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

Model Number	1215
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Headache (1880); Swelling/ Edema (4577)
Date of Event	03/05/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris service technician arrived onsite to inspect the amsco 1215 cart & utensil washer/disinfector and found the screws were loose that secure the panel to the unit.To resolve the issue, the technician re-installed the top panel and confirmed the screws were properly tightened.The technician tested the function and operation of the amsco 1215 cart & utensil washer/disinfector, confirmed it to be operating to specifications, and returned it to service.The device history record was reviewed and confirmed the unit was manufactured to specification; no abnormalities were noted.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 and contacted the employee's head.The employee sought medical treatment and received a ct scan which confirmed no further injuries or medical treatment required.The employee returned to work.

• Brand Name: AMSCO
• Common Device Name: 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 ; 4402597401
• MDR Report Key: 24760076
• Report Number: 9680353-2026-00015
• Device Sequence Number: 13317002
• Product Code: MEC
• UDI-Device Identifier: 00724995214418
• UDI-Public: (01)00724995214418(11)250422
• 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): 04/01/2026

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
• Device Model Number: 1215
• Device Catalogue Number: FW12112
• 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: 03/05/2026
• Initial Report FDA Received Date: 04/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/22/2025
• 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