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

Device Problem Device Fell (4014)

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

Event Date 09/10/2019

Event Type  malfunction  

Manufacturer Narrative

While onsite, the technician inspected the sterilizer and found that the top panel was missing the bolts that secure the panel in place.The technician secured the panel in place, tested the unit, confirmed it to be operating according to specification, and returned it to service.The unit was installed at the user facility in september 2019 by a third-party service provider.At the time of installation, the third-party service provider did not install the bolts for the top panel.A steris installation project manager has re-trained the third-party service provider on proper installation of the evolution sterilizer.No additional issues have been reported.

Event Description

The user facility reported that while a steris service technician was onsite for service the top panel on their evolution sterilizer fell off the unit.The panel was caught by the technician and a user facility employee.There were no injuries associated with the reported event.

• Brand Name: 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, 67190 ; MX 67190
• Manufacturer (Section G): STERIS MEXICO, S. DE R.L. DE C.V.; avenida avante 790; parque industrial guadalupe; guadalupe, 67190 ; MX 67190
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060 ; 4403927453
• MDR Report Key: 9172308
• MDR Text Key: 199550660
• Report Number: 3005899764-2019-00084
• 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: 10/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2019
• 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: 09/10/2019
• 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