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

Model Number 10101

Device Problem Device Emits Odor (1425)

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

Event Date 10/31/2022

Event Type  malfunction  

Event Description

A customer reported an event of a ¿smell¿ or odor emitting from the sterrad® 100s sterilizer.There was no report of any injuries or human reactions.An asp field service engineer was dispatched to assess the unit onsite.This event is being reported as a malfunction report subsequent to a previous serious injury.

Manufacturer Narrative

A field service engineer was dispatched to the customer site.The oil mist filter was reseated and the vacuum pump oil was replaced, and the reported odor/smells issue was confirmed resolved; however, the customer declined further service and the unit was not returned to specifications as the planned maintenance was overdue.The customer was advised to avoid using the unit until it is in compliance with manufacturer specifications.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).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 odor/smells issue for the sterrad® 100s 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 likely due to the oil mist filter and the vacuum pump oil.The asp field service engineer reseated/replaced the parts and confirmed the odor/smells issue was resolved for the sterrad® 100s.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).

• Brand Name: STERRAD® 100S STERILIZER
• 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: 15830300
• MDR Text Key: 307009189
• Report Number: 2084725-2022-00315
• Device Sequence Number: 1
• Product Code: MLR
• UDI-Device Identifier: 10705037014460
• UDI-Public: 10705037014460
• Combination Product (y/n): N
• Reporter Country Code: CN
• PMA/PMN Number: K991999
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/18/2022

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: 10101
• Device Catalogue Number: 10101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/01/2022
• Initial Date FDA Received: 11/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/04/2011
• 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