MAUDE Adverse Event Report: ADVANCED STERILIZATION PRODUCTS STERRAD® NX ALLCLEAR; 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	09/08/2021
Type of Reportable Event	Malfunction
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.Asp complaint ref #: (b)(4).
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.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
Correction: it was initially reported that a customer noticed the smoke/haze issue; however, upon secondary review, it was confirmed that an asp field service engineer observed the smoke emitting from the sterrad® nx sterilizer while onsite performing a planned maintenance on the unit.Photographs provided by the technical services representative were evaluated.The oil mist filter¿s red fiberglass media was observed burned/charred, exposing the mesh frame underneath.The reported issue was confirmed by visual analysis.The device history record (dhr) was reviewed and no issues relating the failure mode were noted.The involved unit met manufacturer specifications at the time of release.Asp complaint ref #: cmp-(b)(4).
Additional Manufacturer Narrative
H3: asp investigation summary: the investigation included a review of the device history record (dhr), trending analysis of the smoke/haze issue, system risk analysis (sra), and visual analysis.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." asp product analysis lab received the oil mist filter for further analysis, and the physical inspection observed the component to be charred and burnt inside and out.The reason for the failure and return was confirmed.The assignable cause of the smoke/haze is likely due to the oil mist filter.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.Asp complaint ref #: (b)(4).

• Brand Name: STERRAD® NX ALLCLEAR
• 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: 12577071
• Report Number: 2084725-2021-00337
• Device Sequence Number: 11739520
• Product Code: MLR
• UDI-Device Identifier: 10705037048656
• UDI-Public: 10705037048656
• Combination Product (Y/N): N
• Initial Reporter Country: ES
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/01/2023

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 Model Number: 10033-004
• Device Catalogue Number: 10033-004
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/08/2021
• Supplement Date Received by Manufacturer: 11/08/2021; 10/30/2023
• Initial Report FDA Received Date: 10/05/2021
• Supplement Report FDA Received Date: 12/06/2021; 11/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/12/2019
• 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