MAUDE Adverse Event Report: STERIS CANADA CORPORATION AMSCO 5052 WASHER

Device Problem Mechanical Jam (2983)

Patient Problem Injury (2348)

Event Date 11/29/2019

Event Type  malfunction  

Manufacturer Narrative

A steris service technician arrived onsite to inspect the amsco 5052 washer.The technician confirmed that the employee did not fully insert the rack prior to closing the door, resulting in an obstruction.The employee attempted to manually clear the obstruction when the door closed on their finger, resulting in the reported event.The technician confirmed the unit to be operating according to specifications.The root cause of the reported event can be attributed to user error as the employee should not have stuck their hand in the washer as the door was closing.The amsco 5052 washer operator manual states, "warning - personal injury hazard: risk of pinch point between door and threshold when the door opens.Keep fingers away from threshold." the user facility declined the technician's offer for in-service training.No additional issues have been reported.

Event Description

The user facility reported an employee experienced an injury to their finger while attempting to dislodge a rack that had become jammed in their amsco 5052 washer.The employee sought medical treatment.

• Brand Name: AMSCO 5052 WASHER
• Type of Device: WASHER
• Manufacturer (Section D): STERIS CANADA CORPORATION; 490 armand-paris; quebec, GIC 8 A3; CA GIC 8A3
• Manufacturer (Section G): STERIS CANADA CORPORATION; 490, armand-paris; quebec, GIC 8 A3; CA GIC 8A3
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060 ; 4403927453
• MDR Report Key: 9496342
• MDR Text Key: 219764148
• Report Number: 9680353-2019-00054
• 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: 12/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2019
• 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: 11/29/2019
• 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