MAUDE Adverse Event Report: STERIS MEXICO, S. DE R.L. DE C.V. 36" EVOLUTION STERILIZER

Device Problem Detachment Of Device Component (1104)

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

Event Date 06/07/2016

Event Type  No Answer Provided  

Manufacturer Narrative

A steris service technician inspected the unit and identified that the door, and door connection points on the unit, had become corroded.During the evaluation of the unit, the technician determined that steam was entering the door assembly resulting in damage to the components that secure the door to the sterilizer.The sterilizer is 34 years old and is not maintained by steris.The root cause of the reported event is improper maintenance of the unit which caused the reported damage and corrosion of the door assembly.The user facility reported the sterilizer will not be replaced as the facility is closing and will move to a new location.

Event Description

The user facility reported that the door of their 36" evolution sterilizer came off during a processing cycle.No injury, procedural delay or cancellation was reported.

• Brand Name: 36" 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: 5776065
• MDR Text Key: 49766906
• Report Number: 3005899764-2016-00049
• 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,Followup
• Report Date: 07/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/08/2016
• 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