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

Model Number	10104-003
Medical Device Problem Code	Environmental Particulates (2930)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A customer reported an event of a ¿mist¿ or vapor emitting from the sterrad® 100nx sterilizer.There was no report of any injuries or human reactions.The customer was instructed to power off the unit and discontinue use.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
A field service engineer was dispatched to the customer site and identified a mist emitting from the vacuum subsystem; however, details of the resolution are unknown as the customer did not authorize the repair.Asp will continue to follow up regarding this issue.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.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
H3: asp investigation summary: the investigation included a review of the device history record (dhr), trending analysis of the mist/vapor issue, system risk analysis (sra), and functional analysis.Trending analysis of the mist/vapor issue for the sterrad® 100nx unit was reviewed for the prior six months from open 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 catalytic converter and oil mist filter were returned and successfully completed test cycles with no evidence of smoke/haze/mist/vapor or odor/smell.The reason for the return and failure of the catalytic converter and oil mist filter could not be confirmed.Although functional analysis could not replicate the reported issue, the assignable cause of the mist/vapor is likely due to the catalytic converter and oil mist filter.The asp field service engineer replaced the parts and confirmed that the issue was resolved; however, the unit was not returned to specifications as the planned maintenance was overdue.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
An asp field service engineer (fse) replaced the catalytic converter and oil mist filter to resolve the mist/vapor issue; however, the unit was not returned to specifications as the planned maintenance was overdue.The customer will be advised to avoid using the unit until it is in compliance with manufacturer specifications.Asp complaint ref #: (b)(4).

• Brand Name: STERRAD® 100NX STERILIZER 1-DR W/ 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: gabriela mclellan ; 33 technology drive; irvine, CA 92618 ; 9495030264
• MDR Report Key: 13930510
• Report Number: 2084725-2022-00060
• Device Sequence Number: 12351670
• Product Code: MLR
• UDI-Device Identifier: 10705037047581
• UDI-Public: 10705037047581
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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: Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/14/2022

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: 10104-003
• Device Catalogue Number: 10104-003
• 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: 03/04/2022
• Supplement Date Received by Manufacturer: 04/14/2022; 05/25/2022
• Initial Report FDA Received Date: 03/28/2022
• Supplement Report FDA Received Date: 04/19/2022; 06/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/20/2016
• 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