MAUDE Adverse Event Report: STERIS CANADA CORPORATION 220 CART WASHER

Device Problem Bent (1059)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/30/2014

Event Type  No Answer Provided  

Event Description

The user facility reported their cart washer has a bent piece of metal exposed which could create a safety hazard for employees.No report of injuries.

Manufacturer Narrative

A steris field service technician arrived onsite, inspected the unit, and identified the metal edge was on the double door's vertical center support.The technician determined this piece of sheet metal had bent over time due to impact damage from the loading carts.This type of damage is indicative of the carts being forcibly placed in the unit and contacting the door support creating an edge.The technician repaired and resecured the sheet metal to prevent a reoccurrence of an edge formation.The operator manual states, "wear appropriate personal protective equipment (ppe) whenever reaching into or entering wash chamber.".

• Brand Name: 220 CART 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: 4467160
• MDR Text Key: 5181332
• Report Number: 9680353-2015-00011
• 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: 01/29/2015

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: 12/30/2014
• Initial Date FDA Received: 01/29/2015
• 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
• Patient Outcome(s): Other