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

Model Number 10104-007

Device Problem Smoking (1585)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/29/2020

Event Type  malfunction  

Manufacturer Narrative

A field service engineer was dispatched to the customer site.The catalytic converter was replaced to resolve the smoke/haze issue.Unit meets specifications and was returned to service.Asp complaint ref #: (b)(4).

Event Description

A customer reported an event of smoke or haze emitting from the sterrad® 100nx sterilizer.There was no report of any injuries or human reactions.The customer was advised to discontinue use of unit and avoid working in room until the smoke cleared.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

Additional follow-up confirmed the oil mist filter was loose.Therefore, the oil mist filter was adjusted in addition to replacing the catalytic converter to resolve the smoke/haze issue.Asp investigation summary: the investigation included a review of the device history record (dhr), trending analysis of the smoke/haze issue, and system risk analysis (sra).¿the dhr was reviewed and no issues relating the failure mode were noted.The involved unit met manufacturer specifications at the time of release.¿trending analysis of the smoke/haze issue for the sterrad® 100nx unit was reviewed within the past six months and no significant trend was observed.¿the sra shows the risk for exposure to toxic or corrosive material to be "low." ¿ the parts were not available for return and further analysis.The assignable cause of the smoke/haze issue is the catalytic converter and oil mist filter.The field service engineer replaced the catalytic converter and adjusted the oil mist filter 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.Asp complaint ref #: (b)(4).

• Brand Name: STERRAD 100NX ALLCLEAR 1-DR DUO
• Type of Device: STERRAD® EQUIPMENT
• Manufacturer (Section D): ADVANCED STERILIZATION PRODUCTS; 33 technology drive; irvine CA
• 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: 10426659
• MDR Text Key: 204078094
• Report Number: 2084725-2020-50176
• Device Sequence Number: 1
• Product Code: MLR
• UDI-Device Identifier: 10705037048694
• UDI-Public: 10705037048694
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071385
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10104-007
• Device Catalogue Number: 10104-007
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 08/25/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2000
• 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