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

Model Number 10104-007

Device Problem Smoking (1585)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/01/2021

Event Type  malfunction  

Manufacturer Narrative

A field service engineer was dispatched to the customer site.The adapter converter, catalytic converter, and oil mist filter were replaced to resolve the smoke/haze issue.Unit meets specifications and was returned to service.Asp complaint ref #: (b)(4).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

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 turn the unit off and leave the room.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

H3: asp investigation summary: the investigation included a review of the device history record (dhr), trending analysis of the smoke/haze issue, functional analysis, 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 for the prior six months from open date and no significant trend was observed.The sra shows the risk for exposure to toxic or corrosive material to be "low." the adapter converter, catalytic converter, and oil mist filter were returned and the adapter converter was observed to be cracked and broken where it attached to the oil mist filter.The reason for the return of the parts was confirmed.The assignable cause of the smoke/haze is likely due to the adapter converter, catalytic converter, and oil mist filter.The field service engineer replaced 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.Asp complaint ref #: (b)(4).

• Brand Name: STERRAD 100NX ALLCLEAR STERILIZER 1-DR DUO
• Type of Device: STERRAD EQUIPMENT
• Manufacturer (Section D): ADVANCED STERILIZATION PRODUCTS; 33 technology drive; irvine CA
• MDR Report Key: 11335487
• MDR Text Key: 233464957
• Report Number: 2084725-2021-00032
• Device Sequence Number: 1
• Product Code: MLR
• UDI-Device Identifier: 10705037048694
• UDI-Public: 10705037048694
• Combination Product (y/n): N
• PMA/PMN Number: K071385
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 03/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2021
• 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
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 03/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1