MAUDE Adverse Event Report: ADVANCED STERILIZATION PRODUCTS STERRAD® 100S STERILIZER; STERRAD EQUIPMENT

Model Number 10101

Device Problem Smoking (1585)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/07/2020

Event Type  malfunction  

Manufacturer Narrative

A field service engineer was dispatched to the customer site.The oil mist filter and vacuum pump oil were replaced to resolve the mist/haze issue.Unit meets specifications and was returned to service.Asp complaint ref #: (b)(4).

Event Description

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

The device history record (dhr) was reviewed for the sterrad® unit and no anomalies were observed that would contribute to the reported issue at the time of release.Asp complaint ref #: (b)(4).

Manufacturer Narrative

Asp investigation summary: the investigation included a review of the device history record (dhr), trending analysis of the haze/mist issue and system risk analysis (sra).Trending analysis of the haze/mist issue was reviewed from to and no significant trend was observed.The sra shows the risk for exposure to toxic or corrosive material to be "low." no parts were available for return and further analysis.The assignable cause of the haze/mist issue is likely due to the oil mist filter and vacuum pump oil.The field service engineer replaced the parts and confirmed the sterrad® 100s 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® 100S STERILIZER
• Type of Device: STERRAD EQUIPMENT
• Manufacturer (Section D): ADVANCED STERILIZATION PRODUCTS; 33 technology drive; irvine CA
• MDR Report Key: 9634939
• MDR Text Key: 181332897
• Report Number: 2084725-2020-50003
• Device Sequence Number: 1
• Product Code: MLR
• UDI-Device Identifier: 10705037014460
• UDI-Public: 10705037014460
• Combination Product (y/n): N
• PMA/PMN Number: K991999
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 06/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10101
• Device Catalogue Number: 10101
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 06/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1