MAUDE Adverse Event Report: STERIS CANADA ULC RELIANCE SYNERGY WASHER/DISINFECTOR

Device Problem Use of Device Problem (1670)

Patient Problem Abrasion (1689)

Event Date 11/10/2022

Event Type  malfunction  

Manufacturer Narrative

A steris service technician inspected the washer and found no issues with the safety bar or sensors.The technician was unable to duplicate the reported event.The employee subject of the reported event did not follow proper operating procedures for the reliance synergy washer/disinfector.The operator manual states, "risk of pinch point between door and threshold when the door opens.Keep fingers away from threshold." the operator manual further states "if an obstruction is present in the chamber door, do not attempt to remove the object." steris will offer in-service training on the proper use and operation for the reliance synergy washer/disinfector.The steris service technician returned the reliance synergy washer/disinfector to service and no additional issues have been reported.

Event Description

The user facility reported that an employee loaded their reliance synergy washer/disinfector and selected the door close button.The units door lowered halfway and stopped.The employee proceeded to push the manifold rack further into the washer/disinfector and the door closed on two of her fingers.The employee sought and received medical treatment.

Manufacturer Narrative

Steris offered in-service training on the proper use and operation for the reliance synergy washer/disinfector.The user facility accepted the offer and steris is scheduled to perform training on (b)(6) 2023.

• Brand Name: RELIANCE SYNERGY WASHER/DISINFECTOR
• Type of Device: WASHER/DISINFECTOR
• Manufacturer (Section D): STERIS CANADA ULC; 490 boulevard armand-paris; quebec, G1C 8 A3; CA G1C 8A3
• Manufacturer (Section G): STERIS CANADA ULC; 490 boulevard armand-paris; quebec, G1C 8 A3; CA G1C 8A3
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060 ; 4403927453
• MDR Report Key: 16147785
• MDR Text Key: 308502038
• Report Number: 9680353-2023-00001
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/13/2022
• 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