MAUDE Adverse Event Report: STERIS CANADA CORPORATION RELIANCE SYNERGY WASHER

Device Problem Smoking (1585)

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

Event Date 08/24/2016

Event Type  No Answer Provided  

Manufacturer Narrative

The user facility reported procedural delays occurred due to the event.A steris service technician inspected the washer and found damage to the electric heating assembly.The electric heating assembly is utilized in the drying phase of the wash cycle.The washer was removed from service.Investigation of this event is currently in process.A follow-up report will be submitted once additional information becomes available.

Event Description

The user facility reported that smoke was observed inside the washer's chamber.No injuries were reported.

Manufacturer Narrative

The unit was installed at the customer's location in october of 2003.Based on the issue reported by the customer and steris engineering analysis, the reported event was caused by the c2 contactor remaining in the activated position.This condition is attributed to high usage of the reliance synergy washer/disinfector which caused sufficient wear of the c2 contactor to exceed its operating life.The contactor is activated several times throughout the duration of a washing cycle.Activation of the contactor may additionally be increased due to various external environmental conditions and settings at the user facility's location.Following the reported event, the user facility was provided with a replacement amsco 5052 washer.No additional issues have been reported.

• Brand Name: RELIANCE SYNERGY 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: 5974052
• MDR Text Key: 55891434
• Report Number: 9680353-2016-00097
• 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,Followup
• Report Date: 09/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2016
• 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?: No
• Date Manufacturer Received: 08/24/2016
• 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
• Patient Outcome(s): Other