MAUDE Adverse Event Report: STERIS CANADA ULC AMSCO 1215 CART & UTENSIL WASHER/DISINFECTOR

Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Bruise/Contusion (1754)
Date of Event	04/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
During the steris service technician's follow up with user facility personnel, it was stated that the employee subject of the reported event had placed a container lid on top of the universal rack.The container lid was pointing outward and hit the top panel when the employee pushed the rack into the amsco 1215 cart & utensil washer/disinfector subsequently causing the reported event to occur.User facility personnel stated to the steris service technician that the top panel had not been secured with mounting screws at the time of the reported event.The steris service technician's inspection of the amsco 1215 cart & utensil washer/disinfector confirmed that the mounting screws were present however, the screws may have been loose at the time of the event subsequently causing the panel to lift and fall when the container lid struck the panel from the bottom when the employee was loading the rack into the unit.The steris service technician reinstalled the panel, confirmed the mounting screws were properly tightened, tested the unit, and returned the amsco 1215 cart & utensil washer/disinfector to service.The steris service technician counseled user facility personnel of the proper loading techniques and ensuring no items are sticking out of the rack.The operator manual states (section 4.5), "when loading universal rack, ensure no items stick out of rack." no additional issues have been reported.
Event or Problem Description
The user facility reported that while an employee was loading their amsco 1215 cart & utensil washer/disinfector, the top panel fell off and hit the employee in the forehead.The employee sought and received medical treatment and returned to work.

• Brand Name: AMSCO 1215 CART & UTENSIL 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 rd; mentor, OH 44060 ; 4403927453
• MDR Report Key: 19280299
• Report Number: 9680353-2024-00015
• Device Sequence Number: 6320846
• Product Code: MEC
• UDI-Device Identifier: 00724995214401
• UDI-Public: 00724995214401
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 05/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• 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: 04/09/2024
• Initial Report FDA Received Date: 05/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/29/2024
• 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