MAUDE Adverse Event Report: STERIS CANADA ULC AMSCO 7052HP WASHER/DISINFECTOR

Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris service technician arrived onsite to inspect the amsco 7052hp washer/disinfector.Upon the technician's arrival, user facility personnel were investigating the source of the leak as they were unsure where the water was coming from.The water was already cleaned up prior to the technician's arrival.The technician found that when a cycle was started a small amount of water leaked around the door seal onto the floor.From further investigation, the technician found that a spray arm tip was missing on the wash arm on the rack which allowed water to spray directly at the door seal causing the reported event.The tip was found on the counter in the decontamination room.Based on the technician's inspection identifying a small leak from the door seal, it is uncertain that the extensive water leak reported by user facility personnel came from the washer.The leak from the door seal is attributed to user error as the employee did not follow proper maintenance instructions for the spray arms as stated in the operator manual.The amsco 7000 series washer/disinfector model 7052hp operator manual states (147), "once a week, inspect and clean chamber rotary spray arm assemblies as follows: g.Reinstall end spray jets on arm assembly using previously removed safety latches.H.Once cleaning procedure is completed, reinstall rotary spray arm assembly to chamber ceiling using previously removed pin." the technician reinstalled the spray arm tip, tested the unit, confirmed it to be operating to specification, and returned it to service.Additionally, the technician counseled the customer on the importance of installing and maintaining the spray arm tips to ensure the water spraying in the appropriate direction and to achieve proper cleaning.No additional issues have been reported.
Event or Problem Description
The user facility reported that they found water under their amsco 7052hp washer/disinfector and the water was leaking onto the floor below.No report of injury.

• Brand Name: AMSCO 7052HP WASHER/DISINFECTOR
• Common Device Name: 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: 17488075
• Report Number: 9680353-2023-00029
• Device Sequence Number: 7872048
• Product Code: MEC
• UDI-Device Identifier: 00724995176594
• UDI-Public: 00724995176594
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 08/09/2023

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: 07/06/2023
• Initial Report FDA Received Date: 08/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/22/2021
• 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