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

Device Problems Improper or Incorrect Procedure or Method (2017); Device Tipped Over (2589)

Patient Problem Sprain (2083)

Event Date 06/07/2014

Event Type  No Answer Provided  

Event Description

The user facility reported that an employee was injured while assisting steris technicians with the installation of a new reliance vision single chamber washer.Steris installers were transporting the washer into the department on a flatbed cart and when attempting to tilt the unit upright the cart slipped out from under the washer.A facility employee offered her assistance in holding the cart steady and reportedly felt a strain in her back.The employee did not seek any type of medical attention and did not take time off of work due to the injury.Following the event, the employee used over the counter ibuprofen for pain management and has since reported she is no longer experiencing any soreness.A procedural delay was reported as installation of the washer was delayed due to the event.

Manufacturer Narrative

During installation of a new reliance vision single chamber washer, steris installers experienced difficulty while transporting the washer from the flatbed cart into the sterile processing department.While attempting to tilt the washer upright off of the cart, the washer fell approximately 18 inches to the floor.Due to the visible damage sustained to the washer during installation, steris is providing a new washer to the user facility.The steris installers will be provided with re-training on the proper procedures for capital equipment installation.

• Brand Name: RELIANCE VISION SINGLE CHAMBER WASHER/DISINFECTOR
• Type of Device: WASHER
• Manufacturer (Section D): STERIS CANADA CORPORATION; 490, armand-paris; quebec GIC 8A3; CA GIC 8A3
• Manufacturer (Section G): STERIS CANADA CORPORATION; 490, armand-paris; quebec GIC 8A3; CA GIC 8A3
• Manufacturer Contact: kathryn cadorette ; 5960 heisley rd.; mentor, OH 44060 ; 4403927231
• MDR Report Key: 3983580
• MDR Text Key: 4886346
• Report Number: 9680353-2014-00046
• 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: 07/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2014
• 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: 06/07/2014
• 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
• Patient Outcome(s): Other