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

Device Problem Device Fell (4014)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 12/19/2018

Event Type  malfunction  

Manufacturer Narrative

A steris service technician arrived onsite following the reported event to inspect the century sterilizer.The technician was informed that an employee went to open the sterilizer door and the access panel fell open and hit the employee's foot.The access panel is located at the bottom of the sterilizer.The technician inspected the unit and identified that the magnets that hold the panel in place were not aligned properly with the strike plates.The vibration of the door being opened by the employee caused the panel to fall and the reported event to occur.The technician made the necessary repairs, including realigning the magnets and strike plates, and returned the unit to service.This unit was installed in december 2007 and was approximately 11 years old at the time of the reported event.No additional issues have been reported.

Event Description

The user facility reported that the access panel located in the bottom of the century sterilizer fell and hit an employee's foot.No medical treatment was sought or administered.

• Brand Name: CENTURY 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: daniel davy ; 5960 heisley road; mentor, OH 44060 ; 4403927453
• MDR Report Key: 8254421
• MDR Text Key: 133326876
• Report Number: 3005899764-2019-00005
• 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: 01/16/2019

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/19/2018
• Initial Date FDA Received: 01/16/2019
• 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