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 Codes	Headache (1880); Eye Irritation (4803)
Date of Event	09/09/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter phone number: (b)(6).A field service engineer was dispatched to the customer site and identified that the catalytic converter was loose.The catalytic converter was adjusted 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 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).
Event or Problem Description
A customer reported an event of a ¿strong smell¿ or odor emitting from the sterrad® nx sterilizer, and a health care worker (hcw) experienced eye irritation and a headache.It was reported the symptoms resolved in approximately 1.5 hours with no medical treatment received, and the hcw status was noted as "fine¿.An asp field service engineer was dispatched to assess the unit onsite.The reported injuries resolved without medical treatment and were deemed to be minor; however, this event is being reported as a malfunction report subsequent to a previous serious injury.
Additional Manufacturer Narrative
Correction: omission error in the initial report was identified and corrected: block h6: health effect: clinical code: eye irritation (4803).Block h10: 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.H3: asp investigation summary: the investigation included a review of the device history record (dhr), trending analysis of the odor/smells issue, and system risk analysis (sra).Trending analysis of the odor/smells 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 replaced in resolving this issue; therefore, no parts were available for further analysis.The assignable cause of the odor/smell is likely due to the catalytic converter.The asp field service engineer adjusted 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 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: 15540111
• Report Number: 2084725-2022-00282
• Device Sequence Number: 5997009
• Product Code: MLR
• UDI-Device Identifier: 10705037014132
• UDI-Public: 10705037014132
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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): 12/27/2022

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/09/2022
• Supplement Date Received by Manufacturer: 12/23/2022
• Initial Report FDA Received Date: 10/04/2022
• Supplement Report FDA Received Date: 12/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/20/2013
• 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