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

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Injury (2348)

Event Date 11/24/2014

Event Type  No Answer Provided  

Event Description

The user facility reported an employee was dislodging a rack inside the washer when the washer's door closed on the employee's hand.The employee went to the er and was administered medical treatment for a deep cut.No report of procedural delays or cancellations.

Manufacturer Narrative

A steris field service technician arrived onsite, inspected the unit, and confirmed the unit to be operating according to specification and was unable to duplicate the reported event.The operator manual states, "if an obstruction is present in chamber door, do not attempt to remove the object," and "warning - personal injury hazard: risk of pinch point between door and threshold when door opens.Keep fingers away from threshold." steris has offered in-service training (including door obstruction procedure), but the user facility has not yet confirmed a date for training.

Manufacturer Narrative

In-service has been performed with the user facility and no additional issues have been reported.

• 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: 4356409
• MDR Text Key: 5221001
• Report Number: 9680353-2014-00096
• 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: 12/23/2014

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: 12/09/2014
• Initial Date FDA Received: 12/23/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/09/2015
• 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