MAUDE Adverse Event Report: ADVANCED STERILIZATION PRODUCTS STERRAD® 100NX ALLCLEAR STERILIZER 1-DR DUO; STERRAD® EQUIPMENT

Model Number	10104-007
Medical Device Problem Code	Device Emits Odor (1425)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/11/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1.Initial reporter phone number: (b)(6).E1.Initial reporter state and zip code: (b)(6).A field service engineer was dispatched to the customer site.The adapter converter, catalytic converter, oil mist filter, and vacuum pump oil were replaced to resolve the odor/smells 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 ¿smell¿ or odor emitting from the sterrad® 100nx 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
Additional information reported that the oil mist filter's side was observed to be broken, and parts were contaminated with oil.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).
Additional Manufacturer Narrative
Asp product analysis lab received the adapter converter for further analysis.Visual inspection of the adapter converter found it was received broken and damaged.The threaded portion of the adapter has been sheared and torn off or broken apart.The reason for the return and failure of the adapter converter was confirmed.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 odor/smells issue, system risk analysis (sra), and visual analysis.Trending analysis of the odor/smells issue for the sterrad® 100nx 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." visual analysis of the returned adapter converter confirmed the failure.No additional parts were available for further analysis.The assignable cause of the odor/smell is likely due to the adapter converter, catalytic converter, oil mist filter, and vacuum pump oil.The asp field service engineer replaced the parts and confirmed the sterrad® 100nx 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® 100NX ALLCLEAR STERILIZER 1-DR DUO
• 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: mark ongkeko ; 33 technology drive; irvine, CA 92618 ; 9495619452
• MDR Report Key: 16873347
• Report Number: 2084725-2023-00104
• Device Sequence Number: 15300068
• Product Code: MLR
• UDI-Device Identifier: 10705037048694
• UDI-Public: 10705037048694
• Combination Product (Y/N): N
• PMA/510(K) Number: K071385
• 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,Followup,Followup
• Report Date (Section B): 11/02/2023

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: 10104-007
• Device Catalogue Number: 10104-007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/11/2023
• Supplement Date Received by Manufacturer: 05/08/2023; Not provided; 11/01/2023
• Initial Report FDA Received Date: 05/04/2023
• Supplement Report FDA Received Date: 06/01/2023; 08/30/2023; 11/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2022
• 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