MAUDE Adverse Event Report: ADVANCED STERILIZATION PRODUCTS EVOTECH ECR 208V; EVOTECH¿ EQUIPMENT

Model Number	50004
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Appropriate term/code not available- load not recalled.Asp complaint ref #: (b)(4).
Event or Problem Description
A customer reported a cycle cancellation of an a.10.3 overflow or system leak with their evotech¿ ecr 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 high level disinfection 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
H3: asp investigation summary: the investigation included a review of the device history record (dhr), trending analysis of the load not recalled issue, and system risk analysis (sra).The dhr was reviewed and no issues relating the failure mode were noted.The involved unit met manufacturer specifications at the time of release.Trending analysis of the load not recalled issue for the evotech¿ ecr unit was reviewed for the prior six months from open date and no significant trend was observed.The sra shows the risk for exposure to biohazardous, pathogenic or infectious material to be "low." the issue has been attributed to user error as the load from the cancelled cycle was released for use on patients prior to reprocessing.A customer letter was sent instructing the customer to review the user¿s guide which states that loads from cancelled cycles should be reprocessed.Asp will continue to track and trend this issue.Asp complaint ref #: (b)(4).

• Brand Name: EVOTECH ECR 208V
• Common Device Name: EVOTECH¿ EQUIPMENT
• Manufacturer (Section D): ADVANCED STERILIZATION PRODUCTS; 33 technology drive; irvine CA 92618
• MDR Report Key: 11620164
• Report Number: 2084725-2021-00090
• Device Sequence Number: 2999023
• Product Code: FEB
• UDI-Device Identifier: 10705037030958
• UDI-Public: 10705037030958
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K040883
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2021

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: 50004
• Device Catalogue Number: 50004
• Device Lot Number: N/A
• Was the Report Sent to FDA?: Yes
• Initial Date Received by Manufacturer: 03/15/2021
• Supplement Date Received by Manufacturer: 05/18/2021
• Initial Report FDA Received Date: 04/06/2021
• Supplement Report FDA Received Date: 05/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1