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

Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Bruise/Contusion (1754)
Date of Event	08/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that an employee was attempting to remove an obstructed rack from inside the amsco 5052 washer/disinfector chamber, when the door came down and contacted the employees hand.The employee sought and received medical treatment.
Additional Manufacturer Narrative
User facility personnel stated that the employee had retrieved items from the rack and pushed the rack back into the washer's chamber and pressed the "close door" button.The unit then displayed alarm #29 unload door obstruction.The employee observed the alarm and proceeded to resolve the obstruction subsequently causing the washer door to come down and contact her hand.A steris service technician inspected the amsco 5052 washer/disinfector and found no issues with the function or operation of the unit.No service repairs were required and the amsco 5052 washer/disinfector was returned to service.The operator manual states, "personal injury and/or equipment damage hazard: "if an obstruction is present in the wash chamber door, door safety bar will detect obstruction and door will automatically stop from closing.Wait until door is fully open before removing obstruction" and "if an obstruction occurs and that the chamber door is not fully open, press emergency stop pushbutton prior to removing obstruction." during the steris technician's inspection of the amsco 5052 washer/disinfector, it was found that the unit had displayed "door safety test required" earlier in the week prior to the reported event.User facility personnel did not perform the door safety test and proceeded to utilize the unit.Following the reported event and the steris service technician's inspection, the user facility's biomed performed the door safety test and confirmed the unit to be operational.The steris service technician counseled user facility personnel on the importance of following safety operating procedures and routine maintenance.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 rd; mentor, OH 44060 ; 4403927453
• MDR Report Key: 17747174
• Report Number: 9680353-2023-00034
• Device Sequence Number: 14866370
• Product Code: MEC
• UDI-Device Identifier: 00724995192976
• UDI-Public: 00724995192976
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 09/14/2023

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: 09/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/17/2018
• 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