MAUDE Adverse Event Report: STERIS CANADA ULC AMSCO 3052 WASHER/DISINFECTOR

Model Number	3052
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/08/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris service technician arrived onsite to inspect the amsco 3052 washer/disinfector and found the unit to be operating properly.No repairs were required.While onsite, the technician was informed that at the time of the reported event the amsco 3052 washer/disinfector was jammed, and the employee was attempting to manually push the rack into the unit.The door then closed and contacted the employee's hand resulting in the reported event.The amsco 3052 washer/ disinfector operator manual states (1-2), "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." "risk of pinch point between door and threshold when the door opens.Keep fingers away from threshold." the technician counseled facility personnel on proper use and operation of the washer, specifically the importance of safe operation protocols detailed in the steris operator manual.No additional issues have been reported.
Event or Problem Description
The user facility reported an employee obtained an injury to their finger while operating their amsco 3052 washer/disinfector.Medical treatment was sought and administered.

• Brand Name: AMSCO 3052 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: 15349253
• Report Number: 9680353-2022-00024
• Device Sequence Number: 5226873
• Product Code: MEC
• UDI-Device Identifier: 00724995193041
• UDI-Public: 00724995193041
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/02/2022

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: 3052
• Device Catalogue Number: FH16072
• 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: 08/08/2022
• Initial Report FDA Received Date: 09/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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