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

Model Number 10104

Device Problem Device Emits Odor (1425)

Patient Problems Headache (1880); Unspecified Respiratory Problem (4464); Skin Inflammation/ Irritation (4545)

Event Date 11/19/2022

Event Type  malfunction  

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 odor/smells issue.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 Description

A customer reported an event of an ¿odor¿ or smell emitting from the sterrad® 100nx sterilizer, and a female health care worker (hcw) experienced minor reactions, including throat and nose irritation, skin irritation and itchiness, eye irritation, and headache.The duration of the symptoms was not specified, but reported to last for ¿hours¿.Lastly, the hcw did not receive medical attention or treatment for the symptoms, and her injury status was reported as, ¿now she¿s fine¿.An asp field service engineer was dispatched to assess the unit onsite.The reported symptoms resolved without medical treatment and have been assessed as minor.However, this event is being reported as a malfunction report subsequent to a previous serious injury.

Manufacturer Narrative

Correction: omission error in the initial report was identified and corrected: block h6: health effect: clinical code: eye irritation (4803).H3: asp investigation summary: the investigation included a review of the device history record (dhr), trending analysis of the odor/smells issue, and system risk analysis (sra).Trending analysis of the odor/smells issue 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 odor/smell is potentially due to the catalytic converter, oil mist filter, and vacuum pump oil.The asp field service engineer replaced the parts and confirmed the sterrad® 100nx met functional specifications 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 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: 15936690
• MDR Text Key: 307996151
• Report Number: 2084725-2022-00340
• Device Sequence Number: 1
• Product Code: MLR
• UDI-Device Identifier: 10705037014491
• UDI-Public: 10705037014491
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: K071385
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/28/2022

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
• Device Operator: Health Professional
• Device Model Number: 10104
• Device Catalogue Number: 10104
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/19/2022
• Initial Date FDA Received: 12/07/2022
• Supplement Dates Manufacturer Received: 12/28/2022
• Supplement Dates FDA Received: 12/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/11/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1