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

Device Problem Obstruction of Flow (2423)

Patient Problem Injury (2348)

Event Date 08/18/2015

Event Type  No Answer Provided  

Manufacturer Narrative

The user facility reported the reliance synergy washer/disinfector had sounded an alarm and the display screen showed a "door obstruction" error.The employee responded to the unit's alarm and found a tray had fallen from inside of the washer creating the door obstruction.The employee then attempted to free the track by pulling forward rapidly on the tray.At this time, the tray was dislodged from the unit and struck the employee in the face.Section 1 of the operator manual for the reliance synergy washer/disinfector states, "always press emergency stop push button prior to removing conveyor and/or chamber obstruction," and "[in] case of an emergency situation involving conveyor modules, always press emergency stop button to stop all washer/disinfector and conveyor operations."while onsite, the steris technician confirmed that the employee subject of the reported event was aware of the proper procedure to power down the unit prior to removing an obstruction.While onsite, the technician inspected the reliance synergy washer, and confirmed the unit was operating according to specification; no repairs or adjustments were required.Steris has offered the user facility in-service training on the proper use and operation of the reliance synergy washer/disinfector.The unit was installed on (b)(6) 2013 and is not under steris contract agreement for maintenance.

Event Description

The user facility reported an employee was injured while trying to remove an obstruction from the reliance synergy washer/disinfector.The employee sought and received medical treatment at the facility's er following the event.

• Brand Name: RELIANCE SYNERGY WASHER/DISINFECTOR
• Type of Device: WASHER/DISINFECTOR
• 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: 5135521
• MDR Text Key: 27825690
• Report Number: 9680353-2015-00063
• 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
• Report Date: 10/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/08/2015
• 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