MAUDE Adverse Event Report: ADVANCED STERILIZATION PRODUCTS STERRAD® 100NX STERILIZER 2-DR; STERRAD® EQUIPMENT

Model Number	10104-002
Medical Device Problem Codes	Device Emits Odor (1425); Environmental Particulates (2930)
Health Effect - Clinical Code	Unspecified Respiratory Problem (4464)
Date of Event	12/09/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).A field service engineer was dispatched to the customer site.The adapter converter, catalytic converter, and oil mist filter were replaced to resolve the mist/vapor and odor/smells issues.Unit meets specifications and was returned to service.The device history record (dhr) was reviewed and no issues relating to the failure mode were noted.The involved unit met manufacturer specifications at the time of release.This report is being submitted pursuant to the provisions of 21 cfr, part 4.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by advanced sterilization products, or its employees that the report constitutes an admission that the product, advanced sterilization products, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Asp complaint ref #: (b)(4).
Event or Problem Description
A customer reported an event of a ¿mist¿ or vapor and an ¿intense smell¿ or odor emitting from the sterrad® 100nx sterilizer, and a health care worker (hcw) reported experiencing a respiratory reaction described as a burning in the throat.The respiratory reaction disappeared when the hcw left the room, and no medical treatment was required.Lastly, the hcw status was reported as ¿in good health¿.An asp field service engineer was dispatched to assess the unit onsite.The respiratory reaction resolved without medical or surgical intervention and was assessed to be a minor injury; however, this event is being reported as a malfunction report subsequent to a previous serious injury.
Additional Manufacturer Narrative
On 31-jan-2023, asp received additional information and became aware of omission error in the initial medwatch report.Correction: the involved sterrad® 100nx was not returned to service.The field service engineer could not verify the reported mist/vapor or odor/smells issues and confirmed that the sterrad® 100nx unit was within specifications after service.However, the customer stated the reported issues were not resolved, and the sterrad® 100nx was deactivated for additional assessment.Further unit testing could not replicate the reported mist/vapor or odor/smells issues; however, additional components were subsequently replaced, including the vacuum pump, vacuum valve and o-ring.Asp complaint ref #: (b)(4).
Additional Manufacturer Narrative
H3: asp investigation summary: the investigation included a review of the device history record (dhr), trending analysis of the mist/haze and odor/smells issues, and system risk analysis (sra).¿ trending analysis of the mist/vapor and odor/smells issues for the sterrad® 100nx unit was reviewed for the prior six months from the event date, and no significant trend was observed.¿ review of risk documentation shows the risk for exposure to toxic or corrosive material to be "low." no parts were available for further analysis.The assignable cause of the mist/vapor and odor/smell is potentially due to the adapter converter, catalytic converter, and oil mist filter, as well as the vacuum pump, vacuum valve and o-ring.The asp field service engineer replaced the parts and confirmed the sterrad® 100nx met functional specifications after service.The issues were resolved and the system was returned to service.Asp will continue to track and trend this issue.Asp complaint ref #: (b)(4).

• Brand Name: STERRAD® 100NX STERILIZER 2-DR
• Common Device Name: STERRAD® EQUIPMENT
• Manufacturer (Section D): ADVANCED STERILIZATION PRODUCTS; 33 technology drive; irvine CA 92618
• Manufacturer (Section G): ADVANCED STERILIZATION PRODUCTS; 33 technology drive; irvine CA 92618
• Manufacturer Contact: gabriela mclellan ; 33 technology drive; irvine, CA 92618 ; 9495030264
• MDR Report Key: 16072765
• Report Number: 2084725-2022-00352
• Device Sequence Number: 6234618
• Product Code: MLR
• UDI-Device Identifier: 10705037014507
• UDI-Public: 10705037014507
• Combination Product (Y/N): N
• PMA/510(K) Number: K071385
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/20/2023

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 Model Number: 10104-002
• Device Catalogue Number: 10104-002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/09/2022
• Supplement Date Received by Manufacturer: 01/31/2023; 06/13/2023
• Initial Report FDA Received Date: 12/29/2022
• Supplement Report FDA Received Date: 03/01/2023; 06/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown