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

Model Number	5052
Medical Device Problem Codes	Mechanical Jam (2983); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	04/04/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation of the subject event is in process.A follow-up mdr will be submitted when additional information becomes available.
Event or Problem Description
The user facility reported that an employee obtained an injury to their hand while operating their amsco 5052 washer.Medical treatment was sought and administered.
Additional Manufacturer Narrative
A steris service technician arrived onsite to inspect the amsco 5052 washer/disinfector and found it to be operating properly.No repairs were required, and the unit was returned to service.The root cause of the reported event is 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/ disinfector operator manual states (1-1), "warning - personal injury hazard: risk of pinch point between door and threshold when the door opens.Keep fingers away from threshold." a steris account manager offered in-service training on the proper use and operation of the amsco 5052 washer/disinfector, specifically, assuring hands and fingers are away from the threshold; however, the user facility declined.No additional issues have been reported.

• Brand Name: AMSCO 5052 WASHER/DISINFECTOR
• Common Device Name: 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: 14518830
• Report Number: 9680353-2022-00018
• Device Sequence Number: 20241138
• Product Code: MEC
• UDI-Device Identifier: 00724995192969
• UDI-Public: 00724995192969
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/26/2022

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
• Operator of Device: Health Professional
• Device Model Number: 5052
• Device Catalogue Number: FH14043
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2022
• Supplement Date Received by Manufacturer: 04/12/2022
• Initial Report FDA Received Date: 05/26/2022
• Supplement Report FDA Received Date: 06/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/12/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown