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

Model Number 10104

Device Problem Device Emits Odor (1425)

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

Event Date 05/12/2022

Event Type  malfunction  

Event Description

An asp representative received a report of ¿smells of smoke¿ or odor emitting from the sterrad® 100nx sterilizer that occurred on (b)(6) 2022.There was no report of any injuries or human reactions.This event is being reported as a malfunction report subsequent to a serious injury.

Manufacturer Narrative

Initial reporter phone number: (b)(6).Details of the resolution are unknown at this time, and advanced sterilization products will continue to follow-up for the issue resolution.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.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).

Manufacturer Narrative

A field service engineer (fse) was dispatched to assess the unit onsite and identified a leak in the connector for the vacuum pump.He recommended replacement of the part to resolve the odor/smells issue; however, the customer has declined service and the system was not restored to manufacturer specifications.The customer will be advised that their sterrad® 100nx unit is out of compliance and use is not recommended until service is performed.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® 100nx unit was reviewed for the prior six months from 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 as the customer has declined the recommended service.The assignable cause of the odor/smell could not be verified since the customer declined the recommended service, and the sterrad® 100nx was not returned to specifications.The customer will be advised to avoid using the unit until it is in compliance with manufacturer specifications.Asp will continue to track and trend this issue.Asp complaint ref #: (b)(4).

Manufacturer Narrative

On (b)(6) 2023, asp became aware of data omission error in the initial medwatch report.Correction: the field service engineer replaced the vacuum pump fitting to resolve the odor/smells issue.Unit met specifications and was returned to service.No parts were available for further analysis.The assignable cause of the odor/smell is likely due to the vacuum pump fitting.The field service engineer replaced the part 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 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: 14760668
• MDR Text Key: 302934201
• Report Number: 2084725-2022-00182
• Device Sequence Number: 1
• Product Code: MLR
• UDI-Device Identifier: 10705037014491
• UDI-Public: 10705037014491
• Combination Product (y/n): N
• Reporter Country Code: PA
• PMA/PMN Number: K071385
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/17/2023

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
• Device Operator: Health Professional
• Device Model Number: 10104
• Device Catalogue Number: 10104
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 06/02/2022
• Initial Date FDA Received: 06/21/2022
• Supplement Dates Manufacturer Received: 07/22/2022; 07/26/2023
• Supplement Dates FDA Received: 08/18/2022; 08/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/13/2016
• 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