MAUDE Adverse Event Report: STERIS CANADA CORPORATION 1227 CART WASHER

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Injury (2348)

Event Date 06/05/2015

Event Type  No Answer Provided  

Event Description

The user facility reported via medwatch (b)(4) that employees are sustaining hand injuries when removing carts from the cart washer.

Manufacturer Narrative

The user facility medwatch also stated that employee's hands are getting caught between the cart and door when unloading.No handles are attached.A steris service technician inspected the washer and case cart and found them to be operating properly.No issues were noted.The washer and case cart were returned to service and no additional issues have been reported.Contrary to the facility report, the technician confirmed the case cart's handles were attached to the unit.Instead of utilizing the case cart handles the employee grabbed the top left and right side of the cart to remove it from the washer.In the process of removing the case cart the employee injured her finger between the washer door and case cart.The employee wore a soft brace and missed no time from work.The user facility reported that employees were sustaining injuries, however steris was made aware of only one employee injury in relation to the reported event.Handles on the case cart are located on one side of the case.The handles on the case cart should be facing the unload side for proper unloading after a washing cycle.The user facility could not confirm the position of the case cart at the time of the reported event and therefore it is possible the employee could not see the handles to ensure proper removal.The employee who sustained the injury was new to the department.Steris performed in-service training on the proper use and handling of the case cart and washer.The case cart subject of the reported event is not serviced or maintained by steris.

• Brand Name: 1227 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: 4918604
• MDR Text Key: 6050605
• Report Number: 9680353-2015-00044
• Device Sequence Number: 1
• Product Code: FLH
• 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: Health Professional
• Type of Report: Initial
• Report Date: 07/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/22/2015
• 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