MAUDE Adverse Event Report: STERIS CANADA ULC AMSCO 7053HP WASHER/DISINFECTOR

Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Bruise/Contusion (1754)
Date of Event	08/15/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was determined that the employee was attempting to manually clear an obstruction when the door closed on their hand causing the reported event to occur.A steris service technician arrived onsite to inspect the amsco 7053hp washer/disinfector and was not able to duplicate the reported event.No repairs were required, and the unit was returned to service.The amsco 7053hp washer/disinfector operator manual states (pg.87), "if an obstruction is present in the chamber door, do not attempt to remove the object." the amsco 7053hp washer/disinfector operator manual states (pg.13), " warning personal injury and/or equipment damage hazard if an obstruction is present in the wash chamber door, the door safety bar will detect an obstruction and the door will automatically stop from closing.Wait until door is fully open before removing obstruction." the account manager counseled the user facility personnel on the safe operating protocols, specifically door obstruction.No additional issues have been reported.
Event or Problem Description
The user facility reported an employee obtained an injury to their hand while operating their amsco 7053hp washer/disinfector.The employee self-applied an ice pack, took pain medication and returned to work the same day.

• Brand Name: AMSCO 7053HP 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: 17739049
• Report Number: 9680353-2023-00032
• Device Sequence Number: 6876965
• Product Code: MEC
• UDI-Device Identifier: 00724995176655
• UDI-Public: 00724995176655
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 09/13/2023

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
• 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: 08/16/2023
• Initial Report FDA Received Date: 09/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/02/2022
• 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