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

Catalog Number	10101
Medical Device Problem Code	Environmental Particulates (2930)
Health Effect - Clinical Code	Itching Sensation (1943)
Date of Event	03/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A field service engineer was dispatched to the customer site.The oil mist filter was replaced to resolve the smoke/haze issue.Unit meets specifications and was returned to service.(b)(4).
Event or Problem Description
A customer reported smoke was emitting from the sterrad® 100s sterilizer.Several healthcare workers (hcw's) experienced a reaction.This file is for hcw # 1 who experienced tingling in her nose and throat and reported she felt like she ¿needs to clear her throat constant for the last 10 minutes.¿.No medical attention had been sought at the time the event was reported.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.Based on limited information received in the complaint at the time the reporting decision was made, the information suggests the respiratory symptoms were not serious.Furthermore, there is no report that medical or surgical intervention was required to preclude a permanent impairment of a body function or permanent damage to a body structure; however, this event is being reported as a malfunction subsequent to a serious injury.
Additional Manufacturer Narrative
The dhr was reviewed and no issues relating the failure mode were noted.The involved unit met manufacturer specifications at the time of release.Asp complaint ref #: (b)(4).
Additional Manufacturer Narrative
Device evaluated by mfr: asp investigation summary: the investigation included a review of the device history record (dhr), trending analysis of the smoke/haze/mist issue and system risk analysis (sra).¿trending analysis of the smoke/haze/mist issue was reviewed from september 2017 to march 2018 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 not available for return and further analysis.The assignable cause of the smoke/haze/mist issue is the oil mist filter.The field service engineer replaced these 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
• Common Device Name: STERRAD® EQUIPMENT
• Manufacturer (Section D): ADVANCED STERILIZATION PRODUCTS; 33 technology drive; irvine CA 92618
• MDR Report Key: 7381840
• Report Number: 2084725-2018-00569
• Device Sequence Number: 129558
• Product Code: MLR
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K991999
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 10101
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/13/2018
• Supplement Date Received by Manufacturer: 04/02/2018; 05/10/2018
• Initial Report FDA Received Date: 03/29/2018
• Supplement Report FDA Received Date: 04/25/2018; 05/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1