MAUDE Adverse Event Report: STERIS CANADA CORPORATION RELIANCE VISION SINGLE CHAMBER WASHER/DISINFECTOR

Device Problems Component Falling (1105); Entrapment of Device (1212); Sticking (1597)

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

Event Date 06/09/2015

Event Type  No Answer Provided  

Event Description

The user facility reported that a loaded rack was stuck between their reliance vision single chamber washer\disinfector and the motorized feed-in conveyor.An employee attempted to move the loaded rack out of the chamber when the washer door came down on the employee's arm.

Manufacturer Narrative

A steris field service technician arrived onsite, inspected the unit and conveyor, and noted the scs conveyor was pushing racks into the washer slightly sideways.It was further observed the scs conveyor's automated wheels were continually rotating toward the washer.The technician observed that the scs conveyor's feet were misaligned.Additionally, he observed that the sensor was not properly aligned.The technician adjusted the proximity sensor on the load table.The technician leveled the feet of the scs conveyor, tested the unit, and confirmed it to be operating according to specification.The dsm will review proper installation techniques with the steris technician who installed the unit.Section 1: safety precautions of the reliance vision single chamber washer\disinfector operator manual states, "if an obstruction is present in chamber door, do not attempt to remove the object." section 1: safety precautions of the scs conveyor operator manual states, "risk of pinch point between door and threshold when the door opens.Keep fingers away from threshold." steris offered in-service training regarding proper operation of the conveyor and washer but the customer has declined.

• Brand Name: RELIANCE VISION SINGLE CHAMBER WASHER/DISINFECTOR
• 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: 4899564
• MDR Text Key: 6022246
• Report Number: 9680353-2015-00040
• 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: 07/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2015
• 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: 06/10/2015
• 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