MAUDE Adverse Event Report: STERIS CANADA CORPORATION RELIANCE 444 WASHER

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Injury (2348)

Event Date 08/07/2017

Event Type  malfunction  

Manufacturer Narrative

The user facility stated the washer door began to close on the employee subject of the reported event's hand as she was removing a load from the washer.The door contacted the employee's hand and she quickly removed her hand from the area, no pinch point occurred.The employee subject of the reported event sought medical treatment at the user facility er, however no treatment was received.A steris service technician arrived on-site, inspected the washer, and identified the door proximity sensor required replacement.The technician replaced the door proximity sensor, tested the unit, and confirmed it to be operating according to specification.The reliance 444 washer was installed at the user facility in 2001 and has been in service for over 15 years.No additional issues have been reported.

Event Description

The user facility reported the door on their reliance 444 washer closed on an employee's hand.No procedure delay or cancellation occurred as a result.

• Brand Name: RELIANCE 444 WASHER
• Type of Device: WASHER
• Manufacturer (Section D): STERIS CANADA CORPORATION; 490 armand-paris; quebec, quebec GIC 8 A3; CA GIC 8A3
• Manufacturer (Section G): STERIS CANADA CORPORATION; 490, armand-paris; quebec, quebec GIC 8 A3; CA GIC 8A3
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060 ; 4403927453
• MDR Report Key: 6845825
• MDR Text Key: 85620440
• Report Number: 9680353-2017-00062
• Device Sequence Number: 1
• Product Code: MEC
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/07/2017
• 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