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

Model Number	10033
Medical Device Problem Code	Environmental Particulates (2930)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A customer reported an event of a ¿smoke¿ or haze emitting from the sterrad® nx sterilizer.There was no report of any injuries or human reactions.A 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
Initial reporter phone number: (b)(6).A field service engineer was dispatched to the customer site.The oil mist filter was replaced to resolve the smoke/haze 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.This report is being submitted pursuant to the provisions of 21 cfr, part 4.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).
Additional Manufacturer Narrative
Correction: block b5 in the initial report contained incorrect information - the customer reported a separate issue for the sterrad® nx, and while on site to assess the unit, the field service engineer observed the smoke/haze issue.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).Trending analysis of the smoke/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 smoke/haze is likely due to the oil mist filter.The field service engineer replaced the part 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 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: 15303559
• Report Number: 2084725-2022-00256
• Device Sequence Number: 17732594
• Product Code: MLR
• UDI-Device Identifier: 10705037014132
• UDI-Public: 10705037014132
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2022

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
• Device Catalogue Number: 10033
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/04/2022
• Supplement Date Received by Manufacturer: 08/28/2022
• Initial Report FDA Received Date: 08/26/2022
• Supplement Report FDA Received Date: 09/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/25/2016
• 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