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

Model Number 10113

Device Problem Expiration Date Error (2528)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/24/2020

Event Type  malfunction  

Manufacturer Narrative

Asp complaint ref #: (b)(4).

Event Description

A customer reported an expired cassette was used with their sterrad® 100s sterilizer and three cycles were run and released for use.The sterrad® 100s sterilizer had not been in use since (b)(6) 2019.On (b)(6) 24, 2020, the sterrad® 100s was powered back on due to another sterilizer that was not operating.The customer stated that after the last of the three cycles were run and while removing the cassette from the sterilizer, the customer noticed the use by date on the cassette was (b)(6) 2019 and was expired.The cassette had been sitting in the sterrad since october when it was last used and did not eject from the sterrad prior to use.All items in the loads were then recalled and reprocessed except two items, a rigid telescope and a camera and light lead which had been released and used on patients.The customer stated they had used a biological with the released load and the biological test result was negative and passed.There was no report of infection, injury or harm to patient(s) associated with this issue.Although there is no report of 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 when a customer uses expired product and when the load has been released and used on patient(s) prior to reprocessing.

Manufacturer Narrative

Asp investigation summary: the investigation included a review of the device batch record, trending analysis by lot number, and system risk analysis (sra).The batch record review did not reveal any indication on a deviating quality profile for this batch.No quality issues were reported.All in-process controls corresponded to the specification.Trending analysis by lot number for the issue of use of expired product - confirmed load not recalled was reviewed within the past year and trending was not exceeded.The sra indicates the risk associated with exposure to toxic or corrosive material is "low." the cassette was not returned for evaluation.An issue with the concomitant sterrad sterilizer is unlikely as review of the cycle printouts.Confirmed the parameters were all within an acceptable range.In addition, the field service engineer (fse) attempted to insert an expired cassette into the sterilizer, but the sterrad did not accept it.It this confirmed the sterrad is working as per specification.The assignable cause of the reported issue could not be verified as the product was not returned for evaluation and was expired.In addition, the sterrad is designed to not accept an expired cassette and to eject expired cassettes.During further field testing after the reported incident the sterrad did behave as per specifications.Batch record review found no anomalies that would contribute to the issue and lot history review did not exceed trending.The issue will continue to be tracked and trended.Asp complaint ref #: (b)(4).

• Brand Name: STERRAD 100S CASSETTE
• Type of Device: STERRAD EQUIPMENT
• Manufacturer (Section D): ADVANCED STERILIZATION PRODUCTS; 33 technology drive; irvine CA 92618
• MDR Report Key: 9696121
• MDR Text Key: 185499891
• Report Number: 2084725-2020-00011
• Device Sequence Number: 1
• Product Code: MLR
• UDI-Device Identifier: 10705037014583
• UDI-Public: 10705037014583
• Combination Product (y/n): N
• PMA/PMN Number: K991999
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2019
• Device Model Number: 10113
• Device Catalogue Number: 10113
• Device Lot Number: 18L019
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1