MAUDE Adverse Event Report: STERIS MEXICO, S. DE R.L. DE C.V. AMSCO; STERILIZER

Model Number	AMSCO 600 STEAM STERILIZER
Medical Device Problem Code	Device Slipped (1584)
Health Effect - Clinical Code	Abrasion (1689)
Date of Event	02/17/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris service technician arrived onsite following the reported event to inspect the unit and found that the brackets of the rack and shelf assembly were bent causing the shelves to slip off.To resolve the issue, the technician ordered a new rack and shelf assembly.A follow-up report will be submitted once the repairs have been made.A 3-year complaint review indicates this to be an isolated event.No additional issues have been reported.
Event or Problem Description
The user facility reported that while an employee was unloading instruments from their amsco 600 sterilizer, a loaded shelf slipped off bracket and contacted the employee's hand resulting in a bruise.No medical treatment was sought or administered.
Additional Manufacturer Narrative
The technician replaced the rack and shelf assembly, tested the unit, confirmed it to be operating according to specifications, and returned it to service.No additional issues have been reported.

• Brand Name: AMSCO
• Common Device Name: STERILIZER
• Manufacturer (Section D): STERIS MEXICO, S. DE R.L. DE C.V.; avenida avante 790; parque industrial guadalupe; guadalupe, 67190 ; MX 67190
• Manufacturer (Section G): STERIS MEXICO, S. DE R.L. DE C.V.; avenida avante 790; parque industrial guadalupe; guadalupe, 67190 ; MX 67190
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060 ; 4402597401
• MDR Report Key: 24627720
• Report Number: 3005899764-2026-00022
• Device Sequence Number: 15602570
• Product Code: FLE
• UDI-Device Identifier: 00724995179236
• UDI-Public: (01)00724995179236(11)240807
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2026

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: AMSCO 600 STEAM STERILIZER
• Device Catalogue Number: EF1101142
• 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: 02/18/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/18/2026
• Supplement Report FDA Received Date: 04/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/16/2024
• 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