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

Model Number	10104-002
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter phone number: (b)(6).(b)(4).
Event or Problem Description
A customer reported a cycle cancellation of an e14 atm switch error with their sterrad® 100nx sterilizer and the cancelled cycle was released for use on patients prior to reprocessing.There is no report of infection, injury or harm to patient(s) associated with this issue.Although there is no report of patient injury or harm, advanced sterilization products (asp) has determined in this situation sterility cannot be assured.Therefore, asp has decided to report all incidents of loads that are released from cancelled cycles prior to reprocessing.
Additional Manufacturer Narrative
Upon follow-up with the customer, it was confirmed the load from the cancelled cycle was released but not used on any patients.Therefore, this file is deemed not reportable as there is no risk to patients.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
• MDR Report Key: 11556335
• Report Number: 2084725-2021-00091
• Device Sequence Number: 11813596
• Product Code: MLR
• UDI-Device Identifier: 10705037014507
• UDI-Public: 10705037014507
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/29/2021

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
• Device Lot Number: N/A
• Was the Report Sent to FDA?: Yes
• Initial Date Received by Manufacturer: 02/23/2021
• Supplement Date Received by Manufacturer: 03/23/2021
• Initial Report FDA Received Date: 03/23/2021
• Supplement Report FDA Received Date: 03/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1