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

Model Number	10033
Medical Device Problem Code	Device Emits Odor (1425)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2022
Type of Reportable Event	Malfunction
Event or Problem Description
While onsite for a separate issue, the field service engineer noted a ¿haze¿ or mist emitting from the sterrad® nx sterilizer.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
Initial reporter phone number: (b)(6).The field service engineer replaced the adapter converter, catalytic converter, oil mist filter, vacuum pump oil, and the oil return solenoid valve and male connector to resolve the haze/mist issue.Unit meets specifications and was returned to service.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
Additional parts were returned for further analysis on 07-dec-2022.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 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." the oil return solenoid valve and male tube connector were returned and successfully completed a test cycle with no mist, odor, smells, vapor, or smoke observed.The reason for the return and failure of the oil return solenoid valve and male tube connector was not confirmed.The assignable cause of the haze/mist is likely due to the adapter converter, catalytic converter, oil mist filter, vacuum pump oil, oil return solenoid valve and the male tube connector.The asp field service engineer replaced the parts 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).
Additional Manufacturer Narrative
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.The oil mist filter was returned, and the visual inspection noted a broken and deteriorated hose connector.The reason for the return and failure of the oil mist filter was confirmed.A filter replacement element was returned and successfully completed a test cycle with no failures or faults.No mist, odor, smells, vapor, or smoke was observed.Visual inspection yielded no unusual findings, problems, defects, or anomalies.The reason for the return and failure of the filter replacement element was not confirmed.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: 15303465
• Report Number: 2084725-2022-00254
• Device Sequence Number: 20155478
• Product Code: MLR
• UDI-Device Identifier: 10705037014132
• UDI-Public: 10705037014132
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/22/2022

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?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/05/2022
• Supplement Date Received by Manufacturer: 10/19/2022; 12/07/2022
• Initial Report FDA Received Date: 08/26/2022
• Supplement Report FDA Received Date: 11/03/2022; 12/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/24/2012
• 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