MAUDE Adverse Event Report: STERIS CANADA CORPORATION RELIANCE VISION MULTI-CHAMBER WASHER

Device Problem Device Slipped (1584)

Patient Problem No Code Available (3191)

Event Date 07/12/2016

Event Type  No Answer Provided  

Manufacturer Narrative

No report of injury or procedural delays or cancellations.A steris service technician inspected the reliance vision multi-chamber washer and confirmed the component to be loose was the obstruction door bar.The technician repaired the obstruction door bar, ran a test cycle and confirmed the washer to be operating properly.

Event Description

The user facility reported that a component of the reliance vision multi-chamber washer door was loose and not operating properly.

• Brand Name: RELIANCE VISION MULTI-CHAMBER 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: kathryn cadorette ; 5960 heisley road; mentor, OH 44060 ; 4403927231
• MDR Report Key: 5869494
• MDR Text Key: 52736257
• Report Number: 9680353-2016-00076
• 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: Other
• Type of Report: Initial
• Report Date: 08/11/2016

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
• Initial Date Manufacturer Received: 07/12/2016
• Initial Date FDA Received: 08/11/2016
• 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