MAUDE Adverse Event Report: STERIS MEXICO, S. DE R.L. DE C.V. AMSCO 400 STERILIZER

Device Problems Detachment Of Device Component (1104); Component Falling (1105)

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

Event Date 05/20/2015

Event Type  No Answer Provided  

Event Description

The user facility reported a rack fell from their amsco 400 sterilizer's transfer cart.Instruments fell off of the rack near an employee but did not hit or make contact with the employee.No report of injury or procedural delay or cancellation.

Manufacturer Narrative

A steris field service technician arrived onsite, inspected the sterilizer and docking station, and was unable to identify any issues.All locking mechanisms and springs were present and operational.The technician tested the unit and confirmed it to be operating according to specification and instruments were reprocessed after the reported event.It is likely the rack was not properly secured onto the loading cart.When the employee moved the loading cart, the instruments fell from the rack.Section 6: sterilizer operation: states, "open chamber door, remove load from chamber, slide shelves into chamber, verifying that position does not interfere with door operation, close chamber doors, transfer load to destination." steris offered in-service training on the proper use and operation of the sterilizer and transfer cart and the user facility accepted.The unit was installed on 9/25/2014 and is not under steris contract agreement for maintenance.

• Brand Name: AMSCO 400 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 6719 0; MX 67190
• Manufacturer (Section G): STERIS MEXICO, S. DE R.L. DE C.V.; avenida avante 790; parque industrial guadalupe; guadalupe, nuevo leon 6719 0; MX 67190
• Manufacturer Contact: kathryn cadorette ; 5960 heisley road; mentor, OH 44060 ; 4403927231
• MDR Report Key: 4835928
• MDR Text Key: 5914711
• Report Number: 3005899764-2015-00043
• 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: 06/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2015
• 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: 05/20/2015
• 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
• Patient Outcome(s): Other