MAUDE Adverse Event Report: STERIS CANADA CORPORATION AMSCO 5052 WASHER

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Injury (2348)

Event Date 05/02/2016

Event Type  No Answer Provided  

Manufacturer Narrative

A steris service technician inspected the washer and found that the screws that hold the door obstruction bar were not present.Due to the screws missing it caused the obstruction bar to swing down and not stay in place.The technician installed the screws, ran a test cycle and confirmed the washer to be operating properly.No additional issues have been reported.Investigation of this event is currently in process.A follow-up report will be submitted when additional information becomes available.

Event Description

The user facility reported that while an employee was unloading the washer the chamber door came down and contacted his hand.The employee sought and received medical treatment.

Manufacturer Narrative

During the time of the reported event the obstruction bar was not secure.The employee should not have utilized the washer due to the unsecured obstruction bar.In section 4 of the operator manual, a sequence of inspections/operations are to be completed before operating the washer.During these inspections, the employee would have observed the unsecure obstruction bar.The operator manual states (pp.1-1), "repairs and adjustments to this equipment must be made only by steris or steris-trained service personnel.Repairs and adjustments performed by unqualified personnel or installation of unauthorized parts could cause personal injury, result in improper equipment performance, void the warranty or result in costly damage.Contact steris regarding service options." following the reported event a steris service technician arrived onsite to inspect the washer.The technician inspected the washer and found that the screws that hold the obstruction bar were not present.The technician installed the screws, ran a test cycle and confirmed the washer to be operating properly.The washer was returned to service and no additional issues have been reported.

• Brand Name: AMSCO 5052 WASHER
• Type of Device: WASHER
• Manufacturer (Section D): STERIS CANADA CORPORATION; 490 armand-paris; quebec, quebec GIC 8 A3; CA GIC 8A3
• Manufacturer (Section G): STERIS CANADA CORPORATION; 490, armand-paris; quebec, quebec GIC 8 A3; CA GIC 8A3
• Manufacturer Contact: kathryn cadorette ; 5960 heisley road; mentor, OH 44060 ; 4403927231
• MDR Report Key: 5689603
• MDR Text Key: 47334447
• Report Number: 9680353-2016-00057
• 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
• Type of Report: Initial,Followup
• Report Date: 05/31/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2016
• 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?: No
• Date Manufacturer Received: 05/02/2016
• 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