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

Model Number 10104-005

Device Problem Device Emits Odor (1425)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/13/2022

Event Type  malfunction  

Event 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 serious injury.

Manufacturer Narrative

Initial reporter phone number: (b)(6).A field service engineer was dispatched to the customer site.The catalytic converter was replaced, and the oil mist filter was cleaned to resolve the odor/smells issue.Unit meets specifications and was returned to service.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).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.Trending analysis of the odor/smells 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." no parts were available for further analysis.The assignable cause of the odor/smell is likely due to the catalytic converter and the oil mist filter.The asp field service engineer replaced/cleaned the parts and confirmed the sterrad® 100nx was restored to proper function after service.The issue was resolved at the customer facility.Asp will continue to track and trend this issue.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).

• Brand Name: STERRAD® 100NX ALLCLEAR STERILIZER 1-DR
• Type of Device: 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: 14956803
• MDR Text Key: 303247744
• Report Number: 2084725-2022-00195
• Device Sequence Number: 1
• Product Code: MLR
• UDI-Device Identifier: 10705037048670
• UDI-Public: 10705037048670
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K071385
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 07/08/2022

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
• Device Operator: Health Professional
• Device Model Number: 10104-005
• Device Catalogue Number: 10104-005
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 06/13/2022
• Initial Date FDA Received: 07/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/25/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1