MAUDE Adverse Event Report: STERIS MEXICO, S. DE R.L. DE C.V. 42" EVOLUTION STERILIZER

Device Problem Moisture or Humidity Problem (2986)

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

Event Date 02/09/2016

Event Type  No Answer Provided  

Manufacturer Narrative

A steris service technician visited the facility following the event and found the facility has 3 units, including the evolution sterilizer, which connect to the floor drain.The standing water is attributed to an inadequate floor drain which could not accommodate the multiple units.The user facility has been made aware of their drain issues and is in the process of installing a new drain to meet the requirements of all three units.Steris was additionally informed that an employee received a "static shock" while standing in the puddle of water and touching a piece of equipment in the room.The employee did not seek medical treatment and resumed normal work duties.While onsite, the steris technician confirmed the steris evolution sterilizer was correctly grounded and was operating according to specification.The customer believes the employee subject of the report event received a shock from normal static electricity and not from an electrical issue with the sterilizers.

Event Description

The user facility reported standing water was discovered near the facility's floor drain, which connects to the evolution sterilizer.

• Brand Name: 42" EVOLUTION STERILIZER
• Type of Device: STERILIZER
• Manufacturer (Section D): STERIS MEXICO, S. DE R.L. DE C.V.; avenida avante 790; parque industrial guadalupe; guadalupe, nuevo leon 67190 ; MX 67190
• Manufacturer (Section G): STERIS MEXICO, S. DE R.L. DE C.V.; avenida avante 790; parque industrial guadalupe; guadalupe, nuevo leon 67190 ; MX 67190
• Manufacturer Contact: kathryn cadorette ; 5960 heisley road; mentor, OH 44060 ; 4403927231
• MDR Report Key: 5489417
• MDR Text Key: 39981102
• Report Number: 3005899764-2016-00018
• Device Sequence Number: 1
• Product Code: FLE
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 03/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/09/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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