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

Catalog Number	10100
Medical Device Problem Code	Environmental Particulates (2930)
Health Effect - Clinical Code	Red Eye(s) (2038)
Date of Event	02/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A field service engineer was dispatched to the customer site.The catalytic converter, oil mist filter, and vacuum pump oil were replaced to resolve the mist/haze issue.Unit meets specifications and was returned to service.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).
Event or Problem Description
A customer reported an event of "steam" or haze emitting from their sterrad 100s sterilizer and ten healthcare workers (hcws) experienced reactions of eye irritation and scratchy throats.A separate complaint has been opened for each healthcare worker.This complaint is for a hcw who experienced an eye reaction and went home the day of the incident.Advanced sterilization products (asp) requested additional information regarding their symptoms but has received nothing further to date.An asp field service engineer was dispatched to assess the unit onsite.Based on limited information received, the reported symptoms of eye reaction suggest the event was 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
Concomitant medical devices: device returned to manufacturer correction from no to yes.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." the catalytic converter was returned and tested.The catalytic converter did not exhibit any smoke, vapor or mist.The reason for return of the catalytic converter was not confirmed.The oil mist filter was returned and tested.The oil mist filter did not exhibit any smoke, vapor or mist.The reason for return of the oil mist filter was not confirmed.The vacuum pump oil was not returned for functional evaluation.The assignable cause of the haze/mist issue is likely due to the oil mist filter, catalytic converter and vacuum pump oil.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: 8362169
• Report Number: 2084725-2019-00827
• Device Sequence Number: 17251495
• Product Code: MLR
• Combination Product (Y/N): N
• PMA/510(K) Number: K991999
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Type of Report: Initial,Followup
• Report Date (Section B): 02/04/2019

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: 10100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2019
• Initial Date Received by Manufacturer: 02/04/2019
• Supplement Date Received by Manufacturer: 04/05/2019
• Initial Report FDA Received Date: 02/22/2019
• Supplement Report FDA Received Date: 04/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1