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 12/21/2020

Event Type  malfunction  

Manufacturer Narrative

A field service engineer was dispatched to the customer site.The adapter converter, catalytic converter, oil mist filter, and vacuum pump oil were replaced to resolve the haze/mist issue.Unit meets specifications and was returned to service.(b)(4).

Event Description

A customer reported an event of mist or haze emitting from the sterrad® 100nx sterilizer.There was no report of any injuries or human reactions.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 oil mist filter was returned for evaluation and completed functional tests with no smoke/haze observed.The reason for the return of the oil mist filter could not be confirmed.The adapter converter and catalytic converter were not returned for further evaluation.The assignable cause of the smoke/haze is likely due to the adapter converter, catalytic converter, oil mist filter, and vacuum pump oil.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 STERILIZER 1-DR
• Type of Device: STERRAD® EQUIPMENT
• Manufacturer (Section D): ADVANCED STERILIZATION PRODUCTS; 33 technology drive; irvine CA
• MDR Report Key: 11127917
• MDR Text Key: 226768258
• Report Number: 2084725-2020-50316
• 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
• Type of Report: Initial,Followup
• Report Date: 03/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2021
• 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: 03/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1