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

Model Number 10104

Device Problem Smoking (1585)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/05/2021

Event Type  malfunction  

Manufacturer Narrative

A field service engineer was dispatched to the customer site.The oil mist filter screw was loose producing an excessive exhaust through the catalytic converter.The fse tightened the oil mist filter screw 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 a "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 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." no parts were replaced as a result of this issue.The assignable cause of the smoke/haze is likely due to the oil mist filter screw.The field service engineer tightened the part 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 STERILIZER 1-DR
• Type of Device: STERRAD EQUIPMENT
• Manufacturer (Section D): ADVANCED STERILIZATION PRODUCTS; 33 technology drive; irvine CA
• MDR Report Key: 11225335
• MDR Text Key: 229654131
• Report Number: 2084725-2021-00005
• Device Sequence Number: 1
• Product Code: MLR
• UDI-Device Identifier: 10705037014491
• UDI-Public: 10705037014491
• 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,health
• Type of Report: Initial,Followup
• Report Date: 02/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2021
• 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 the Report Sent to FDA?: Yes
• Date Manufacturer Received: 02/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1