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

Catalog Number	10104
Medical Device Problem Code	Environmental Particulates (2930)
Health Effect - Clinical Codes	Headache (1880); Itching Sensation (1943); Burning Sensation (2146); No Code Available (3191)
Date of Event	08/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The catalytic converter was tightened/adjusted during a phone support call with the customer's site biomed to resolve the haze/mist issue.An asp field service engineer followed up with the customer on site and confirmed the issue was resolved and the unit meets specifications and was returned to service.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).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 haze/mist issue was reviewed within the past six months 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 haze/mist issue is the catalytic converter.The part was tightened/adjusted and the fse followed up and confirmed the sterrad® 100nx was restored to proper function.The issue was resolved at the customer facility.Asp will continue to track and trend this issue.(b)(6).(b)(4).Asp complaint ref #: (b)(4).
Event or Problem Description
A customer reported an event of an "intermittent fog" or a haze/mist emitting from the sterrad® 100nx sterilizer.Two healthcare workers (hcw's) experienced itchiness in the nose, throat discomfort, "burning when inhale," and a "soft headache." the symptoms lasted only during exposure and the hcw's did not receive medical attention or treatment, and both were noted to be "normal" or fine.Based on the information received in the complaint, the hcws' respiratory and neurological symptoms suggest the event was not serious.However, this event is being reported as a malfunction subsequent to a serious injury for the report of haze/mist.

• Brand Name: STERRAD® 100NX STERILIZER 1-DR
• Common Device Name: STERRAD® EQUIPMENT
• Manufacturer (Section D): ADVANCED STERILIZATION PRODUCTS; 33 technology drive; irvine CA 92618
• MDR Report Key: 8993054
• Report Number: 2084725-2019-00939
• Device Sequence Number: 3330877
• Product Code: MLR
• UDI-Device Identifier: 10705037014491
• UDI-Public: 10705037014491
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K071385
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/21/2019

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: 10104
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2019
• Initial Report FDA Received Date: 09/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1