MAUDE Adverse Event Report: STERIS CANADA CORPORATION RELIANCE SYNERGY WASHER

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Information (3190)

Event Date 05/15/2017

Event Type  malfunction  

Manufacturer Narrative

No medical treatment was sought or administered.A steris service technician arrived onsite to inspect the washer and found the unit to be operating properly; no issues were noted.The technician also confirmed that the safety bar was operating properly; no issues were noted.The employee subject of the reported event did not follow the proper operating procedure for removing an obstruction as stated in the reliance synergy washer's operator manual.The operator manual states (pp.1-1), "if an obstruction is present in the wash chamber door, door safety bar will detect obstruction and door will automatically stop from closing.Wait until door is fully open and water flow has stopped before removing obstruction." steris offered in-service training on the proper use and operation of the washer; the user facility accepted the offer of in-service training.The washer was manufactured in 2009 and is serviced and maintained by the user facility.

Event Description

The user facility reported that an employee manually forced an instrument manifold rack into the washer to release the obstruction and in the process the door contacted their hand.

• 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: lyndsey snyder ; 5960 heisley road; mentor, OH 44060 ; 4403927386
• MDR Report Key: 6644887
• MDR Text Key: 77766833
• Report Number: 9680353-2017-00048
• Device Sequence Number: 1
• Product Code: MEC
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 06/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 05/18/2017
• Initial Date FDA Received: 06/15/2017
• 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