MAUDE Adverse Event Report: STERIS CANADA CORPORATION STERIS SYSTEM 1E; LIQUID CHEMICAL STERILANT PROCESSING SYSTEM

Device Problem Insufficient Information (3190)

Patient Problem Burn(s) (1757)

Event Date 07/12/2016

Event Type  No Answer Provided  

Manufacturer Narrative

Despite repeated attempts by the steris district service manager and steris service technician to obtain information regarding the reported event, we have been unable to further investigate this complaint as the user facility has declined to provide additional information regarding the event.A follow-up mdr will be submitted if any additional information is obtained.

Event Description

The user facility reported an employee experienced a burn while operating their system 1e.The employee self-treated with ice; no medical treatment was sought or administered.

Manufacturer Narrative

The steris account manager spoke with user facility personnel regarding the reported event.The user facility stated that at the conclusion of a processing cycle, fluid was identified in the s40 sterilant cup.A user facility employee attempted to dispose of the s40 sterilant cup, and spilled s40 sterilant on her arm.No medical treatment was sought or administered.The user facility stated that the employee subject of the reported event was not wearing proper ppe at the time of the reported event.The steris account manager offered the user facility in-service training on the proper use and operation of both the system 1e and s40 sterilant, however the offer was declined.The system 1e processor operator manual states on page 3-4 "caution: appropriate personal protective equipment (ppe) is required when handling containers of s40 sterilant concentrate.Minimally, ppe should consist of chemical-resistant gloves, apron, goggles or face shield, and any other protection required by facility procedures." the system 1e processor is under contract for steris preventative maintenance services.After the reported event, a steris service technician arrived on-site for the user facility's routine preventative maintenance visit, and identified the aspirator probe required replacement.The technician replaced the aspirator probe on the system 1e processor, tested the unit, and confirmed the unit to be operating according to specification.No additional issues have been noted with the system 1e processor.

• Brand Name: STERIS SYSTEM 1E
• Type of Device: LIQUID CHEMICAL STERILANT PROCESSING SYSTEM
• Manufacturer (Section D): STERIS CANADA CORPORATION; 490 armand-paris; quebec, quebec GIC 8 A3; CA GIC 8A3
• Manufacturer (Section G): STERIS CANADA CORPORATION; 490, armand-paris; quebec, quebec GIC 8 A3; CA GIC 8A3
• Manufacturer Contact: kathryn cadorette ; 5960 heisley road; mentor, OH 44060 ; 4403927231
• MDR Report Key: 5873910
• MDR Text Key: 52060144
• Report Number: 9680353-2016-00077
• Device Sequence Number: 1
• Product Code: MED
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/13/2016
• Was Device Evaluated by Manufacturer?: No
• 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