MAUDE Adverse Event Report: STERIS CANADA CORPORATION RELIANCE 444 WASHER

Device Problem Component Falling (1105)

Patient Problem Injury (2348)

Event Date 04/03/2015

Event Type  No Answer Provided  

Event Description

The user facility reported their reliance 444 washer's top access panel fell from the unit and struck an employee's shoulder when the employee opened the chamber door.The employee attempted to re-secure the panel.The cycle completed, the chamber door was re-opened, and the panel fell a second time.A second employee was startled and twisted an ankle moving out of the way.Both employees sought medical treatment and one employee received advil for the sustained injury.

Manufacturer Narrative

A steris field service technician arrived onsite and was notified the customer had already reinstalled and secured the panel with screws.The technician tested and confirmed the unit to be operating according to specification.The technician was at the facility working on the unit subject of the reported about one week prior to the reported event.The technician removed the panel to gain access to the top portion of the unit and inadvertently neglected to re-secure the panel with the screws.The two employees subject of the reported event returned to normal work duties the same day of the reported event.The steris district service manager has reviewed the reported event with the technician and reiterated the importance of securing the panel on the washer.No additional issues have been reported.

• Brand Name: RELIANCE 444 WASHER
• Type of Device: WASHER
• Manufacturer (Section D): STERIS CANADA CORPORATION; 490 armand-paris; quebec, quebec GIC 8A3; CA GIC 8A3
• Manufacturer (Section G): STERIS CANADA CORPORATION; 490, armand-paris; quebec, quebec GIC 8A3; CA GIC 8A3
• Manufacturer Contact: kathryn cadorette ; 5960 heisley road; mentor, OH 44060 ; 4403927231
• MDR Report Key: 4740950
• MDR Text Key: 19995425
• Report Number: 9680353-2015-00034
• Device Sequence Number: 1
• Product Code: MEC
• 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: Health Professional
• Type of Report: Initial
• Report Date: 04/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2015
• 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: 04/03/2015
• 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