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

Model Number 10104

Device Problems Device Emits Odor (1425); Environmental Particulates (2930)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/07/2023

Event Type  malfunction  

Manufacturer Narrative

Initial reporter phone number: (b)(6).A field service engineer was dispatched to the customer site.The oil mist filter and o-ring were cleaned and reinstalled to resolve the mist/haze and odor/smells issues.Unit meets specifications and was returned to service.Investigation summary: the investigation included a review of the device history record (dhr), trending analysis of the mist/haze and odor/smells issue, and system risk analysis (sra).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.Trending analysis of the mist/haze 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 replaced in resolving this issue, and therefore, no parts were available for further analysis.The assignable cause of the mist/haze and odor/smell is potentially due to the oil mist filter and o-ring.The asp field service engineer cleaned and reinstalled the parts and confirmed the sterrad® 100nx met functional specifications after service.The issues were resolved at the customer facility.Asp will continue to track and trend this issue.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 a ¿mist¿ or haze emitting from the sterrad® 100nx sterilizer.There was no report of any injuries or human reactions.An asp field service engineer was dispatched to assess the unit onsite and identified an additional issue of odor/smell.This event is being reported as a malfunction report subsequent to a previous serious injury.

• 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: 16253719
• MDR Text Key: 308643991
• Report Number: 2084725-2023-00011
• Device Sequence Number: 1
• Product Code: MLR
• UDI-Device Identifier: 10705037014491
• UDI-Public: 10705037014491
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K071385
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 01/27/2023

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
• Device Operator: Health Professional
• Device Model Number: 10104
• Device Catalogue Number: 10104
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/07/2023
• Initial Date FDA Received: 01/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/12/2013
• 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