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

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Abrasion (1689)

Event Date 07/25/2021

Event Type  malfunction  

Manufacturer Narrative

A steris service technician arrived onsite to inspect the reliance synergy washer/disinfector and it was found to be operating properly; no repairs were required.While onsite, the technician learned that when the employee opened their washer door to unload the washer, the employee noticed that the door would not raise and appeared to be caught on an item that was protruding from the overloaded rack.As the door would not open, the employee manually cleared the obstruction resulting in the reported event.The reported event is attributed to user error as the employee should not have placed their hand into the washer and should have utilized the emergency stop button.The reliance synergy washer/disinfector operator manual states (1-1), "warning - personal injury hazard: in case of an emergency situation involving the conveyor modules, always press emergency stop button to stop all washer/disinfector and conveyor operations." a steris account manager performed an in-service training on 7/29/2021 on the importance of utilizing the emergency stop button when removing an obstruction from the washer chamber.No additional issues have been reported.

Event Description

The user facility reported that an employee injured their hand while unloading an overloaded rack from their reliance synergy washer/disinfector.Medical treatment was sought; however, user facility personnel did not disclose if medical treatment was administered.

• 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: 12359609
• MDR Text Key: 267872595
• Report Number: 9680353-2021-00033
• 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
• Report Date: 08/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2021
• 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: 07/25/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/06/2005
• 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