MAUDE Adverse Event Report: STERIS CANADA ULC AMSCO 7052HP WASHER/DISINFECTOR

Device Problem Mechanical Jam (2983)

Patient Problem Damage to Ligament(s) (1952)

Event Date 01/31/2024

Event Type  malfunction  

Manufacturer Narrative

The steris technician learned from facility personnel that the door was jammed on an instrument sticking out of the rack and the unit alarmed load door obstruction.The employee attempted to manually clear the obstruction allowing the washer door to close on their hand.The steris technician inspected the washer and found it to be operating per specifications.No repairs were required and the unit was returned to service.Steris operator manual states with general loading guidelines: "ensure no items stick out or hang out of rack.Always use a rack designed to handle appropriate items being processed.".Steris operator manual states with personal injury hazard: "if it ever occurs that the sensor does not detect a door obstruction, never use your hand to push on the obstruction trying to dislodge it.Call steris for this abnormal situation.".Root cause to the event is likely attributed to user error.The steris service technician counseled employee on proper loading techniques and safety operation protocols.No additional issues have been reported.

Event Description

The user facility reported that an employee injured their finger while manually clearing a door obstruction to a amsco 7052 washer.The user facility disclosed that medical treatment was sought and administered to injured employee.

• Brand Name: AMSCO 7052HP 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 rd; mentor, OH 44060 ; 4403927453
• MDR Report Key: 18818282
• MDR Text Key: 337658034
• Report Number: 9680353-2024-00011
• 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: 03/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2024
• 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: 02/02/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/18/2021
• 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