplement Date Received by Manufacturer: 10/10/2023
• Initial Report FDA Received Date: 09/06/2023
• Supplement Report FDA Received Date: 11/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/11/2023
• 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