MAUDE Adverse Event Report: CORPORATION STERIS CANADA AMSCO; CART WASHER/DISINFECTOR

Model Number	7052HP
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	09/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris service technician inspected the amsco 7052hp washer/disinfector and found metal burrs present around the door gasket.The technician filed down the metal burrs, tested the function and operation of the unit, confirmed it to be operating to specifications, and returned it to service.No additional issues have been reported.
Event or Problem Description
The user facility reported that an employee received a cut to their hand while cleaning the door gasket of their amsco 7052hp washer/disinfector.The employee sought and received medical treatment (stitches).

• Brand Name: AMSCO
• Common Device Name: CART WASHER/DISINFECTOR
• Manufacturer (Section D): CORPORATION STERIS CANADA; 490 boulevard armand-paris; quebec, G1C 8 A3; CA G1C 8A3
• Manufacturer (Section G): CORPORATION STERIS CANADA; 490 boulevard armand-paris; quebec, G1C 8 A3; CA G1C 8A3
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060
• MDR Report Key: 20382795
• Report Number: 9680353-2024-00033
• Device Sequence Number: 8066096
• Product Code: MEC
• UDI-Device Identifier: 00724995176594
• UDI-Public: (01)00724995176594(11)220718
• 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): 10/07/2024

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
• Device Model Number: 7052HP
• Device Catalogue Number: FH18043
• 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: 09/09/2024
• Initial Report FDA Received Date: 10/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/18/2022
• 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