MAUDE Adverse Event Report: ADVANCED STERILIZATION PRODUCTS STERRAD 100NX STERILIZER; STERRAD EQUIPMENT (MLR)

Catalog Number 10104

Device Problem Device Disinfection Or Sterilization Issue (2909)

Patient Problem No Patient Involvement (2645)

Event Date 02/23/2017

Event Type  malfunction  

Manufacturer Narrative

Brand name - the correct brand name is sterrad 100nx sterilizer.Common device - the correct common device is sterrad equipment.Catalog number - the correct catalog number is 10104-003.Serial number - the correct serial number is (b)(4).

Event Description

A customer reported encountering an issue of suspect positive biological indicator after a completed sterrad®100nx express cycle.It was additionally reported that the customer self identified user error as one of the employees had processed the scopes on the top shelf versus the bottom shelf on an express cycle.The affected scopes were reprocessed and there was no report of injury or harm to patient(s) associated with this issue.Although there is no report of any serious patient injury or harm and no prior incidents have resulted in serious injury, advanced sterilization products (asp) has determined in this situation sterility cannot be assured.Therefore, as a matter of policy asp had decided to report all incidents of loads processed on the top shelf of the sterrad® 100nx sterilizer during an express cycle.

Manufacturer Narrative

Asp investigation summary: the investigation included a review of the device batch record and system risk analysis (sra).Dhr was reviewed and unit was confirmed to have met all process specifications before release of product.The sra review indicates the risk associated with a ¿quality problem with no impact on safety¿, is considered to be ¿low¿.Service for the unit was not required for the reported issue, as such, a field service engineer was not dispatched to evaluate the unit.The assignable cause of the reported issue was user error since the customer processed the load on the incorrect shelf for the express cycle.The customer self-identified the processing issue and self corrected, therefore, no additional training/education is needed.The issue will continue to be tracked and trended.

• Brand Name: STERRAD 100NX STERILIZER
• Type of Device: STERRAD EQUIPMENT (MLR)
• 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: joaquin kurz ; irvine, CA 92618 ; 9497893837
• MDR Report Key: 6415373
• MDR Text Key: 70315441
• Report Number: 2084725-2017-00141
• Device Sequence Number: 1
• Product Code: MLR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071385
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 10104
• Device Lot Number: 1043140279
• Other Device ID Number: 10104
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/01/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2014
• 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