MAUDE Adverse Event Report: STERIS CANADA CORPORATION RELIANCE VISION SINGLE CHAMBER WASHER

Device Problems Device Operates Differently Than Expected (2913); Difficult to Open or Close (2921)

Patient Problem Injury (2348)

Event Date 12/11/2013

Event Type  No Answer Provided  

Event Description

The user facility reported an employee pressed the door close button on the washer and walked away from the unit.Several moments later, the employee observed the door had not closed.The employee stated the unit was not in any alarm, however, the unit's display screen showed a "door not closed" prompt.The employee used his hand in an attempt to close the unit's door.The employee stated the door then came down onto his hand at a rapid pace pinching his middle two fingers between the door and the unit's frame.Multiple coworkers assisted the employee in freeing his hand from the unit by prying open the door with a long bar.No procedural delays/cancellations were reported.

Manufacturer Narrative

The injured employee required 3 stitches on his middle finger, 1 stitch on his ring finger and was sent home for the remainder of the day.The employee has since confirmed that the stitches were removed and he has returned to work with full work duties.The employee stated that at the time of the event, he was wearing the required facility ppe including latex gloves.A steris service technician arrived at the facility to inspect the washer and found the door was unable to operate normally due to a door sensor mounting plate which was bent.The bent mounting plate was caused after the reported event when the facility pried the door open to remove the employee's hand.The technician removed the bent mounting place and tested all other door functions.The steris technician found that with the mounting plate removed, the door functioned properly.The steris technician then tested the unit's door obstruction sensors and found the sensors were operating to specification.Contrary to the employee's report that the unit did not alarm, a "load door did not close" prompt on the display screen is an alarm as noted in the unit's operator manual.This alarm is generated when the door close time exceeds 12 seconds and appears in a red color on the display screen.Steris has requested the cycle printouts from the day of the reported event in order to gather more information.The reliance vision operator manual states, "warning-personal injury hazard: do not push on top portion of doors; do not push on door when door is rising; do not push on door when door is jammed." the injured employee has been retrained on proper use and operation of the reliance vision single chamber washer.The investigation of this event is currently in process, a follow-up report will be submitted once additional information becomes available.

• Brand Name: RELIANCE VISION SINGLE CHAMBER WASHER
• Type of Device: WASHER
• Manufacturer (Section D): STERIS CANADA CORPORATION; 490 armand-paris; quebec, quebec GIC 8A3; CA GIC 8A3
• Manufacturer (Section G): STERIS CANADA CORPORATION; 490, armand-paris; quebec, quebec GIC 8A3; CA GIC 8A3
• Manufacturer Contact: kathryn cadorette ; 5960 heisley road; mentor, OH 44060 ; 4403927231
• MDR Report Key: 3568679
• MDR Text Key: 4050865
• Report Number: 9680353-2014-00006
• 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: 01/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: Yes
• Initial Date Manufacturer Received: 12/13/2013
• Initial Date FDA Received: 01/10/2014
• 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