MAUDE Adverse Event Report: STERIS CANADA ULC AMSCO 5052 WASHER/DISINFECTOR

Device Problem Mechanical Jam (2983)

Patient Problem Pain (1994)

Event Date 05/25/2022

Event Type  malfunction  

Manufacturer Narrative

A steris service technician arrived on site to inspect the unit.The technician found the unit to be operating properly, no repairs were required, and the washer was returned to service.The reported event is attributed to user error as the employee should have pressed the emergency stop pushbutton prior to removing the obstruction.The amsco 5052 washer operator manual states (1-1), "warning - personal injury and/or equipment damage hazard: if an obstruction occurs and that the chamber door is not fully open, press emergency stop pushbutton prior to removing obstruction." the operator manual further states (1-1), "warning - personal injury hazard: risk of pinch point between door and upper panel.Do not push on top portion of doors; do not push on door when door is rising; do not push on door when door is jammed." the customer was counseled on safe operating protocols and the spd technician was aware of the use of the emergency stop and to not free door obstruction manually.No additional issues have been reported.

Event Description

The user facility reported an obstruction in the amsco 5052 washer door which caused a rack to jam.The spd technician attempted to push the rack back into the washer.When the rack pushed through, the door closed, and the hand of spd technician got stuck between door and frame.The spd technician sought medical treatment.It was found that spd technician obtained a sprain and was given a soft hand splint to wear.

• Brand Name: AMSCO 5052 WASHER/DISINFECTOR
• Type of Device: WASHER/DISINFECTOR
• Manufacturer (Section D): STERIS CANADA ULC; 490 boulevard armand-paris; quebec, G1C 8 A3; CA G1C 8A3
• Manufacturer (Section G): STERIS CANADA ULC; 490 boulevard armand-paris; quebec, G1C 8 A3; CA G1C 8A3
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060 ; 4403927453
• MDR Report Key: 14776689
• MDR Text Key: 303236685
• Report Number: 9680353-2022-00019
• 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: 06/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 05/27/2022
• Initial Date FDA Received: 06/22/2022
• 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